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Annual Review 2019

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top 100 dIaGNoStIcS advaNceS oF 2019

Test Detects Protein Associated with Alzheimer’s and CTE



n ultrasensitive test has been developed that detects a corrupted protein associated with Alzheimer’s disease and chronic traumatic encephalopathy (CTE). The advance could lead to early diagnosis of these conditions and how they originate. A team of scientists collaborating with the Rocky Mountain Laboratories (NIAID, Hamilton, MT, USA: concluded that the distinctive seeding activity exhibited by Alzheimer disease (AD) and CTE tau filaments compared to other types of tauopathies in these seeded polymerization reactions provides a mechanistic basis for their consistent propagation as specific conformers in patients with 3R/4R tau diseases. Importantly, AD RT-QuIC also provides rapid ultrasensitive quantitation of 3R/4R tau-seeding activity as a biomarker. The study was published on December 20, 2018, in the journal Acta Neuropathologica.

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MI, USA; collected blood samples from patients with pancreatic cancer or a benign condition involving the pancreas, and from healthy subjects. The authors concluded that sTRA is a validated serological biomarker of pancreatic ductal adenocarcinoma (PDAC) that yields improved performance over CA19-9. The new panels may enable surveillance for PDAC among people with elevated risk, or improved differential diagnosis among patients with suspected pancreatic cancer. Brian Haab, PhD, a professor and the study’s leading author, said, “We hope that our new test, when used in conjunction with the currently available test, will help doctors catch and treat pancreatic

cancer in high-risk individuals before the disease has spread.” The study was published online on January 7, 2019, in the journal Clinical Cancer Research.

New Blood Tests for TB Could Accelerate Diagnosis


team of British scientists working with the Imperial College London (London, UK; carried out a prospective study comparing existing commercially available interferon-gamma releaseassays (IGRA) against new generation tests in patients with suspected Tuberculosis (TB) in hospitals in England. Patient blood samples

Molecular Prognostic Biomarker Found for CNS Lymphoma


cientists at Kyoto Prefectural University of Medicine (Kyoto, Japan; deciphered the MicroRNA (miRNA) signature through analysis between the expression patterns of miRNAs and their correlation to the prognosis in primary central nervous system lymphoma (PCNSL) specimens. They first selected 16 miRNA candidates from the 847 miRNAs detected using microarray technique. Then based on principal component analysis (PCA) after Random forest analysis and clustering analysis, they determined that miR181b, miR-30d, and miR-93 constituted a miRNA signature in PCNSL. The miRNAs have been implicated in processes ranging from new blood vessel formation to cell migration, proliferation, and immune function, the team noted, and were highly expressed in almost half the PCNSLs tested. The study was published on January 7, 2019, in the journal Public Library of Science ONE.

Blood Test Diagnoses Pancreatic Cancer Disease Earlier



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Annual Review 2019 were analyzed using both sets of tests, the results of which benchmarked against a confirmed diagnoses based on positive culture results. Ajit Lalvani, DM, a professor of Infectious Diseases and a co-author of the study, said, “Stopping the use of the existing, inadequate tests could save a lot of money. In contrast, the new, more accurate rapid blood test will improve and accelerate diagnostic assessment of patients with suspected TB.” The study was published on January 14, 2019, in the journal Lancet Infectious Diseases.

Tumor Mutational Load Predicts Survival Post-Immunotherapy


large team of scientists working with the Memorial Sloan Kettering Cancer Cen-

Blood Test Improves Detection of Severe Transplant Rejection

Year’s Top 100 Diagnostics Advances ter (New York, NY, USA; analyzed DNA sequence data for advanced cancers from more than 1,600 people who had been treated with immunotherapies called checkpoint inhibitors (ICI). The study looked at ten different kinds of cancer, including melanoma and breast cancer. Findings in selected cancer types suggest that tumor mutational burden (TMB) may predict clinical response to ICI. In most of those cancers, the team found that a higher number of mutations were associated with a better chance of responding to checkpoint inhibitors. The data also showed that the number of mutations that predicted a good response to immunotherapy varied from one type of cancer to another. The study was published on January 14, 2019, in the journal Nature Genetics.


team of scientists working with the National Heart, Lung and Blood Institute (Bethesda, MD, USA; monitored lung transplant recipients. The results showed that those with higher levels of the donor-derived DNA fragments (ddcfDNA) in the first three months of transplantation were six times more likely to subsequently develop transplant organ failure or die during the study follow-up period than those with lower donor-derived DNA levels. Hannah Valantine, MD, a professor of cardiovascular medicine and a co-leader of the study, said, “We showed for the first time that donor-derived DNA is a predictive marker for chronic lung rejection and death, and could provide critical time-points to intervene, perhaps preventing these outcomes. Once rejection is detected early via this test, doctors would then have the option to increase the dosages of anti-rejection drugs, add new agents that reduce tissue inflammation, or take other measures to prevent or slow the progression.” The study was published on January 26, 2019, in the journal EBioMedicine.

Simple Inexpensive Test Screens for Esophageal Cancer



cientists from Johns Hopkins University School of Medicine (Baltimore, MD, USA; www. sought to develop a Barrett’s esophagus (BE) detection method based on methylation status in cytology samples captured by EsophaCap (Capnostics LLC, Doylestown, PA, USA; www. using a technique known as methylation on beads (MOB). Stephen J. Meltzer, a gastroenterologist and a professor of medicine and oncology and senior author of the study, said, “It’s actually possible to miss early cancerous cells using endoscopy with biopsy and most patients with Barrett’s don’t ever undergo endoscopy. Right now, we’re confident that we have the tools to identify this type of cancer. But we previously lacked a way to collect enough genetic material to confidently determine a patient’s diagnosis. We believe that EsophaCap now provides a solution to this serious problem.” The study was published on January 22, 2019, in the Clinical Cancer Research.

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CSF Liquid Biopsy Sequencing Tracks Glioma Evolution

Annual Review 2019

Year’s Top 100 Diagnostics Advances


team of scientists led by the Memorial Sloan Kettering Cancer Center (New York, NY, USA; tracked traces of gliomas in cerebrospinal fluid (CSF) by collecting samples from patients who previously received a lumbar puncture because they showed neurological signs or symptoms of brain tumors. Michael Berger, PhD, a coauthor of the study, said, “Compared to other liquid biopsy applications, cerebrospinal fluid has the potential to enable more sensitive detection of circulating tumor DNA (ctDNA) because most of the cell-free DNA in CSF is shed from tumor cells. There is very little background DNA from non-cancerous cells, in contrast to plasma where often only a tiny fraction of the cell-free DNA is actually derived from tumor cells.” The study was published on January 23, 2019, in the journal Nature Research.

Neurodegenerative Diseases (Tübingen, Germany; studied a rare form that has the name dominantly inherited Alzheimer’s disease (DIAD), or autosomal dominant Alzheimer’s disease. Neurofilament light chain (NfL) is a promising fluid biomarker of disease progression for various cerebral proteopathies. The authors concluded that NfL dynamics in serum predict disease progression and brain neurodegeneration at the early presymptomatic stages of familial Alzheimer’s disease, which supports its potential utility as a clinically useful biomarker. Brian Gordon, PhD, who is an assistant professor of radiology and co-author of the study, said, “This is something that would be easy to incorporate into a screening test in a neurology clinic.” The study was

published on January 21, 2019, in the journal Nature Medicine.

Newborn Genomic Sequencing Detects Disease Risk Factors


ewborn genomic sequencing (nGS) provides many potential opportunities in the clinical management of a newborn, including identifying the risk for a broad range of disorders in babies who are asymptomatic at birth, and thereby expand the spectrum of conditions for which screening is possible. A team of scientists collaborating with the Brigham and Women’s Hospital (Boston, MA, USA; analyzed a combination of healthy and ill newborns, to

DNA Methylation Test Detects Early Aggressive Prostate Cancer


large international team led by scientists at the University College Dublin (Dublin, Ireland; www. collected pre-biopsy, post- digital rectal examination (DRE) urine samples and used the epiCaPture (Epigenetic Cancer of the Prostate Test in Urine) assay, which detects aberrant methylation in six prostate cancer-associated genes (GSTP1, SFRP2, IGFBP3, IGFBP7, APC, and PTGS2) via polymerase chain reaction (PCR). The authors concluded that epiCaPture is an effective urine DNA methylation test for high-risk prostate cancer (PCa), with a tumor specificity out-performing that of prostate-specific antigen. Used as an adjunct to prostate-specific antigen, epiCaPture could aid patient stratification to determine need for biopsy. The study was published on January 14, 2019, in the Journal of Clinical Oncology.

Blood Test Detects Brain Damage Years Before Symptoms


team including scientists from the Washington University School of Medicine in St. Louis, (MO, USA; https://medicine.wustl. edu) and the German Center for


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Annual Review 2019 find that 9.4% have a genetic variant which poses the risk of a disorder that is clinically manageable during childhood, or a variant in a gene for which there was moderate evidence of risk, but for which an intervention during childhood might prevent devastating outcomes later in life. Robert C. Green, MD, MPH, a professor and co-author of the study, said, “The BabySeq Project is the first randomized trial of sequencing in newborns and the first study to fully examine the wealth of unanticipated genetic risk information in children. We were stunned by the number of babies with unanticipated genetic findings that could lead to disease prevention in the future.” The study was published on January 3, 2019, in the journal American Journal of Human Genetics.

Urinary Detection Method Developed For Prostate Cancer


Year’s Top 100 Diagnostics Advances

he conventional methods for prostate cancer (PCa) PCa screening recommended by the American Cancer Society are serum prostate specific antigen (PSA) testing and digital rectal examination (DRE). However, these methods have some drawbacks due to their sensitivity, specificity, and accuracy. More recently, the PCA3 gene has shown promise as a non-invasive PCa biomarker. Scientists at Mahidol University (Bangkok, Thailand; developed an assay based on interactions between unmodified gold nanoparticles (AuNPs) and thiolated polymerase chain reaction (PCR) products. The

method is deemed promising for discrimination of prostate cancer patients from both healthy controls and benign prostatic hyperplasia patients according to their urinary PCA3 expression levels. The results indicated that the proposed colorimetric assay was more sensitive than gel electrophoresis. The study was published in the January 2019 issue of the journal Clinica Chimica Acta.

Blood Test Improves Detection of Severe Transplant Rejection


cientists have developed a simple blood test that can detect when a newly transplanted lung is being rejected by a patient, even when no outward signs of the rejection are evident. A large team of scientists working with the National Heart, Lung and Blood Institute (Bethesda, MD, USA; www. showed that transplant recipients with higher levels of visit us at the donor-derived DNA fragments (ddcfDNA) in the first three months of transplantation were six times MedlaB Stand Z2h59 more likely to subsequently develop transplant organ failure or die during the study follow-up period than those with lower donor-derived DNA levels. The team found that more than half of the high-risk subjects showed no outward signs of clinical complications during this period. The authors showed for the first time that donor-derived DNA is a predictive marker for chronic lung rejection and death, and could provide critical time-points to intervene, perhaps preventing these outcomes. Once rejection is detected early via this test, doctors would then have the option to increase the dosages of anti-rejection drugs, add new agents that reduce tissue inflammation, or take other measures to prevent or slow the progression. The study was published on January 26, 2019, in the journal EBioMedicine.

Bacterial Pathogen Discovered in Brains of Alzheimer’s Patients



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ecent characterization of amyloid-β (Aβ) as an antimicrobial peptide has renewed interest in identifying a possible infectious cause for Alzheimer’s disease (AD). An international team of scientists including those from the University of Louisville School of Dentistry (Louisville, KY, USA; investigated the prevalence of Porphyromonas gingivalis in the AD brain in order to elucidate possible P. gingivalis–dependent mechanisms of labMedica International December/2019-January/2020


Annual Review 2019

Year’s Top 100 Diagnostics Advances action for neurodegeneration and AD pathology. P. gingivalis is mainly found during gingival and periodontal infections; however, it can also be found at low levels in 25% of healthy individuals with no oral disease. In preclinical studies the scientists demonstrated that by inhibiting the compound COR388, there was reduced bacterial load of an established P. gingivalis brain infection, blocked Aβ42 production, reduced neuroinflammation and protected neurons in the hippocampus, the part of the brain that mediates memory and frequently atrophies early in the development of AD. The study was published on January 23, 2019, in the journal Science Advances.

Simple Inexpensive Test Screens for Esophageal Cancer


cientists from Johns Hopkins University School of Medicine (Baltimore, MD, USA; www.hopkins and their associates sought to develop a Barrett’s esophagus (BE) detection method based on methylation status in cytology samples captured by EsophaCap (Capnostics LLC, Doylestown, PA, USA; using a streamlined sensitive technique, known as methylation on beads (MOB). The authors concluded that EsophaCap, in combination with an epigenetic biomarker panel and the MOB method, is a promising, welltolerated, low-cost esophageal sampling strategy for BE diagnosis. Stephen J. Meltzer, a gastroenterologist and a professor of medicine and oncology and senior author of the study, said, “It’s actually possible to miss early cancerous cells using endoscopy with biopsy, and most patients with Barrett’s don’t ever undergo endoscopy. We believe that EsophaCap now provides a solution to this serious problem.” The study was published on January 22, 2019, in the Clinical Cancer Research.

The authors concluded that commercially available IGRAs do not have sufficient accuracy for diagnostic evaluation of suspected tuberculosis. Second-generation tests, however, might have sufficiently high sensitivity, low negative likelihood ratio, and correspondingly high negative predictive value in low-incidence settings to facilitate prompt rule-out of tuberculosis. Ajit Lalvani, DM, a professor of Infectious Diseases and a co-author of the study, said, “Stopping the use of the existing inadequate tests could save the NHS a lot of money. In contrast, the new, more accurate rapid blood test will improve and accelerate diagnostic assessment of patients with suspected TB.” The study was published on January 14, 2019, in the journal Lancet Infectious Diseases.

Genetic Causes of Salivary Gland Carcinoma Discovered


large team of scientists led by those at the University of Erlangen-Nuremberg (Erlangen, Germany; enrolled patients with diagnosis of AciCC of the salivary glands in the initial study cohort, and their tumor material underwent extensive comprehensive genetic and epigenetic profiling. The team used genome sequencing on tumor tissue, and identified a translocation of genetic material between chromosomes 4 and 9, which was present in all acinic cell carcinomas examined. The activation signals of the regulatory elements in the acinic cell carcinoma caused the

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New Blood Tests For TB Could Accelerate Diagnosis


team of British scientists working with the Imperial College London (London, UK; carried out a prospective study comparing commercially available interferon-gamma releaseassays (IGRA) against new generation tests, in patients with suspected TB in 10 NHS hospitals in England.


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Annual Review 2019 gene to be switched on again. NR4A3 acted as a transcriptional factor to regulate the activity of a number of other genes, which then triggered cell division and growth, leading ultimately to the tumor starting to grow. The study was published on January 21, 2019, in the journal Nature Communications.

Genes Associated with Age-Related Macular Degeneration Identified


team of scientists from different institutions working with the US National Eye Institute (Bethesda, MD, USA; https://nei. studied retinas, the eye tissue affected by Age-Related Macular Degeneration (AMD), from deceased human donors with and without AMD. The analysis involved se-

quencing each retina’s ribonucleic acid (RNA), the messenger molecule that carries instructions from DNA for making proteins. Among the most plausible target genes were B3GLCT and BLOC1S1, which could affect AMD-related cell functions such as signaling.The scientists used transcriptome-wide association analysis (TWAS) to identify three additional genes, RLBP1, HIC1 and PARP12. The analysis also suggested as many as 20 additional candidate genes providing insights into pathways involved in pathobiology of AMD. The study was published on February 11, 2019, in the journal Nature Genetics.

Unnecessary Testing for Urinary Tract Infections Significantly Reduced


new study indicates that making a simple change to the electronic system used by doctors to order urine tests can cut by nearly half the number of bacterial culture tests ordered without compromising the ability to identify people who need treatment for urinary tract infections (UTI). David K. Warren, MD, a professor of medicine and the senior author of the study at the Washington University School of Medicine (St Louis, MO, USA; said, “Over-testing for UTIs drives up health-care costs and leads to unnecessary antibiotic use which spreads antibiotic resistance. We were able to reduce the number of tests ordered substantially without diminishing the quality of care at all, and at a substantial cost savings.” The study was published on February 21, 2019, in the journal Infection Control and Hospital Epidemiology.

Novel Test Measures Pain Biomarkers in Blood

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Circulating Plasma DNA Potentially Identifies Incipient Tumors

Year’s Top 100 Diagnostics Advances

team of scientists at the Indiana University School of Medicine (Indianapolis, IN, USA; were successful in identifying blood gene expression biomarkers that were predictive of pain state, and of future emergency department (ED) visits for pain, more so when personalized by gender and diagnosis. Alexander Niculescu, MD, PhD, an Associate Professor of Psychiatry and Medical Neuroscience, and the lead author of the study, said, “The biomarker is like a fingerprint, and we match it against this database and see which compound would normalize the signature. We found some compounds that have been used for decades to treat other things pair the best with the biomarkers. We have been able to match biomarkers with existing medications, or natural compounds, which would reduce or eliminate the need to use the opioids.” The study was published on February 12, 2019, in the journal Molecular Psychiatry.


team of Belgian and Dutch investigators led by those at the University Hospitals Leuven (Leuven, Belgium; developed a unique genomic profiling method for cfDNA called The Genomic Imbalance Profiling from cfDNA SEQuencing (GIPseq) method. The authors concluded that their results illustrated the GIPseq’s effectiveness in detecting incipient hematologic malignancies and clonal mosaicism with unknown clinical significance in healthy patients. They demonstrated that cell-free DNA (cfDNA) screening detects genome-wide copy number alterations (CNA), which are not only derived from peripheral blood, but even more from other tissues. Since the clinical relevance of clonal mosaics in other tissues remains unknown, longterm follow-up is warranted. The study was published January 1, 2019, in the journal Annals of Oncology.

Simple Bile Acid Blood Test Predicts Stillbirth Risk


ntrahepatic cholestasis of pregnancy (ICP) is caused by a build-up of bile acids in the blood, and symptoms include pruritus. ICP is a liver disorder affecting approximately 5,300 pregnancies annually in the UK, more than 14 every day. A large team of international scientists collaborating with Kings College London (London, UK; analyzed more than 170,000 pregnancies from 40 international studies to understand the link between ICP, bile acid levels and stillbirth. The results of the study show that for the majority of women with ICP, who have bile acid concentration below 100 μmol/, the risk of stillbirth is not significantly greater than that of pregnant women without ICP. This means they need no further treatment other than regular bile acid blood tests for the remainder of their pregnancy. Caroline Ovadia, BCh, a Clinical Lecturer and first author of the study, said, “This marks a real step forward in the diagnosis and management of liver disorders during pregnancy. Being able to measure the risks to women and their babies by simple tests allows doctors to concentrate treatment on those who really need it.” The study was published on February 14, 2019, in the journal The Lancet.

Cancer-Associated Circular RNAs Catalogued Across Tumors


team of scientists from the University of Michigan (Ann Arbor, MI, USA; used exome capture and RNA sequencing to profile circular ribonucleic labMedica International December/2019-January/2020



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Annual Review 2019 acids (circRNAs) in more than 800 tumors, cell line, or pooled normal samples assessed for the Michigan Oncology Sequencing Center (MIONCOSEQ) program. The analyses led to nearly 129,000 circRNAs in 40 cancer types, which they compared to more than 60,000 circRNAs previously compiled in the CircBase database. The investigators used the team’s cancer-associated circRNA collection known as MiOncoCirc and identified candidate circRNAs to serve as biomarkers for prostate cancer that were able to detect circRNAs in urine. They further detected a novel class of circular transcripts, termed readthrough circRNAs that involved exons originating from different genes. MiOncoCirc will serve as a valuable resource for the development of circRNAs as diagnostic or therapeutic targets across cancer types. The study was published on February 7, 2019, in the journal Cell.

Blood Test Detects Alzheimer’s Before Symptoms Appear

Year’s Top 100 Diagnostics Advances


blood-based assessment of preclinical disease would have huge potential in the enrichment of participants for Alzheimer’s disease (AD) therapeutic trials. A large international team of scientists led by the group from King’s College London (London, UK; reported that preliminary testing showed their new technique to be 90% accurate in matching results obtained from PET scan testing. They reported also that their system found 10 protein features that together represent a biomarker, two of which had been identified as possibilities previously. The authors concluded that using an unbiased MS approach, they found and replicated with high accuracy, specificity, and sensitivity a plasma protein classifier reflecting Aβ burden in a cognitively unimpaired cohort. These predictive panels highlighted novel and established markers for AD. The study was published on February 6, 2019, in the journal Science Advances.

Alzheimer’s Disease Meta-Analysis Identifies New Risk Genes


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very large team of scientists led by those at the University of Miami Miller School of Medicine (Miami, FL, USA; www. uncovered 21 loci reaching genome-wide significance associated with risk of late-onset Alzheimer’s disease (LOAD), 18 of which had previously been identified. After an overall meta-analysis, they identified 13 novel loci. The team noted that pathway analysis showing that tau is involved in lateonset Alzheimer’s confirms that therapies targeting tangle formation or degradation could potentially affect late-onset disease. Their analysis of risk genes and disease-linked pathways also indicated an enrichment of rare variants in late-onset Alzheimer’s disease risk and suggested there might be additional rare variants to find if larger samples are studied. The study was published on February 28, 2019, in the journal Nature Genetics.

Blood Test Predicts Kidney Transplant Rejection


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cientists at the Guy’s and St Thomas’ NSH Foundation Trust (London, UK; www. and their colleagues analyzed blood samples serially from consecutive kidney transplant recipients (KTRs), transplanted at a single regional transplant center. They concluded that molecular marker alterations in blood emerge

well ahead of the time of clinically overt TCMR. Monitoring a TCMR-signature in peripheral blood could unravel T-cell-related pro-inflammatory activity and hidden immunological processes. This additional information could support clinical management decisions in cases of patients with stable but poor kidney function or with inconclusive biopsy results. Paramit Chowdhury, MD, PhD, a consultant nephrologist and a senior author of the study, said, “This advance could make a huge difference to our ability to monitor kidney transplant patients and treat rejection earlier. It may also save some patients from an unnecessary biopsy.” The study was published on March 1, 2019, in the journal EBioMedicine.

Paper-Based Technology Enables Malaria Detection


n international team of scientists led by the University of Glasgow (Glasgow, UK; developed a test that consists of origami paper-based microfluidic sample preparation using hot wax printing to form channels that either repel or attract blood moving through the structure by capillary force prior to detecting DNA that is specific to malaria. Almost all the cost for the platform in its current form is for the freeze-dried enzymes and reagents that are used to trigger an isothermal amplification event that makes the device sensitive enough to differentiate between disease pathogens, even when they are present at such low abundance that the individual is asymptomatic. The authors concluded that their results demonstrated that paper-based microfluidic devices can deliver precision diagnostics for malaria in low-resource, underserved settings with a sensitivity that is higher than that of the current malaria diagnostic tests used in the field (such as microscopy and RDTs) and with performance that is similar to that of a laboratory-based real-time PCR test. The study was published on February 19, 2019, in the journal Proceedings of the National Academy of the Sciences.

Adverse Drug Response Risk Gene Identified for Inflammatory Bowel Disease


large international team led by those at the Royal Devon and Exeter Hospital (Exeter, UK; carried out a case-control study of patients affected by thiopurine-induced myelosuppression (TIM) and thiopurine-tolerant unaffected patients. The authors concluded that among patients of European ancestry with inflammatory bowel disease (IBD), variants in NUDT15 were associated with increased risk of TIM. Gareth Walker, MRCP, a gaslabMedica International December/2019-January/2020



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Annual Review 2019 troenterology specialist and first author of the study, said, “We hope that once a predictive test is developed, patients will be able to have a simple blood test before starting these drugs. This will allow doctors to modify treatments, either by reducing the dose or opting for different treatment altogether.” The study was published on February 26, 2019, in the Journal of the American Medical Association.

Urine Test Allows for Rapid Preeclampsia Diagnosis


reeclampsia (PE) is a multisystem disorder specific to human pregnancy, and its incidence varies from 5% to 60% of gestations, depending on maternal co-morbidities. PE has a large spectrum of medical signs and symptoms resulting in a range of clinical phenotypes and outcomes, making a diagnosis on available clinical and laboratory parameters challenging. Hypertension and proteinuria are non-specific, and thus major challenges arise when differential diagnosis includes chronic hypertension, endocrine, and kidney diseases. Scientists at The Ohio State University College of Medicine (Columbus, OH, USA; developed and validated a simple bedside, paperbased urine test kit, which they named the CR Dot (CRD) Paper Test. Kara M. Rood, MD, a maternal-fetal medicine physician and first author of the study, said, “This is the first clinical study using the point-of-care, paperbased Congo Red Dot (CRD) diagnostic test, and the mechanism proved superior in establishing or ruling out a diagnosis of preeclampsia. Our findings will have a huge impact on the health of women and children.” The study was published on March 1, 2019, in the journal EClinicalMedicine.

Year’s Top 100 Diagnostics Advances

Suite of Risk Variants Revealed In Hirschsprung’s Disease



cientists at several institutions collaborated with those at Johns Hopkins University (Baltimore, MD, USA; and genotyped and exome-sequenced samples from patients with Hirschsprung’s disease to quantify the genetic burden in patients with this condition. DNA sequence variants, large copy number variants (CNVs), and karyotype variants in probands were considered to be pathogenic when they were significantly associated with Hirschsprung’s disease or another neurodevelopmental disorder. The authors concluded that among the patients in their study, Hirschsprung’s disease arose from common noncoding variants, rare coding variants, and copy-number variants affecting genes involved in enteric neural-crest cell fate that exacerbate the widespread genetic susceptibility associated with regulatory deficiency in the gene encoding receptor tyrosine kinase (RET). The study was published on April 11, 2019, in the New England Journal of Medicine.

Machine-Learning System Used to Diagnose Genetic Diseases


large team of scientists collaborating with the Rady Children’s Institute for Genomic Medicine (San Diego, CA, USA; www. have optimized and integrated several time-saving technologies into a rapid Whole Genome Sequencing (rWGS) process to screen from a blood sample, a child’s entire genetic makeup for thousands of genetic anomalies. Michelle Clark, PhD, the

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first author of the study, said, “Using machinelearning platforms doesn’t replace human experts. Instead it augments their capabilities. By informing timely targeted treatments, rapid genome sequencing can improve the outcomes of seriously ill children with genetic diseases.” The study was published on April 24, 2019, in the journal Science Translational Medicine.

Early Sepsis Detection Test Approved


test for the early detection of sepsis has been approved for marketing in the United States as an in vitro diagnostic product. In line with evidence that early antibiotic treatment of sepsis leads to improved patient survival, the Early Sepsis Indicator produced by Beckman Coulter (Brea, CA, USA; www. has received marketing clearance from the FDA. The test identifies sepsis patients with proven accuracy, providing the opportunity for clinicians to institute treatment when antibiotics are most effective. The Early Sepsis Indicator kit was designed for use on automated hematology instruments such as the new Beckman Coulter DxH 900 Hematology Analyzer. Results obtained by the test improves diagnosis of sepsis by 43% and, together with clinical signs and symptoms, improves the ability to rule out sepsis by 63%.

DNA Sequencing Advances Huntington’s Diagnosis


ntil recently individuals with symptoms of Huntington’s disease needed to have a blood test and wait up to four weeks for the result. Viapath (London, UK; www.viapath. has recently introduced Oxford Nanopore long read sequencing technology into its Genetics Laboratory. The technology allows them to rapidly sequence long stretches of DNA using a small palm-sized device. Unlike short read ‘next generation’ sequencing; long read sequencing provides the ability to sequence the entire HTT cytosine, adenine, and guanine (CAG) repeat region in a single read. The scientists used the MinION (Oxford Nanopore Technologies, Oxford, UK; www. which is a small handheld device that “decodes” individual strands of DNA in real-time. It identifies any changes in the DNA sequence and then matches these to a library of known genetic sequences to detect presence of the genetic disorder. Most current technologies provide segments of DNA sequence that need to be analyzed at a later date, leading to a longer wait for results.

Genomic Classifier Test for Lung Disease


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Annual Review 2019 requires a pattern of usual interstitial pneumonia to be present on high-resolution chest computerized tomography (HRCT) scan or surgical lung biopsy. In cases where a CT scan is inconclusive, diagnosis is often achieved by a surgical lung biopsy, which can cause complications. A team of scientists working with the University of Washington Medical Center (Seattle, WA, USA; www. has used diagnostic histopathology and RNA sequence data to train a machine-learning algorithm in order to identify a usual interstitial pneumonia pattern. The authors concluded that the molecular test provided an objective method to aid clinicians and multidisciplinary teams in ascertaining a diagnosis of IPF, particularly for patients without a clear radiological diagnosis, in samples that can be obtained by a less invasive method. The study was published on April 1, 2019, in the journal Lancet Respiratory Medicine.

Multi-Gene Panel Testing Catches Cancer Risk Variants


team of scientists collaborating with the genetic testing company Invitae (San Francisco, CA, USA; analyzed de-identified sequence data for 83 cancer-risk genes in patients with breast, ovarian, CRC, prostate, and pancreatic cancer, referred for hereditary cancer genetic testing. When the Invitae Multi-Cancer 83-gene comprehensive panel was applied, the overall diagnostic yield for all patients with breast, ovarian, pancreatic, prostate and CRC increased almost 4fold to 16%. Excluding mono-allelic P/LP variants in predominantly recessive cancerrisk genes (e.g. MUTYH) reduces the diagnostic yield to 13%. Stratified by cancer type, and removing mono-allelic recessives, positive

Year’s Top 100 Diagnostics Advances yield was: breast 11.8%, ovarian 18%, prostate 15%, pancreatic 16% and CRC 19%. The authors concluded that genetic testing guidelines should be expanded to include clear recommendations supporting multi-gene panel testing in patients with cancer, to improve the care of patients and their family members. The study was presented at the American College of Medical Genetics and Genomics annual meeting held April 2-6, 2019, in Seattle, WA, USA.

Certain Bacteria Strains Associated With Diabetic Wounds


cientists at the University of Pennsylvania School of Medicine (Philadelphia, PA, USA; and their colleagues investigated the role of colonizing microbiota in diabetic wound healing, clinical outcomes, and response to interventions, and conducted a longitudinal, prospective study of patients with neuropathic diabetic foot ulcers (DFU). Their findings suggest that the DFU microbiota may be a marker for clinical outcomes and response to therapeutic interventions. Elizabeth A. Grice, PhD, an associate professor of Dermatology and the lead author of the study, said, “Our study increases understanding of how microbes impair or promote wound healing. It is possible there are bacteria that actually benefit the wound, and we can use what we learned in this study to develop new treatment strategies for non-healing wounds. We hope this study will eventually help identify patients at risk for bad outcomes and lead to treatment innovations that these patients desperately need.” The study was published on April 18, 2019, in the journal Cell Host and Microbe.

Blood Test May Predict Cardiovascular Disease



ardiac troponins are structural proteins found in the myofibrils of cardiomyocytes. Development of high sensitivity assays for cardiac troponin I and T (hs-TnI and hs-TnT) has enhanced the ability to detect low circulating levels of cardiac troponins, which are often present in individuals with common cardiac conditions and risk factors who have not manifested clinical cardiovascular disease (CVD). Cardiologists and their associates at Baylor College of Medicine (Houston, TX, USA; who analyzed a group of people aged 54-74 as part of the “Atherosclerosis Risk in Communities” (ARIC) study, concluded that elevated hs-TnI is strongly associated with increased global CVD incidence in the general population independent of traditional risk factors and that hs-TnI and hs-TnT provide complementary rather than redundant information. The study was published on April 29, 2019, in the journal Circulation.

Primary Fatty Amides Produce Blood Test for Alzheimer Disease


large international team of scientists led by Kings College London (London, UK; found that the level of the fatty molecules which induce sleep in blood were higher in those with amyloid in the brain, the peptide used to diagnose Alzheimer’s disease. Cristina Legido-Quigley, PhD, an associate professor and lead author of the study, said, “This is the first study in which lipid molecules produced in the brain are found in the blood, as amyloid deposition increases in Alzheimer’s disease. These fatty amides are known to be neuroprotective and to induce sleep. There is also evidence that amyloid accumulates in the brain with lack of sleep, so these molecules may be playing a role in clearing up toxic amyloid in the brain. A blood test for Alzheimer’s would be cheaper than measuring amyloid in the brain and easier to do than a spinal tap.” The study was published on May 8, 2019, in the journal Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.

Genomic Data Affects Prognosis of Advanced Prostate Cancer


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Annual Review 2019 tion-resistant prostate cancer (mCRPC) who also had clinical data available. The authors concluded that that RB1 loss is the molecular factor most strongly associated with poor clinical outcomes in a contemporary cohort, highlighting the need for further investigation into mechanisms of resistance to AR therapies induced by loss of RB, and potential therapeutic strategies targeting this mechanism. The study was published on May 6, 2019, in the journal Proceedings of the National Academy of Sciences.

Urinary Biomarkers Diagnose Serious Kidney Allergic Reaction


large team of scientists collaborating with Johns Hopkins Medicine (Baltimore, MD, USA; enrolled participants who were scheduled to undergo a clinically indicated kidney biopsy. Three renal pathologists independently evaluated biopsy slides to establish acute interstitial nephritis (AIN) diagnosis. Chirag Parikh, PhD, a nephrologist and senior author of the study said, “Because both cytokines are seen in allergic diseases such as atopic dermatitis and food allergies, and AIN most often is the result of an allergic response, it makes sense to consider using them as diagnostic tools. If biopsy diagnoses are considered 100% accurate, then IL9 had a very comparable ranking of 84%, and this was significantly better than the 62% to 69% achieved by clinicians without biopsies.” The study was published on May 16, 2019, in the Journal of Clinical Investigation Insight.

Biomarker Test Developed for Chronic Fatigue Syndrome


yalgic encephalomyelitis, or chronic fatigue syndrome (ME/CFS), is a serious

Year’s Top 100 Diagnostics Advances condition that may affect up to 2.5 million people in the USA alone. Currently, physicians can only diagnose ME/CFS by examining a person’s symptoms and medical history, and by excluding other possible illnesses. This can make the diagnosis process difficult, lengthy, and inaccurate. A new diagnostic test looks at how a person’s immune cells react to stress. Scientists at the Stanford University School of Medicine (Stanford, CA, USA; www. have developed a nanoelectronics assay designed as an ultrasensitive test capable of directly measuring biomolecular interactions in real time, at low cost, and in a multiplex format. Rahim Esfandyarpour, PhD, a Bioengineer and first author of the study, said, “Using the nanoelectronics assay, we can add controlled doses of many different potentially therapeutic drugs to the patient’s blood samples and run the diagnostic test again.” The study was published on April 29, 2019, in the journal Proceedings of the National Academy of Sciences.

Simple and Inexpensive Ebola Virus Disease Test Developed


arly symptoms of Ebola and Marburg, include fever, headache and diarrhea, and mimic more common diseases, so there’s a critical need for a rapid diagnostic test. Such a test could help in efforts to limit outbreaks by quickly quarantining infected persons. But existing diagnostic tests either are inaccurate or are expensive and require extensive training to administer. Scientists at the Loyola University Health System (Maywood, IL, USA; have generated a panel of mouse single-chain Fv-antibodies (scFvs) to filovirus glycoproteins (GPs) using cell-free ribosome display and determined their cross-reactivity profiles to all known

filovirus species. The team used a technology called cell-free ribosome display, and generated two synthetic antibodies that bind to all six Ebola and Marburg viruses. The antibodies, which are inexpensive to produce, potentially could be used in a simple filter paper test to detect Ebola virus and the related Marburg virus. If the filter paper turns color, the virus is present. The study was published on May 6, 2019, in the American Journal of Tropical Medicine & Hygiene.

Urine Test Could Prevent Cervical Cancer


uman papilloma virus (HPV) detection in urine has recently been considered as an alternative means to identify women at increased risk of high-grade cervical intraepithelial neoplasia (CIN2+). Of the 100 or so types of HPV, some are linked to cervical cancer, and some are linked to other conditions, like genital warts, while most cervical cancers are caused by high-risk types HPV-16 and HPV-18. Medical scientists collaborating with those at the University of Manchester (Manchester, UK; collected urine, vaginal and cervical samples from consecutive women attending the local colposcopy clinic. The authors concluded that urinary HR-HPV testing has good sensitivity for the detection of CIN2+ in a colposcopy clinic cohort. The study suggests that vaginal HR-HPV testing is slightly more sensitive than urine HR-HPV testing; however urine self-sampling may be more acceptable to cervical screening non-attenders than vaginal self-sampling. The study was published on April 29, 2019, in the journal BMJ Open.

Plasma Copeptin Reveals Presence and Severity of Liver Disease




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asopressin (VP) is a hormone secreted by the pituitary gland in response to increased plasma osmolality, low plasma volume, and low blood pressure. Copeptin is a cleavage product of the C-terminal part of the VP precursor which correlates well with plasma VP concentrations and which is easier to measure reliably. In humans, elevated circulating copeptin levels have been independently associated with increased risk of type 2 diabetes mellitus (T2DM), cardiovascular morbidity and mortality, and clinical signatures of metabolic syndromes (MS). Researchers at the Sapienza University (Rome, Italy; https:// reported that obese patients with biopsy-proven non-alcoholic fatty liver disease (NAFLD) had significantly higher copeptin levels than both obese individuals without NAFLD and non-obese subjects. The labMedica International December/2019-January/2020



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Annual Review 2019 authors concluded that increased plasma copeptin is independently associated with the presence and severity of NAFLD and NASH, pointing to a novel mechanism behind human fatty liver disease potentially modifiable by pharmacological treatment and lifestyle intervention. The study was published on April 30, 2019, in the journal BMC Medicine.

Invasive Pulmonary Aspergillosis Diagnosed By Molecular Test


nvasive aspergillosis (IA) is a common opportunistic fungal infection, mainly affecting patients with severe and prolonged neutropenia. Early diagnosis of invasive pulmonary aspergillosis (IPA) is notoriously difficult, but crucial for prompt treatment initiation required to improve patient outcome. The mycological evidence used for the diagnosis of probable IPA includes traditional microbiological microscopy and culture of a respiratory specimen, along with non-culture-based serological tests, like that of GM antigen in serum and bronchoalveolar lavage (BAL) fluid, as well as β-d-Glucan in serum. Medical scientists from Rambam Health Care Campus (Haifa, Israel; and their associates performed bronchoscopies using a fiber-optic bronchoscope with cardiopulmonary monitoring. After a 12-year study period, the authors concluded that including PCR test for the detection of Aspergillus DNA in BAL in the mycological criteria of the EORTC/MSG definitions increases the rate and the certainty of IPA diagnosis. The study was published in the June 2019 issue of the International Journal of Infectious Diseases.

Flow Cytometry Predicts Transplant Rejection


nderstanding the immunological phenotype of transplant recipients on standard immunosuppression, immune-cell therapies and new drug treatments is essential for improving transplantation outcome. Immune monitoring by multi-color flow cytometry is a highly useful tool to assess the immune response in transplantation, and has the potential to shed insight on the mechanisms responsible for successful treatment. Islet transplantation is a frontier therapy for type 1 diabetes with notable success in hypoglycemic patients, where pancreatic beta cells from a donor are transplanted into a recipient, enabling the body to produce insulin, and regulate blood sugar. Scientists from Westmead Institute for Medical Research (Sydney, Australia; demonstrated the procedure's utility in making longitudinal evaluations in islet transplant patients and that it has the potential for monitoring transplant patients and other patients on

Identifying Colorectal Cancer Subtypes Improves Treatment Decisions

Year’s Top 100 Diagnostics Advances long-term immunosuppression and for determining if any changes in leukocyte subsets are associated with outcomes. The study was published on May 22, 2019, in the journal PLOS ONE.

Machine Learning Approach Detects Cancer by Analyzing DNA in Blood Samples


hile cell-free DNA in the blood provides a non-invasive diagnostic avenue for patients with cancer, characteristics of the origins and molecular features of cell-free DNA are poorly understood. To correct this lack, investigators at Johns Hopkins University (Baltimore, MD, USA; developed a machine learning-based approach to identify abnormal patterns of DNA fragments in the blood of patients with cancer. They used this DELFI (DNA evaluation of fragments for early interception) method to analyze the fragmentation profiles of patients with breast, colorectal, lung, ovarian, pancreatic, gastric, or bile duct cancer against healthy individuals. “We are encouraged about the potential of DELFI because it looks at a completely independent set of cellfree DNA characteristics from those that have posed difficulties over the years, and we look forward to working with our collaborators worldwide to make this test available to patients,” said senior author Dr. Victor E. Velculescu, professor of oncology at Johns Hopkins University. The DELFI method was described in the May 29, 2019, online edition of the journal Nature.

Whole-Blood Test for Acute Zika Infections


everse transcription polymerase chain reaction (RT-PCR) is currently the most reliable method for confirming Zika virus infections. Diagnostics are based on Zika virus RNA detection, detection of Zika virus–specific antibodies, or both. Scientists at the Erasmus Medical Center (Rotterdam, the Netherlands; compared Zika virus quantitative reverse transcription PCR (qRT-PCR) results for EDTA–whole blood and EDTA–plasma pairs submitted for laboratory testing from patients with suspected Zika virus infection. The authors concluded that that individual patient care might benefit from whole-blood testing in a routine diagnostic laboratory setting, thereby possibly reducing the need for more specialized serology (i.e., comparative flavivirus neutralization tests) to confirm cases based on serology. Therefore, they have implemented whole blood RT-PCR testing for Zika virus diagnostic requests in our routine diagnostic setup. The study was published in the July 2019 issue if the journal Emerging Infectious Diseases.


he Consensus Molecular Subtype (CMS) system categorizes colorectal cancer into four distinct, biologically characterized subgroups based on how mutations in the tumor behave. An international team of oncology specialists led by the University of Southern California (Los Angeles, CA, USA; www. compared the efficacy of two different therapies (chemotherapy and cetuximab versus bevacizumab) on metastatic colorectal cancer patients categorized by CMS. They characterized the CMS classification using a novel NanoString gene expression panel (Seattle, WA, USA; www.nanostring. com) on primary CRCs to assess the prognostic and predictive value of CMS in patients. Heinz-Josef Lenz, MD, a Professor of Medicine and lead author of the study said, “We wanted to understand the importance of CMS for patients with metastatic disease who are treated with the two most important first-line therapies. We anticipated that CMS had prognostic value, but we were impressed at how strongly CMS was associated with outcomes. This study establishes the clinical utility of CMS in treating colorectal cancer.” The study was published on May 8, 2019, in the Journal of Clinical Oncology.

Improved Test for Ovarian Cancer


iomedical scientists from Uppsala University (Uppsala, Sweden; compared circulating plasma levels of 593 proteins in three cohorts of patients with ovarian cancer and benign tumors, using the proximity extension assay (PEA). An additional 552 proteins were analyzed using six additional PEA-panels and real-time polymerase chain reaction (PCR) using the Fluidigm BioMark HD real-time PCR platform (South San Francisco, CA, USA; in the discovery and replication cohorts. Ulf Gyllensten, PhD, Professor of Medical Molecular Genetics and corresponding author of the study, said, “Our results are promising enough to consider screening for early discovery of ovarian cancer. In Sweden, we have long experience of screening for cervical cancer. I see great prospects of developing a strategy for screening for ovarian cancer as well, which could save lives and minimize the need for surgery to rule out cancer.” The study was published on June 20, 2019, in the journal Communications Biology.

Alzheimer’s Stratified by APOE Genotype


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Annual Review 2019 body. It is implicated in Alzheimer’s disease and cardiovascular disease. The gene, APOE, is mapped to chromosome 19 in a cluster with apolipoprotein C1 (APOC-I) and the apolipoprotein C2 (APOC-2). An international team of scientists led by those at Boston University Schools of Medicine (Boston, MA, USA; examined exome sequence data for unrelated individuals with AD against cognitively normal control individuals, all with non-Hispanic white ancestry. The authors concluded that their study identified multiple possible novel associations for AD with individual and aggregated rare variants in groups of individuals with and without APOE ε4 alleles that reinforce known and suggest additional pathways leading to AD. The study was published on June 10, 2019, in the journal JAMA Neurology.

Circulating T Cell-Monocyte Complexes Indicate Immune Perturbations



ommunication between immune cells is a major component of immune responses, either directly through cell-cell contacts or indirectly through the secretion of messenger molecules such as cytokines. A team of international scientists led by the La Jolla Institute for Immunology (La Jolla, CA, USA; www. showed that cell:cell doublets pairing a T cell and a monocyte can be directly isolated from human blood, and high resolution microscopy shows polarized distribution of LFA1/ICAM1 in many doublets, suggesting in vivo formation. Intriguingly, T cell-monocyte complex frequency and phenotype fluctuate with the onset of immune perturbations such as infection or immunization, reflecting expected polarization of immune responses. Bjoern Peters, PhD, a professor in the Vaccine Discovery Division at LJI and senior author of the study, said, “It’s an important lesson learned by studying these cells and how they communicate, we might learn more about the immune system.” The study was published on June 25, 2019, in the journal eLife.

Bacteriophage-Based Blood Test Rapidly Detects TB Bacteria


blood test based on bacteriophage that infect living Mycobacterium tuberculosis (Mtb) bacteria has been shown to diagnose human tuberculosis (TB) and may be able to predict which patients with latent tuberculosis will progress to the active form of the disease. Dr. Pranabashis Haldar, at the Leicester Biomedical Research Centre (United Kingdom; said, “Our observations provide new insights into how human

Molecular Test Accurately Distinguishes Breast Tumors

Year’s Top 100 Diagnostics Advances TB develops and support recent evidence of the existence of a transitional state of TB infection called incipient TB that does not produce symptoms but carries a high risk of progressing to active TB. There is potential for Actiphage to be developed, both as a mainstream blood test to diagnose TB and as a test used in screening programs to help us identify and treat people with latent infection.” The study was published in the June 22, 2019, online edition of the journal Clinical Infectious Diseases.

Blood Biomarkers Help Predict Recovery Time After Concussion


study of high school and college football players suggests that biomarkers in the blood may have potential use in identifying which players are more likely to need a longer recovery time after concussion. A team of scientists associated with the Medical College of Wisconsin (Milwaukee, WI, USA; looked at levels of seven biomarkers for inflammation that have been related to more severe brain injury that included serum levels of interleukin (IL)–6, IL-1b, IL-10, tumor necrosis factor, C-reactive protein, interferon-g, and IL-1 receptor antagonist. Of the seven biomarkers, two were elevated for those with concussion at six hours after the injury compared to the athletes with no concussion. The biomarkers Il-6 and interleukin 1 receptor antagonist (IL1RA) were both elevated at six hours after concussion. The study was published on July 3, 2019, in the journal Neurology.

Test Improves Accuracy in Identifying Precancerous Pancreatic Cysts


n international team led by Johns Hopkins Kimmel Cancer Center (Baltimore, MD, USA; showed that a laboratory test using artificial intelligence tools offers the potential to more accurately sort out which people with pancreatic cysts will go on to develop pancreatic cancers. Christopher Wolfgang, MD, PhD, MS, a Professor of Surgery and a senior author of the study, said, “Currently available clinical and imaging tests often fail to distinguish precancerous cysts from cysts that have little or no potential to turn cancerous, which makes it difficult to determine which patients will not require follow-up and which patients will need long-term follow-up or immediate surgical resection. As a result, essentially all people diagnosed with a cyst are followed long-term. This study directly addresses these fundamental problems in management of pancreatic cysts.” The study was published on July 17, 2019, in the journal Science Translational Medicine.


new laboratory test has been developed to identify chemical changes to a group of cancer-related genes that can accurately detect which breast tumors are cancerous or benign, and do it in far less time than gold-standard tests on biopsied breast tissue. A team led by investigators from the Johns Hopkins Kimmel Cancer Center (Baltimore, MD, USA; www.hopkins evaluated the utility of 25 genes that previous studies have shown are often, although not always, methylated differently in breast cancer and benign lesions. A novel technology platform developed by Cepheid (Sunnyvale, CA, USA; provided methylation marker results within five hours. Eventually, they narrowed their candidate genes to a panel of 10 with methylation characteristics that were more likely able to distinguish between a majority of the malignant and benign training samples. The study was published in the July 2019 issue of the journal Clinical Cancer Research.

Mutation Study Suggests Changes to Clinical Management


ynch syndrome (LS) results from pathogenic variants in the mismatch repair (MMR) genes and is the most common hereditary cancer syndrome, affecting an estimated 1 in 300 individuals. Pathogenic variants in each of the MMR genes path_MLH1, path_MSH2, path_MSH6, and path_PMS2 result in different risks for cancers in organs including the colorectum, endometrium, ovaries, stomach, small bowel, bile duct, pancreas, and upper urinary tract. A multinational group led by the Oslo University Hospital (Oslo, Norway; https://oslo-universitetssyke found that the lifetime risk of colorectal cancer for MLH1 and MSH2 pathogenic mutation carriers in the cohort was 50%, despite patients being followed with colonoscopy and having suspicious polyps removed. The investigators proposed a redefinition of the term Lynch syndrome to encompass four clinically distinct inherited cancer risk syndromes. More specifically, they argued, PMS2 mutation carriers should not be grouped together with carriers of MLH1 and MSH2 pathogenic variants, considering that both genetic counseling and clinical management would differ for the two groups. The study was published on July 24, 2019, in the journal Genetics in Medicine.

BRCA2 Mutations Linked to Pediatric Non-Hodgkin Lymphoma Risk


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Annual Review 2019 found a statistically significant association between lymphoma and mutations in BRCA2. When they stratified the patients by disease type, they found that the statistical significance held for a link between BRCA2 mutations and non-Hodgkin lymphoma, though not for Hodgkin lymphoma. Additionally, six of the seven childhood non-Hodgkin lymphoma survivors for whom the scientists were able to get family histories had family histories of BRCA2-related cancers like breast, prostate, pancreatic and melanoma cancer. The authors concluded that pediatric or adolescent non-Hodgkin lymphoma could possibly be included in the list of cancers associated with germline BRCA2 mutations. Further, they argued that non-Hodgkin lymphoma survivors could possibly benefit from increased surveillance for other BRCA2-linked cancers. The study was published on July 25, 2019, in the JAMA Oncology.

Test Indicates Need For Chemotherapy


nvasive lobular carcinoma (ILC) is the most common special type of breast cancer, and is characterized by functional loss of E-cadherin, resulting in cellular adhesion defects. ILC typically present as estrogen receptor positive, grade 2 breast cancers, with a good short-term prognosis. A team of medical scientists led by The University of Queensland (Herston, QLD, Australia; accessed fresh frozen tumors and matching blood samples and used integrative analysis of gene expression and DNA copy number to identify novel drivers and prognostic biomarkers, using inhouse, 125 METABRIC and 146 TCGA samples. The authors concluded that the molecular signature, LobSig, which captures the peculiar genomic landscape of ILC tumors, together with clinico-pathology information, provides a robust mechanism for prognostication in ILC. The study was published on June 27, 2019, in the journal npj Breast Cancer.

Biomarker Panel Accurately Predicts Risk of Mortality


nvestigators at the Max Planck Institute for Biology (Cologne, Germany) and the Leiden University Medical Center (The Netherlands) used a well-standardized metabolomics platform to identify metabolic predictors of longterm mortality in blood samples from individuals aged 18–109. Meta-analysis of the results enabled the investigators to identify 14 circulating biomarkers associated independently with all-cause mortality. The set of 14 biomarkers included, among other indicators, various amino acids, levels of LDL and HDL cholesterol, fatty acid balances, and inflammatory factors. The 14 biomarkers were involved in various metabolic processes, such as lipoprotein

Year’s Top 100 Diagnostics Advances and fatty acid metabolism, glycolysis, fluid balance, and inflammation. Although the majority of these biomarkers have been associated with mortality before, this is the first study to demonstrate their independent effect when combined into one model. The study was published in the August 20, 2019, online edition of the journal Nature Communications.

Potential Biomarkers Found in Glioblastoma Small Extracellular Vesicles



nvestigators at the University of Sussex (United Kingdom; revealed that the content of small extracellular vesicles (sEVs) mirrored the phenotypic signature of the respective glioblastoma (GBM) cells, leading to the description of potential informative sEV-associated biomarkers for GBM subtyping, such as CD44. Coupled with noninvasive liquid biopsy techniques, the use of sEV biomarkers is expected to provide insights for the development of new diagnostic and therapeutic methods as well as personalized treatment strategies. Senior author Dr. Georgios Giamas, professor of cancer cell signaling at the University of Sussex, said, “At the moment, the outlook for glioblastoma patients is bleak. As the most aggressive type of brain tumor, survival rate is low. Our research provides more information about the markers which can signal the presence of glioblastoma - and the fact we have been able to identify ones that are associated with extracellular vesicles, suggests that there could be a way to use bodily fluids to test for the tumor in the future.” The GBM sEVs paper was published in the August 19, 2019, online edition of the journal Communications Biology.

Protein Biomarker Panel Enables Early Detection of Cancer


nalysis of biomarker expression data from serum obtained from ovarian cancer patients has enabled development of an early detection tool for epithelial ovarian cancer (EOC). Investigators at Queens University of Belfast (UK; and collaborators in the UK, Australia, and Italy analyzed samples from EOC cases (Type I and Type II) plus controls who were participants in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Senior author Dr. Robert (Bobby) Graham, reader in the school of biological sciences at Queen’s University Belfast, said, “Firstly, we discovered that the presence of the biomarker panel will enable us to detect EOC. We then developed a screening test to detect this biomarker panel, making this a relatively simple diagnostic test. The algorithm

designed will screen the blood sample and flag any abnormal levels of the proteins associated with the cancer. The screening test identifies ovarian cancer up to two years before the current tests allow. The results of this study are encouraging, however, we now want to focus on testing it in a wider sample set so that we can use the data to advocate for an ovarian cancer screening program.” The study was published in the August 7, 2019, online edition of the British Journal of Cancer.

Brain Biomarkers Predict Alzheimer’s Disease Risk and Progression


cluster of genes has been identified that modulates the activity of TREM2 (Triggering receptor expressed on myeloid cells 2), a protein biomarker for risk and progression of Alzheimer’s disease (AD). Soluble TREM2 (sTREM2) has been detected in human cerebrospinal fluid (CSF), where it was found to be elevated in CSF of patients with multiple sclerosis and other inflammatory neurological conditions in comparison to patients without inflammatory neurologic disorders. In order to better understand the role of sTREM2 in AD, investigators at Washington University School of Medicine (St. Louis, MO, USA; www. performed a genome-wide association study (GWAS) to identify genetic modifiers of sTREM2 in samples of CSF provided by the Alzheimer’s Disease Neuroimaging Initiative ( Results revealed that common variants in the membrane-spanning 4-domains subfamily A (MS4A) gene region were associated with CSF sTREM2 concentrations. The variants associated with increased CSF sTREM2 concentrations were linked to reduced AD risk and delayed age at onset of disease. A single-nucleotide polymorphism (SNP) modified expression of the MS4A4A and MS4A6A genes in multiple tissues, suggesting that one or both of these genes were important for modulating sTREM2 production. The study was published in the August 14, 2019, online edition of the journal Science Translational Medicine.

Fungus-Associated Bacteriome Associated With C. Difficile Infection



team of scientists collaborating with the University of Arizona (Tucson, AZ, USA; reported that distinct bacterial and fungal compositions distinguished Clostridioides difficile infection (CDI) in positive and negative patients, with the greatest differentiation between the cohorts observed based on bacterial metatranscriptomics. Bipartite network analyses demonstrated that AslabMedica International December/2019-January/2020


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Annual Review 2019 pergillus and Penicillium taxa shared a strong positive relationship in CDI patients and together formed negative co-occurring relationships with several bacterial taxa, including the Oscillospira, Comamonadaceae, Microbacteriaceae, and Cytophagaceae. The investigators identified new pathways associated with C. difficile infections. Those pathways pointed to still other bacterial species, including Escherichia coli that may contribute to the dysbiosis, or imbalance among bacterial species in the gut, associated with C. difficile. David B. Stewart, MD, a surgeon and first author of the study, said, “The development of C. difficile infection is apparently influenced both by bacterial pathogens and fungi particular to this disease. Until now, fungi have been understudied and under-appreciated in the gut microbiome.” The study was published on August 28, 2019, in the journal mSphere.

Vaping Respiratory Illness Characterized by Lipid-Laden Cells in Lungs


hysicians at the University of Utah Health (Salt Lake City, UT, USA; identified lipid-laden macrophages in all six cases of vaping illness seen at University of Utah Hospital. The cells were found in samples after performing a procedure called bronchoalveolar lavage where fluid is squirted into a small section of the lungs and then collected for examination. Bronchoalveolar lavage (BAL) fluid showed neutrophilic predominance (49%) and more than 50% lipid-laden macrophages by oil red O staining. Testing of this fluid by culture and polymerase-chain-reaction assay for bacterial, fungal, and viral pathogens did not reveal any evidence of infection. The question remains as to whether the vaping respiratory illness is a type of lipoid pneumonia. Despite similarities, there are also differences. Unlike the vaping illness, classic lipoid pneumonia is typically seen in older individuals, typically caused by accidentally breathing in oil-based laxatives. Classic lipoid pneumonia also presents differently on x-rays of the lungs. Additional testing will need to be done to determine whether the vaping illness can be categorized as a new kind of lipoid pneumonia. The study was published on September 6, 2019, in the New England Journal of Medicine.

Gut Bacteria Linked to High Blood Pressure and Depression


cientists from the University of Florida College of Medicine (Gainesville, FL, USA; studied bacteria in the gut and discovered unique patterns of bacteria from people with (a) high blood pressure plus depression; (b) high blood pressure without depression; (c) depression with healthy blood

Year’s Top 100 Diagnostics Advances pressure; or (d) healthy subjects without depression or high blood pressure. The authors concluded that the results suggest different medical mechanisms of high blood pressure that correlate with signature molecules produced by gut bacteria. These molecules are thought to impact the cardiovascular system, metabolism, hormones and the nervous system. Bruce R. Stevens, PhD, a Professor of Physiology & Functional Genomics, Medicine and Psychiatry and the lead author of the study, said, “People are ‘meta-organisms’ made up of roughly equal numbers of human cells and bacteria. Gut bacteria ecology interacts with our bodily physiology and brains, which may steer some people towards developing high blood pressure and depression. We believe we have uncovered new forms of high blood pressure: ‘Depressive Hypertension’ (high blood pressure with depression), which may be a completely different disease than ‘Non-Depressive Hypertension’ (high blood pressure without depression), which are each different from ‘Non-Hypertensive Depression.” The study was presented at the American Heart Association’s Hypertension 2019 Scientific Sessions on September 5, 2019, in New Orleans, LA, USA.

detection. The procedure is usually performed in reference laboratories, which complicates and delays the delivery of blood for transfusion. Scientists at the Institute of Hematology and Transfusion Medicine (Warsaw, Poland; have reviewed the advances in applying next-generation sequencing (NGS) to transfusion medicine for the purpose of genotyping alleles encoding clinically important red blood cell and platelet antigens. The currently available technologies allow various levels of sequencing; either the whole genome (WGS), coding regions, exons (WES) or only selected genes or regions of interest. NGS technology significantly reduces the cost of testing. It has been successfully implemented in transplantation medicine for testing donors’ genotypes of HLA antigens in high-throughput mode. The authors concluded that the future of NGS as a supplementary test used to provide highly compatible blood as well as to reduce the risk of patient’s alloimmunization and this is part of personalized medicine. The study was published on September 3, 2019, in the journal International Journal of Clinical Transfusion Medicine.

New Strain of Bacteria Causes Scarlet Fever

Biomarker Panel Used For Pleural and Peritoneal Effusions Diagnosis


Next-Gen Sequencing Matches Blood Group Antigens for Transfusion

Breakthrough Kit May Enable Early Alzheimer’s Diagnosis


cientists at the University of Sao Paulo (San Paulo, Brazil; evaluated Samples of pleural or peritoneal fluid from 120 patients submitted to thoracentesis or paracentesis for diagnostic investigation. Each sample was representative of one patient. The team evaluated the following biomarkers: carcinoembryonic antigen (CEA), vascular endothelial growth factor A (VEGF-A) programmed death-ligand 1 (PD-L1/B7-H1), neutrophil gelatinase-associated lipocalin (NGAL), triggering receptor expressed in myeloid cells type-1(TREM-1), and gamma-interferon (IFNγ). The authors concluded that a hybrid panel composed by the biomarkers CEA, NGAL, IFNγ and ADA seems to be useful in discriminating between malignant effusion (ME) and tuberculous pleural effusion (TPE) etiology, both lymphocytic effusions. For nontuberculous infectious effusion, the panel did not demonstrate diagnostic advantages over classic literature parameters. The study was published in the October 2019 issue of the journal Clinica Chimica Acta.


xtended antigen typing is time-consuming, serological methods are costly and depend on the availability of reagents for antigen

nfectious disease specialists at the Imperial College London (London, UK; identified the Strep A strains causing scarlet fever infections across England and Wales, as defined by the type of emm gene present. They found that the initial upsurge of scarlet fever in 2014 in London was associated with Strep A strain types emm3 and emm4. However, during the spring of 2015 and 2016, emm1 strains became dominant among throat infections. The investigators found that the majority of emm1 strains from 2015 and 2016 were a distinct, breakaway emm1 clone, which they refer to as M1UK. The clone had 27 unique mutations, and was associated with significantly increased production of the toxin streptococcal pyrogenic exotoxin A (SpeA). Shiranee Sriskandan, FRCP, a Professor of Infectious Diseases and senior author of the study, said, “The distinct bacterial clone we have discovered appears so far to be largely limited to the UK, but the fact that we have identified two examples of it elsewhere suggests it has the potential to spread internationally and may already be present in other countries.” The study was published on September 10, 2019, in the journal The Lancet Infectious Diseases.


cientists at the Gyeongsang National University (Jinju, Republic of Korea; www. developed a WO2002/088706 kit labMedica International December/2019-January/2020


Annual Review 2019

Year’s Top 100 Diagnostics Advances that is composed of fluorescent nanoparticles for the early detection of Alzheimer’s Disease (AD). The kit consists of a probe molecule comprising an oligonucleotide capable of detecting one or more AD-specific microRNAs (miRNAs) and biomarkers related to AD. The team used the plasma from AD patients to confirm that their fluorescent nanoparticles and the kit will provide a possible early diagnosis to serve as an AD detector that can be further improved for future studies on targeting AD. The authors concluded that the physiological response genetically reflects the early stages of inflammation ex vivo before the appearance of a phenotype that does not appear in the early stages of inflammation. If the miRNA and antigens related to AD are selected as biomarkers, the molecular image sensor can be used as part of a useful kit for the early diagnosis of AD. The study was published on September 12, 2019, in the journal Scientific Reports.

ever, since clinical implementation studies of maternal plasma cell‐free (cf)-DNA testing have demonstrated a much higher sensitivity and specificity for these trisomies, health policy analyses have called for more cost‐effective cfDNA tests to enable a wide adoption of first‐line screening. An international collaboration of scientists led by those at Vanadis Diagnostics (PerkinElmer, Sollentuna, Sweden; analyzed maternal plasma samples from singleton pregnancies, which included fetal aneuploidies. Reference outcomes were determined by amniocentesis or chorionic villi sampling (CVS), followed by cytogenetic testing, such as karyotyping, fluorescence in situ hybridization (FISH) or quantitative fluorescence-polymerase chain reaction (QF‐PCR) or clinical examination of

neonates. The authors concluded that cfDNA testing with the highly automated Vanadis NIPT system does not require specialized personnel for screening. The Vanadis system is also designed to help reduce cost and allow wider population-based screening. The study was published on August 19, 2019, in the journal Prenatal Diagnosis.

New Guidelines Advance Diagnosis Of Fungal Infections


imely diagnosis of fungal infections, which are of increasing incidence and importance in immunocompromised and immunocompetent patients, relies on appropriate use of laboratory testing in susceptible patients. To

Parkinson’s Gene Mutation Linked to Higher Risk of Leukemia


utations in the leucine rich repeat kinase 2 (LRRK2) gene are one of the most commonly known genetic causes of Parkinson’s disease. A large team of scientists collaborating with the Albert Einstein College of Medicine (Bronx, NY, USA; www. studied the prevalence of cancer among Parkinson’s Disease (PD) patients with the LRRK2 mutation. Cancer outcomes were compared among LRRK2‐PD patients, Idiopathic Parkinson’s Disease (IPD) patients of unknown causes, and controls recruited from LRRK2 consortium centers. Their findings indicated that the LRRK2 G2019 mutation might be associated with the development of several types of cancer. Ilir Agalliu, MD, PhD, an associate professor and first author of the study, said, “We might consider that if someone is a carrier of the LRRK2 G2019S mutation they should be closely monitored for Parkinson’s and for certain cancers.” The study was published in the September 2019 issue of the journal Movement Disorders.

Novel Cell-Free DNA Screening Assay Validated for Trisomies


renatal screening for trisomies 21, 18, and 13 is currently performed using multiple maternal serum and ultrasound markers. How-


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Annual Review 2019 this end, a panel of experts appointed by the American Thoracic Society (New York, NY, USA; conducted a systematic review of medical studies on diagnosing fungal infections that had been published in the past decades, in order to compile an official guideline. Guideline co-chair Dr. Andrew H. Limper, professor of pulmonary medicine at the Mayo Clinic (Rochester, MN, USA; www., said “This guideline summarizes the best available evidence on the use of common laboratory tests to diagnose invasive pulmonary aspergillosis, invasive candidiasis, as well as histoplasmosis, blastomycosis, and coccidioidomycosis.” The guideline was published in the September 1, 2019, issue of the Journal of Respiratory and Critical Care Medicine.

New Blood Test Helps Detect Brain Injury in Minutes


fter traumatic brain injury (TBI), plasma concentration of glial fibrillary acidic protein (GFAP) correlates with intracranial injury visible on computerized axial tomography (CT) scan. Some patients with suspected TBI with normal CT findings show pathology on magnetic resonance imaging (MRI). Recently scientists have found that a handheld blood analyzer could help detect brain injury within 15 minutes, using a commercial system that measures GFAP and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) proteins from the brain that are released into the blood after a brain injury. Neurologists at the University of California at San Francisco (San Francisco, CA, USA; studied patients with TBI that were treated at various trauma centers in the USA. The study concluded that analysis of blood GFAP concentrations using prototype assays on a point-of-care platform within 24 hours of injury might improve detection of TBI and identify patients who might need subsequent MRI and follow-up. The study was published on August 23, 2019, in the journal The Lancet Neurology.

Protein Panel Developed for Early Detection of Lung Cancer


creening with low-dose computed tomography (LDCT) has proven effective at reducing lung cancer mortality in high-risk populations, but there is still considerable uncertainty and debate about how to best define these populations. Currently, this is primarily done based on age and smoking history, but protein and other biomarkers could play a role as well. Scientists at the University of Manchester (Manchester, UK; www. analyzed serum samples from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) biobank. The

Year’s Top 100 Diagnostics Advances team used blood collected during surgical resection of lung tumors in an iTRAQ isobaric tagging experiment to identify proteins effluxing from tumors into pulmonary veins. Using hierarchical clustering and principal component analysis, they identified a panel of 11 proteins that distinguished between cases and controls one year prior to diagnosis with sensitivity of 88% and specificity of 89%. Anthony D. Whetton, PhD, a Professor and lead author of the study, said, “I think the ideal is that we have a blood-borne biomarker test for risk and stratification, so that one can look at the results of this test and determine whether further follow-up is required. I think that’s the space that is awfully important with respect to lung cancer.” The study was published on August 13, 2019, in the Journal of Proteome Research.

New Blood Test Capable of Detecting Multiple Cancer Types



new blood test developed by GRAIL, Inc (Menlo Park, CA, USA; https://grail. com) can screen for over 20 types of cancer with a high degree of accuracy. The test uses next-generation sequencing technology to probe DNA for tiny chemical tags (methylation) that influence whether genes are active or inactive. The test looks for DNA, which cancer cells shed into the bloodstream when they die. In contrast to “liquid biopsies,” which detect genetic mutations or other cancer-related alterations in DNA, the technology focuses on modifications to DNA known as methyl groups. Scientists at the Dana-Farber Cancer Institute (Boston, MA, USA; used the test to analyze cell-free DNA in an extensive study of blood samples comprising over 20 types of cancer, including hormone receptor-negative breast, colorectal, esophageal, gallbladder, gastric, head and neck, lung, lymphoid leukemia, multiple myeloma, ovarian, and pancreatic cancers. The results showed an overall specificity of 99.4%, meaning only 0.6% of the results incorrectly indicated that cancer was present. The study was presented at the European Society for Medical Oncology (ESMO) 2019 Congress, held September 27 to October 1, in Barcelona, Spain.

Triple-Negative Breast Cancer Classified from Whole-Genome Sequencing


n triple-negative breast cancer (TNBC), the three most common types of receptors known to fuel most breast cancer growth– estrogen, progesterone, and the HER-2/neu gene are not present in the cancer tumor.

An international team of scientists led by those at Lund University (Lund, Sweden; sequenced TNBC tumors by applying the machine-learning algorithm HRDetect to the genome sequences. The investigators divided the TNBC tumors into three groups: low, intermediate, and high, as per how deficient they were in homologous recombination-based gene repair. The researcher found that these groups had varying prognoses and responses to treatments and that HRDetect represents a novel means of stratifying tumors. Johan Staaf, PhD, an associate professor of oncology and pathology, and first author of the study, said, “Using whole-genome sequencing, we can truly discriminate tumors that may or may not respond to current drugs among triple-negative breast cancer patients, a type of breast cancer that we still struggle to treat well.” The study was published on September 30, 2019, in the journal Nature Medicine.

Artificial Intelligence Set to Transform Clinical Microbiology


joint undertaking between two University of Utah research affilates has developed the world’s first AI-augmented ova and parasite detection tool. The technology can quickly screen out negative results, allowing laboratorians to spend more time analyzing positive slides. The ova and parasite tool was co-developed by ARUP Laboratories (Salt Lake City, UT, USA; and Techcyte (Lindon, UT, USA; “The collaboration with Techcyte has produced an AI-augmented detection tool that significantly advances our diagnostic capabilities in our parasitology lab,” said Adam Barker, PhD, director of Research and Development at ARUP. “This will allow for faster turnaround times, decreased costs, employee satisfaction and improved patient care.”

Chromosomal Abnormalities Associated with Recurrent Miscarriage



n international team of scientists led by those at Shandong University (Jinan, China; performed low-pass genome sequencing on couples with recurrent miscarriages (RM). A customized sequencing and interpretation pipeline was developed to identify chromosomal rearrangements and deletions/duplications with confirmation by fluorescence in situ hybridization, chromosomal microarray analysis, and polymerase chain reaction (PCR) studies. Cynthia Morton, PhD, a director of cytogenetics and co-author of the study, said, “The labMedica International December/2019-January/2020


Annual Review 2019

Year’s Top 100 Diagnostics Advances new technique we've used here increases the number of couples who we can see are at risk for having miscarriage.” The authors concluded that low-pass GS identified underlying chromosomal aberrations in 1 in 9 RM-affected couples, enabling identification of a subgroup of couples with increased risk of subsequent miscarriage who would benefit from a personalized intervention. The study was published on October 31, 2019 in the American Journal of Human Genetics.

Cardiac Biomarkers Identify High-Risk Kidney Disease Patients


here is growing evidence that impaired kidney function and raised albuminuria levels are risk factors for cardiovascular disease (CVD) independent of traditional factors such as hypertension and diabetes. In addition, there are pathologic mechanisms that are unique to CKD that promote vascular disease, thus contributing to the increased burden of CVD. Cardiologists from the Mayo Clinic (Rochester, MN, USA; www.mayo classified participants by renal function, characterize trends of cardiac biomarker activation and left ventricular function, and report cardiovascular outcomes over a 10-year follow-up period using data from a retrospective study, including participants from the Olmsted County Heart Function Study. Horng H. Chen, MB, BCh, a cardiologist and senior author of the study, said, “We demonstrated that NT-proBNP and hs-TnT have prognostic value regardless of kidney function. Hence, these two biomarkers can be used to identify patients with kidney disease who are at highest risk for adverse cardiac events and who would be candidates for aggressive risk factor modification to prevent adverse outcomes.” The study was published on October 23, 2019 in the journal Mayo Clinic Proceedings.

(Heidelberg, Australia; Niloufar Torkamani, MD, PhD, FRACP, an endocrinology/general medicine physician and lead author of the study, said, “We found that the presence of diabetes and higher HbA1c levels were strongly and independently associated with adverse renal outcomes at followup. Such patients are at high risk of relatively rapid deterioration in renal function and are a logical target for structured preventive interventions.” The study was published on October 22, 2019 in the Journal of Diabetes and its Complications.

CPO Test Improves Detection Of Carbapenemase Producers


he use of nucleic acid amplification tests (NAAT) to identify rapidly Carbapene-

mase-Producing Organisms (CPO) from samples such as positive blood culture and stools is an alternative approach to establish rapidly an optimal empirical antibiotic therapy or for infectious control management. Medical microbiologists at the Lausanne University Hospital (Lausanne, Switzerland; www.lausanne tested the performance of the Phoenix CPO Detect Test (Becton-Dickinson, Franklin Lakes, NJ, USA; on a collection of molecularly-characterized CPO and non-CPO. The authors concluded that the Phoenix CPO Detect test represents a new diagnostic tool with added value for the detection and management of CPO infection and colonization. The carbapenemase classification accuracy is robust to provide preliminary

Increased HbA1c Identifies Rapid Kidney Function Deterioration In Diabetics


team of scientists from the University of Melbourne (Melbourne,Australia; www.unimelb. conducted a prospective observational cohort study that traced HbA1c and eGFR data on adults with a median age of 77 years that made two or more visits to Austin Hospital


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Annual Review 2019 results before molecular characterization. The study was published on October 18, 2019 in the journal Clinical Microbiology and Infection.

Blood Test Diagnoses Brain Tumors


iagnosis of brain tumors has been previously investigated with attenuated total reflectance Fourier transform infrared (ATRFTIR) spectroscopy on dried human serum samples to eliminate spectral interferences of the water component. Rapid analysis of liquid samples would represent a promising approach for clinical translation. A team of scientists at the University of Strathclyde (Glasgow, UK; evaluated ATRFTIR on both liquid and dried samples to in-

Next Generation Glycated Hemoglobin Assay

Year’s Top 100 Diagnostics Advances vestigate “digital drying” as a novel approach for the analysis of spectra obtained from liquid samples. Matthew Baker, PhD, Reader in Chemistry, and chief scientific officer at ClinSpec Diagnostics Ltd (Glasgow, Scotland;, where the test was developed, and a senior author of the study, said, “Because the technique requires just a small blood sample, if offers the potential to test a large number of people with suspicious symptoms and give the best indication of who needs an urgent brain scan. This could ultimately speed up diagnosis, reduce the anxiety of waiting for tests and get patients treated as quickly as possible.” The study was presented at the 2019 NCRI Cancer Conference held November 46, 2019, in Glasgow, UK


esearchers at the University of Calgary (Calgary, AB, Canada; evaluated the performance of the Roche Cobas c 513 (Roche Diagnostics, Basel, Switzerland;, a stand-alone next generation immunoassay analyzer for percentage of glycated hemoglobin A1C (HbA1C). They assessed the imprecision, accuracy, analytical measuring range, and throughput of this instrument. Method comparisons studies were performed against a previous generation immunoassay analyzer (Roche Integra 800 CTS). They also studied the effects of erythrocyte sedimentation and potential interference from hemoglobin variants. The authors concluded that their data supports the routine use of the c 513 for HbA1C quantification. While care must be taken to ensure correct sample processing, the c 513 was characterized as a precise, accurate, automated high throughput analyzer for measuring HbA1C in large laboratories with HbA1C volumes of 1,500 per day or higher. The study was published on November 9, 2019 in the journal Practical Laboratory Medicine.

Immune Cells Linked To Malaria-Induced Anemia through Autoantibody Production


nemia is a common complication associated with malaria that contributes significantly to the great morbidity and mortality associated with the disease. An international team of scientists led by those at New York University School of Medicine (New York City, NY, USA; identified the production of an unusual type of immune B-cell: FcRL5+T-bet+ B-cells, that increases anti-phosphatidylserine (PS) antibody production associated with the development of anemia in patients. Ana M. Rodriguez, PhD, a Professor of Microbiology and a senior author of the study, said, "There is a great need for novel targeted treatments for malaria-induced anemia, which is common and can be fatal for many malaria patients. The unique phenotype and specificity of these immune B-cells could allow them to be used as a biomarker for anemia or as a target for new therapies.” The study was published on November 12, 2019 in the journal eLife.

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New Biomarker Discovered For Cancer Stem Cells

Epigenetic DNA Biomarkers Pinpoint Infertile Men and Predict Potential Success of Treatment

Year’s Top 100 Diagnostics Advances


team of scientists led by the University of Houston (Houston, TX, USA; https:// applied an “unbiased” peptoid combinatorial cell screen to identify highly specific ligands that bind a cancer stem cell (CSC) subpopulation of non-small cell lung cancer cells (defined by Aldefluor positivity), but not the remaining aldefluor negative cancer cells from the same preclinical model. Gomika Udugamasooriya, PhD, an assistant professor and senior author of the study, said, “We have found a new biomarker, the protein plectin, on cancer stem cells. We believe plectin may be a more common biomarker that could lead to broadly applicable drug development. Plectin is a structural protein, predominantly expressed intracellularly, but whose translocation onto the cell surface is linked to tumor invasion and metastasis. Our studies show both genotypic and phenotypic correlations between plectin and lung cancer stem cells, as well as association of high plectin expression with poor patient survival in lung adenocarcinoma, potentially identifying plectin as a biomarker for lung cancer stem cells.” The study was published on October 18, 2019 in the journal Scientific Reports.


he current primary diagnostic approach for male infertility is to assess sperm quality associated with reduced sperm number and motility, which has been historically of limited success in separating fertile from infertile males. An improved diagnostic approach, based on analysis of genome-wide alterations in sperm DNA methylation, was described recently by investigators at Washington State University (Pullman, USA; Results of the study pointed to a signature of differential DNA methylation regions (DMRs), which was associated with male infertility patients. Senior author

Annual Review 2019 Dr. Michael Skinner, professor of biological sciences at Washington State University, said "a diagnostic that tells you right away your male patient is infertile and directs you to treatment options that can work for him, would be immensely useful. In the area of therapeutics where many of the drugs on the market work only for a fraction of patients, this could ultimately save time, money and improve healthcare management."


Vaginitis Tests Offer Improvements Over Gold Standard Methods


team of medical microbiologists working with the University of Alabama at Birm-

Mycobacterium Infection Found in Gastric Patients’ Stomachs


icrobiologists at the Rajiv Gandhi Centre for Biotechnology (Thiruvananthapuram, India; https:// collected gastric biopsy specimens from patients with various gastric and esophageal symptoms ranging from mild dyspepsia, gastroesophageal reflux disorder, to severe gastric diseases like gastric cancer and who were recommended to have upper gastrointestinal endoscopy. The aim of the study was to isolate prevalent gastric bacteria under microaerobic condition and identify them by 16S rRNA gene sequence analysis. The authors concluded that that the prevalence of gastric M. abscessus is higher in the local population as compared to the prevalence of H. pylori. The route of transmission is not known at present, but water could be a source. Significance of this infection is also presently unknown, but it may have a significant role in the formation or progression of gastric disease. The study was published on November 4, 2019 in the journal PLOS Neglected Tropical Diseases.


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Annual Review 2019 ingham (Birmingham, AL, USA; conducted a prospective multicenter clinical study to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAAT) for diagnosis of BV, VVC, and trichomoniasis. The authors concluded that overall, the investigational assays had higher sensitivity and specificity than clinician's diagnoses and in-clinic assessments, indicating the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical efficacy evidence for two IVD NAATs that can detect the main causes of vaginitis. The study was published online on November 20, 2019 in the Journal of Clinical Microbiology.

Circulating Progenitor Cell Traffic Reflects Blood Vessel Repair


dentifying patients with otherwise stable coronary artery disease (CAD) who are high-risk and would benefit from more intense or invasive interventions is currently a major theme in cardiology studies. Scientists from the Emory University School of Medicine (Atlanta, GA, USA; carried out a prospective cohort study on patients with stable CAD and followed up for three years. Kasra Moazzami, MD, MPH, a cardiologist, and the first author of the study said, “A fall in circulating progenitor cells (CPC) count after exercise appears to be an independent determinant of high risk in patients with stable coronary artery disease, even after adjusting for known clinical risk factors. The information gained from the changes in CPC counts during exercise may be more useful to cardiologists in risk stratifying these pa-

Year’s Top 100 Diagnostics Advances tients than the treadmill exercise test itself.” The authors concluded that patients with CAD, a decrease in CPC counts during exercise is associated with a worse disease prognosis compared with the presence of stress-induced myocardial ischemia. The study was published on December 4, 2019 in the journal JAMA Cardiology.

Genetic Biomarkers Associated with Autism Spectrum Disorders Identified


utism spectrum disorder (ASD) refers to a group of neurodevelopmental conditions resulting in challenges related to communication, social understanding and behavior. Studies show families who have a child with ASD have a 6.9% to 19.5% chance of another child having ASD and a 30% to 40% chance of another child having atypical development. A group of scientists collaborating with the Hospital for Sick Children (Toronto, ON, Canada; studied families had at least one child (i.e., the proband) diagnosed with ASD. Lonnie Zwaigenbaum, MD, FRCP (C), a Professor of Pediatrics and a senior study author, said, “These findings add to a growing body of evidence that biomarkers might be helpful in identifying pre-symptomatic infants who are likely to develop ASD or other developmental challenges.” The study was published on December 5, 2019 in the journal Nature Communication.

High Performance of Rapid Influenza Diagnostic Test Validated


imely diagnosis and early antiviral therapy are crucial to counteract influenza spread. However, current diagnostic tools such as the real-time polymerase chain reaction (RT-PCR) are expensive and time-consuming. Some rapid influenza diagnostic tests (RIDTs) are also used to rapidly support treatment decision during influenza outbreaks. Nonetheless, RIDTs’ performance varies according to the prevalence of different influenza virus strains and the method used to determine their results. A study by large group of scientists working with the National Institute of Respiratory Diseases (INER, Mexico City, Mexico; concluded that the RIDT was useful to detect influenza cases during an outbreak setting. Effectiveness of 2016/17 influenza vaccines administered in Mexico was low, but significant. The study was published in the December, 2019 issue of the International Journal of Infectious Diseases.

Single-Cell Analysis Uncovers Regulatory Program in Rare Leukemia


ixed phenotype acute leukemia is a very rare type of leukemia where more than one type of leukemia occurs at the same time. This can happen when a person has either: both acute lymphoblastic leukemia (ALL) blasts (cancer cells) and acute myeloblastic leukemia (AML) blasts at the same time or leukemic blasts that have features of both ALL and AML on the same cell. Scientists at the Stanford University School of Medicine (Stanford, CA, USA; identified pathological molecular features of mixed-phenotype acute leukemia by first analyzing the single-cell transcriptomic and epigenetic profiles of healthy blood cells during their development. Once they established profiles of those healthy cells, they examined how the profiles of leukemic cells compared. The team concluded that their results demonstrate how integrative, multiomic analysis of single cells within the framework of normal development can reveal both distinct and shared molecular mechanisms of disease from patient samples. The study was published on December 2, 2019 in the journal Nature Biotechnology.

Rapid Method for Selecting the Proper Antibiotic to Treat Multidrug Resistant Bacteria


new diagnostic approach allows physicians to accurately identify bacterial pathogens and identify the most appropriate antibiotic labMedica International December/2019-January/2020


Annual Review 2019

Year’s Top 100 Diagnostics Advances within a period of hours rather than days. Multidrug resistant organisms are a serious threat to human health. Fast, accurate antibiotic susceptibility testing (AST) is a critical need in addressing escalating antibiotic resistance, since delays in identifying multidrug resistant organisms increase mortality and use of broad-spectrum antibiotics, further selecting for resistant organisms. A new approach that combines both phenotypic and genotypic analysis has been developed by investigators at the Broad Institute of the Massachusetts Institute of Technology and Harvard University (Cambridge, MA, USA; This rapid assay combines genotypic and phenotypic AST through RNA detection. The test, which has been named GoPhAST-R (for Genotypic and Phenotypic AST through RNA), classifies bacterial strains with 94–99% accuracy by coupling machine learning analysis of early antibiotic-induced transcriptional changes with simultaneous detection of key genetic resistance determinants. The GoPhAST-R method was described in the November 25, 2019, online edition of the journal Nature Medicine.

the December, 2019 issue of the International Journal of Infectious Diseases.

Longitudinal Molecular Trajectories of Adult Diffuse Glioma Examined


he most common malignant brain tumor in adults, diffuse glioma, is also one of the most difficult cancers to treat. It invariably relapses despite surgical, radiotherapeutic and/or chemotherapeutic interventions. But while the initial molecular characteristics have been well described in gliomas, their subsequent evolution under treatment stress remains unknown. A large international team of scientists working with the Jackson Laboratory for Genomic Medicine (Farmington, CT, USA; se-

lected high quality tumor samples on three major subtypes of diffuse glioma from patients at two time points each, which they characterized as initial and recurrence. The analyses demonstrated the highly variable nature of gliomas, but provide a framework for effective study of glioma evolution and treatment response. Roel Verhaak, PhD, a professor and computational cancer biologist and a senior author of the study, said, “The Glioma Longitudinal Analysis (GLASS) Consortium resource provides an excellent foundation to more effectively study both evolution and treatment response. Collectively, these findings will help us determine what treatment approaches will result in the greatest removal or killing of glioma cells possible.” The study was published on November 20, 2019 in the journal Nature.

Diagnosis and Monitoring of Patients with Hepatitis C Virus


he global prevalence of people with hepatitis C virus (HCV) antibodies (anti-HCV-positive) is estimated to be 115 million, and 80 million of them have an active infection (anti-HCV-positive and HCVRNA-positive). Most HCV-infected individuals remain asymptomatic for decades and only 25% of them achieve spontaneous viral clearance, while 75% develop chronic infection. Around 10%–20% of chronically infected patients develop liver cirrhosis or hepatocellular carcinoma and despite improvements in diagnosis and screening, the morbidity and mortality due to chronic HCV infection remain high. Microbiologists at the Complejo Hospitalario Navarra (Pamplona, Spain; carried out a prospective study on a sample of patients for whom viral load (VL) quantification was required. The team concluded that the hepatitis C virus core antigen demonstrated good sensitivity and specificity as a marker for the detection of active HCV infection in the diagnosis of new cases, for the detection of antiviral therapeutic failures, and for monitoring of the antiviral treatment. The study was published in


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products and services for the research, diagnosis, monitoring, and treatment of viral infectious diseases.

Advanced Instruments

USA • Norwood, MA Tel: (1) 781-320-9000 Web: E-mail: Supplies instrumentation for clinical, pharmaceutical, biotechnology, microbiology, and food laboratories. Primarily known for the application of freezing-point depression technology, current products have expanded to also include cytology, infrared, and image analysis.

labMedica International December/2019-January/2020

ALCOR Scientific

USA • Smithfield, RI Tel: (1) 401-737-3774 Web: E-mail: Manufactures, markets, and distributes clinical laboratory instrumentation such as the iSED for ESR testing. See ad oN paGe 10

Switzerland • Cham Tel: (41) 41-780-60-10 Web: E-mail: Manufactures products and immunoturbidimetry reagents for clinical chemistry, serology, serum protein, coagulation, and HbA1c analyzer.

Agro-Bio France •

A Stago Company

La Ferté Saint-Aubin Tel: (33) 238-648-350 Web: Specializes in biotechnological solutions and high quality products for immunotechnology, protein biochemistry, and platelet aggregation to serve the research projects and the needs of the academic and industrial sectors. USA • Creedmoor, NC Tel: (1) 919-255-3220 Web: E-mail: sales@

AirClean Systems

Aeon Technology

China • Shenzhen Tel: (86) 755-2650-9160 Web: E-mail: Designs and produces clinical diagnostic equipment, as well as containers and disposables.

AESKU Diagnostics

Germany • Wendelsheim Tel: (49) 6734-9622-0 Web: E-mail: Distributes ELISA kits for diagnostics of autoimmune diseases, including the AESKULISA product line. The main indications are rheumatology, antiphospholipid syndrome (APS), vasculitis, gastroenterology, hepatology, and diabetes.

Israel • Ashdod Tel: (972) 52-5989926 Web: E-mail: Develops, manufactures, and markets fluorescence-based kits for the diagnosis and monitoring of iron overload. The company also provides testing services for pharmaceutical companies and research centers worldwide.


Affinity Biologicals

Canada • Ancaster, ON Tel: (1) 905-304-9896 Web: E-mail: info@ Manufactures antibodies, purified proteins, control plasmas, calibrator plasmas, ELISA kits, and factor-deficient plasmas prepared by immunoaffinity chromatography.

Although all material in this directory is compiled from sources believed reliable, publisher cannot be held liable for any errors, omissions or inaccuracies. Inclusion, or lack of it, in this directory, does not constitute any endorsement or expression of other opinion by publisher with regard to companies, their products or services.


Agappe Diagnostics Switzerland

Argentina • Buenos Aires Tel: (54) 11 45234848 Web: E-mail: Manufactures, exports/imports medicine and biochemistry items. Products include the Automatic pH Blood Gas Analyzer, the AADEE-ZEN model and a fully automatic selective ION analyzer “AADEE-ZEN” ISE that has the capability to measure Na, K, Cl, and Ca.


Web: E-mail: Develops and manufactures in vitro rapid diagnostic tests. Products include tests for pregnancy, infectious diseases, sexually transmitted diseases, fecal occult blood, tumor markers, drugs of abuse, blood glucose, and urine reagent strips.



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LabMedica 300 Manufactures fume hoods, enclosures, and workstations designed to protect the operator or process from potentially harmful fumes, vapors, gases, and particulate.

Alfa Scientific Designs

USA • Poway, CA Tel: (1) 858-513-3888 Web: E-mail: Develops and manufactures rapid in vitro diagnostic devices to serve the point-ofcare marketplace. The company focuses on rapid immunoassays including those for the detection of drugs of abuse, fertility hormones, infectious diseases, cardiac and cancer markers.

Italy • Padua Tel: (39) 49-099-2000 Web: E-mail: Specializes in diagnostics, and offers the biotechnology field a diagnostic as well as a medical line, along with laboratory equipment and disposables.


Alpha Laboratories

AMEDA Labordiagnostik

Austria • Graz Tel: (43) 316-698069 Web: E-mail: Offers a range of products known under the AMP Diagnostics brand, including kits and equipment for clinical chemistry, immunology, hematology and coagulation, as well as urine and rapid diagnostics.

UK • London Tel: (44) 0-13-7272-8980 Web: E-mail: Develops, manufactures, and markets products necessary for hemostasis, thrombosis, and platelet function.

USA • Everett , WA Tel: (1) 425-379-2580 Web: E-mail: Develops and manufactures rapid test kits for point-of-care markets and ELISA kits for laboratories. The test kits are used to detect a number of conditions such as pregnancy, ovulation, various infectious diseases, tumors, allergies, drugs of abuse, heart, kidney, and liver functions.

Ameritek USA

Italy • Rome Tel: (39) 0774-354441 Web: E-mail: Develops, manufactures and markets instrumentation, reagents and tests for medical diagnostics, and focuses on molecular biology/microarrays, food diagnostics, environment/industry and nuclear/biology isolation.

AMS Alliance

Analyticon Biotechnologies

Germany • Lichtenfels Tel: (49) 6454-7991-0 Web: E-mail: info@ Specializes in complete system solutions for smallto medium-sized labs, including analyzers, reagents, controls, and calibrators. Product lines focus on clinical chemistry, hematology, coagulation, and urinalysis. USA • Webster, TX

Ansh Labs

Tel: (1) 281-404-0260 Web: E-mail: Specializes in immunoassays with potential applications in reproductive medicine, glucagon regulation, neurodegenerative disorders, oncology, etc. Company’s products consist of emerging and maturing assays and monoclonal antibody development that are used by research and clinical labs around the world. UK • Wokingham, Berkshire Tel: (44) 118-9795566 Web: E-mail: Develops and markets practical and cost-effective solutions in the field of medical diagnostics. Products are designed for microbiology and clinical chemistry applications and testing procedures, and specialize in parasitology.


Japan • Saitama Tel: (81) 48-280-3055 Web: Produces medical and analytical devices including hemoglobin and bilirubin meters, as well as colorimeters and spectrophotometers.


Apex Biotechnology

Taiwan • Hsinchu Tel: (886) 3-564-1952 Web: E-mail: Manufactures surgical and medical instruments, as well as being involved in the development and production of testing products for blood glucose, cholesterol, hemoglobin, and blood uric acid.

Arista Biologicals

USA • Allentown, PA Tel: (1) 484-223-0309 Web: E-mail:

Designs, develops, manufactures and markets reagents for the rapid diagnostic test industry. Reagents produced are used in rapid tests for pregnancy, drug abuse, infectious diseases, etc. Custom applications include tumor markers and other disease state applications.

Japan • Kyoto Tel: (81) 75-662-8979 Web: Focuses on the production of diabetes testing devices, urinalysis systems, gene analysis devices and other equipment. Established as a leader in the blood glucose monitoring market with over 50 years of experience of innovation in clinical diagnostics.

Arkray, Inc.

USA • Westbrook, ME Tel: (1) 207-854-0867 Web: E-mail: Focuses on improving process productivity and quality by providing easy-to-use systems for validating liquid delivery performance.


Asan Pharmaceutical

Korea • Seoul Tel: (82) 2-3290-5700 Web: E-mail: Offers diagnostic products such as DNA chip and protein chip. The company plans to develop vaccines for HBV, HCV, and also new drugs for hepatitis.

USA • Jacksonville, FL Tel: (1) 818-880-6700 Web: E-mail: Produces CyberLAB, a comprehensive lab management solution that addresses the life cycle of laboratory operations from ordering to reporting and more.


visit us at MedlaB

Stand Z1.d36

Association of Public Health Laboratories

USA • Silver Spring, MD Tel: (1) 240-485-2745 Web: E-mail: Provides laboratory continuing education on a variety of topics, including live, costeffective webinars, and access to CEUs for lab personnel. Japan • Tokyo Tel: (81) 03-3366-0811 Web: Designs and produces scientific instruments such as generators and microprocessor-controlled matching network products.


UK • Kent Tel: (44) 0-208-309-2031 Web: E-mail: Manufactures autoclaves and sterilizers from 33 to 3,000 liters, and decontamination systems for highcontainment laboratories.

Germany • Berlin Tel: (49) 0-30-74-696-509 Web: E-mail: Offers a wide range of reagents and diagnostic kits for detection of human hormones, genetic diseases, tumor markers, and allergens.

Astra Biotech

USA • Manassas, VA Tel: (1) 703-366-3851 Web: E-mail: Manufactures IVD test kits and supplies generic and branded pharmaceuticals, medical disposables, medical, and laboratory equipment, and blood glucose and cholesterol monitoring products.

Atlas Link

AUDIT MicroControls

USA • Eatonton, GA Tel: (1) 866-252-8348 Web: E-mail: Supplies daily quality control and calibration verification/linearity materials to clinical laboratories worldwide.

Autobio Diagnostics

China • Zhengzhou Tel: (86) 371-6798-5313 Web: E-mail: info@ Develops and manufactures clinical diagnostic products including ELISA, chemiluminescence immunoassays, microbiology, and POCT.

USA • Carlsbad, CA Tel: (1) 760-477-2248 Web: E-mail: international@ Provides automated microarray-based multiplexing molecular diagnostic platforms that can be used to LMI-11-18 136

AVE Science & Technology

China • Changsha Tel: (86) 731-8892-5308 Web: E-mail: Specializes in research and development, manufacturing, marketing, and service of medical devices, biological reagents, remote medical diagnosis network, computer software, automatic control devices, medical auxiliary equipments, and more.

Astell Scientific



assess disease signatures with genomic and proteomic markers in the area of genetic disorders, infectious diseases, cancer, and pharmacogenetics.

Awareness Technology

USA • Palm City, FL Tel: (1) 772-283-6540 Web: E-mail: Designs and manufactures semi- and fully automatic biochemistry, ELISA, CLIA, and ISE electrolyte analyzers for small- to mediumsized labs. The company also offers ReQuest immunoassay kits, and Dexall allergy-testing solutions.

UK • Eastleigh, Hampshire Tel: (44) 23-8048-7209 Web: E-mail: Specializes in supplying lab products such as pipettes and liquid handling systems, as well as containers, disposables, and specimen transport packaging.

American Biochemical & Pharmaceuticals

See ad oN paGe 41

Germany • Bürstadt Tel: (49) 6206-6012 Web: E-mail: Manufactures and supplies serology, immunology, urine analysis and ELISA (EIA) instruments for laboratory and hospitals. The company also offers a complete range of Powervision and surgical microscopes for use in hospital and lab industries, as well as universities and schools.

AXIOM Solutions

UK • Crumlin Tel: (44) 0-1495-363000 Web: E-mail: Supplies diagnostic and therapeutic reagents and conjugates, gold and silver labeling of proteins and oligonucleotides, as well as quality control sera for molecular diagnostic tests.

BBI Solutions

USA • Franklin Lakes, NJ Tel: (1) 201-847-6800 Web: Manufactures and sells medical supplies, devices, laboratory equipment, and diagnostic products.

BD Diagnostics

USA • Brea, CA Tel: (1) 714-993-5321 Web: Manufactures biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes.

Beckman Coulter

USA • Wayne, NJ


Bel-Art Products

labMedica International December/2019-January/2020

LabMedica 300

Benchmark Scientific

BioFire Diagnostics

A BioMerieux Company

See ad oN paGe 25

Berthold Technologies

Germany • Bad Wildbad Tel: (49) 7081-177-0 Web: E-mail: Offers a broad line of bioanalytical instruments including gamma counters, luminometers, flurometers, imaging systems, and HPLC detectors.

Bio-Rad Laboratories

USA • Hercules, CA Tel: (1) 510-724-7000 Web: E-mail: ask_customer_ Provides a full range of instrumentation, reagent kits, software and quality control systems to clinical laboratories. Areas of expertise include autoimmune, infectious disease, diabetes monitoring, hemoglobin screening, quality control, HIV, and hepatitis testing.

USA • Ijamsville, MD Tel: (1) 301-874-8888 Web: E-mail: Offers gold sol nanoparticles (10 to 50 OD), gold conjugates, and rapid assay development services, including custom conjugation.

BioAssay Works

China • Hangzhou Tel: (86) 571-8777-4575 Web: E-mail: Focuses on researching and manufacturing high-tech pro-

Bioer Technology


See ad oN paGe 27

Finland • Helsinki Tel: (358) 9-773-861 Web: E-mail: Develops, manufactures and markets diagnostic tests and analysis systems.

Biohit HealthCare

USA • Salt Lake City, UT Tel: (1) 801-736-6354 Web: E-mail: Specializes in the manufacturing, marketing and sales of the FilmArray molecular diagnostics system.

Spain • Llissa d’Amunt Tel: (34) 93-860-90-00 Web: E-mail: Develops and manufactures OEM immunoassays and biomaterials for global IVD companies. The company specializes in infectious disease serology, and offers products that implement different technologies including chemiluminescence.


USA • Edison, NJ Tel: (1) 908-769-5555 Web: E-mail: info@ Specializes in equipment and instrumentation for the life sciences laboratory. Products include dry baths, homogenizers, pipettes, electrophoresis equipment, shakers, rockers, vortexers, and minicentrifuges.

ducts for life science applications including instrumentation, related reagents, disposables, general lab equipment, and temperature baths.

See ad oN paGe 36

France • Maizy Tel: (33) 323 25 15 50 Web: E-mail: Produces reagents and offers a comprehensive range of kits for biochemistry, coagulation and specific proteins. The company also produces polyvalent QC Sera and multicalibrators for biochemistry.


Italy • Santa Margherita di Ala Tel: (39) 0464-357951 Web: E-mail: Manufactures microplates and other articles for ELISA, molecular biology, HTS-TC, and research, with a complete range of surfaces and coatings for all applications.


factures and markets in vitro diagnostics systems used in clinical and industrial applications.

BioPorto Diagnostics

Denmark • Hellerup Tel: (45) 4529-0000 Web: E-mail: Focuses on diagnosis and monitoring of critically ill patients by means of analyses suitable for point-of-care (POC) testing.

BIORON Diagnostics

Germany • Speyer Tel: (49) 6232-29844-0 Web: E-mail: Develops, produces, and markets a wide range of open-system, real-time PCR kits for the detection of pathogens, especially STIs.

BioSampling Systems

France • Cergy-Pontoise Tel: (33) 1-34-30-42-00 Web: E-mail: marketing@ Provides full sample management solutions such as software, automates, readers, accessories, and consumables for pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, and research institutions.

Biosearch Technologies

USA • Petaluma, CA Tel: (1) 415-883-8400 Web: E-mail: Designs and manufactures nucleic acid-based products that accelerate the discovery and application of genomic information. Italy • Cantarana Di Cona Tel: (39) 04-26-302226 Web: E-mail:


Specializes in the production of optical multisample cuvettes and cups, as well as a wide range of disposable labware.

Spain • Barcelona Tel: (34) 93-311-00-00 Web: E-mail: biosystems@ Develops and manufactures reagents and instruments for clinical analysis.


Biotech Company Nanchang

China • Nanchang Tel: (86) 791-8816-8831 Web: E-mail: Provides a range of diagnostic instruments and reagents for medical and clinical applications.

Biotecnica Instruments

Italy • Rome Tel: (39) 6-411-2316 Web: E-mail: Designs and manufactures standard and OEM clinical chemistry equipment and relevant reagent products intended for private and state clinical laboratories including photometers, automatic analyzers, and ion selective analyzers.

BioTek Instruments

USA • Winooski, VT Tel: (1) 802-655-4740 Web: E-mail: Developer and supplier of microplate instrumentation and software solutions used in drug discovery, genomics and proteomics, and life science research.

Biotron Diagnostics

USA • Hemet, CA Tel: (1) 951-658-7766 Web: E-mail: sales@ Develops and manufactures a complete line of kits and reagents for IVD.

USA • Bellport, NY Tel: (1) 631-589-1118 Web: E-mail: Provides reconditioned laboratory equipment as an alternative to purchasing new. Areas of specialty include blood gas, electrolyte, chemistry and hematology, with products such as consumables, parts, reagents, and technical service also available.

Block Scientific

Blue Cross Bio-Medical

China • Beijing Tel: (86) 10-6975-6015 Web: E-mail: Manufactures in vitro rapid test kits. Main products include the test strips and cassettes for fertility, hepatitis B&C, drugs of abuse, infectious diseases, tumor marker, and sexually transmitted diseases.

Sweden • Spanga Tel: (46) 8-7447700 Web: E-mail: Specializes in hematology diagnostics, and developed the very first European blood cell counter. The company’s products include instruments, reagents, calibrators and controls that are used by healthcare providers around the world and are currently sold in more than 100 countries.

Boule Medical

Bühlmann Laboratories

Switzerland • Schönenbuch Tel: (41) 61-487-12-12 Web: E-mail:

Biomedical Polymers

Italy • Rome Tel: (39) 6-907-3666 Web: E-mail: Designs, manufactures, and distributes clinical chemistry analyzers and relative reagents worldwide.

BPC BioSed

Germany • Wertheim Tel: (49) 9342-808-0 Web: E-mail: Develops, produces and supplies measuring and dispensing instruments. Product applications include chemistry, medicine, pharmacy and biotechniques.


USA • El Cajon, CA Tel: (1) 619-660-6162 Web: E-mail: Specializes in the custom design of immunoassays including ELISA, ultra-sensitive Chemiluminescence ELISA, RIA, and assays for multiplexing platforms. The company also offers products for in vitro research such as endocrine markers, cardiac markers, cancer markers, drugs of abuse, infectious disease, and autoimmune markers.


Italy • Parma Tel: (39) 05-21-273274 Web: E-mail: Focuses on supplying effective and efficient diagnostic systems that are innovative, fast and simple to use, to operators in the medical, pharmaceutical, wellness and beauty sectors.


CANDOR Bioscience

Germany • Wangen

MedlaB Stand Z6.F44

USA • Irvine, CA Tel: (1) 949-645-2111 Web: E-mail: Develops, manufactures, and sells products designed to detect diseases in the areas of cancer, cardiology, fertility, gastroenterology, diabetes, allergy, and infectious diseases.



labMedica International December/2019-January/2020

See ad oN paGe 37

visit us at

USA • Sterling, MA Tel: (1) 978-632-2555 Web: E-mail: sales@ Manufactures plastic consumables for research and medical diagnostic laboratories.

France • Marcy l'Etoile Tel: (33) 4-7887-2000 Web: Designs, develops, manu-

Develops, manufactures and sells in-vitro diagnostic assays, including automated solutions and rapid tests.

Tel: (1) 973-694-0500 Web: E-mail: Manufactures and distributes over 3,500 items from safety wash bottles to fume hoods, distributed under well known brand names such as Scienceware, PLUM, Sterileware, Magic Touch, Secador and H-B Instrument.


LMI-01-20 137

LabMedica 300 Tel: (49) 7522-795270 Web: E-mail: Develops, produces, and distributes over 50 different products for immunoassays including optimizers, blockers, stabilizers, and buffer solutions.

Canterbury Scientific

New Zealand • Christchurch Tel: (64) 3-343-3345 Web: E-mail: info@ Manufactures freeze-dried and ready-to-use liquid quality hemoglobin controls for hematology and biochemistry diagnostic tests. Products are used for monitoring blood tests and calibrating equipment and processors on in vitro diagnostic analyzers.

Caretium Medical Instruments

China • Shenzhen Tel: (86) 755-2527-3885 Web: E-mail: Develops and manufactures products that include biochemistry analyzers, microplate readers, electrolyte analyzers, and erythrosedimentation rate analyzers. See ad oN paGe 14

India • New Delhi Tel: (91) 11-4153-9602 Web:

Carewell Biotech

Carl Zeiss MicroImaging

Germany • Jena Tel: (49) 3641-64-3161 Web: E-mail: Specializes in the optical and optoelectronic industries. The company products for semiconductor and optoelectronic technology, life sciences, healthcare, and eye care.

Carolina Liquid Chemistries

USA • Greensboro, NC Tel: (1) 336-722-8910 Web: E-mail: Manufactures bar-coded chemistry reagents, parts, supplies, and service for use on Beckman Synchron and the Olympus AU series of instruments. Colombia • Bogota Tel: (57) 1-805-28-49 Web: E-mail: Manufactures and merchandizes reagents for in vitro diagnositcs for use in clinical laboratories and blood banks.


USA • Westlake Village, CA Tel: (1) 805 2220877 Web: E-mail: IVD-manufacturer based in California, focused on novel-clinical diagnostics for labs and physicians to meet patient care needs. Produces innovative solutions

CDG Biotech Corp

using leading-edge automation in exclusive design that help labs reduce critical labor costs while improving response time and the quality of results.

Sweden • Lund Tel: (46) 46-286-4400 Web: E-mail: Develops systems for the routine analysis of blood and other fluids, which provide critical results used in the diagnosis of a variety of diseases such as infection and cancer.


Germany • Memmingen Tel: (49) 89-2000-11074 Web: E-mail: Offers systems solutions for online analysis of living cells, including services such as research and development, production, and maintenance of cell-based assays.


USA • Sunnyvale, CA Tel: (1) 408-541-4191 Web: E-mail: cepheid@ Specializes in clinical molecular diagnostics assays with real-time PCR detection, and focuses on research and development.


Spain • San Mateo de Gallego Tel: (34) 976-520-354 Web: E-mail: Develops and manufactures IVD diagnostic products and real-time PCR diagnostic products for human applications.

Certest Biotec

Chema Diagnostica

Italy • Monsano Tel: (39) 731-605-064 Web: E-mail: Develops and manufac-

tures a wide range of liquid stable reagents for the clinical chemistry and immunochemistry industries.

Chembio Diagnostic Systems

USA • Medford, NY Tel: (1) 631-924-1135 Web: E-mail: Develops, manufactures, and markets rapid tests for the detection of HIV, TB, Chagas, and other infectious diseases.

China • Beijing Tel: (86) 10 5871 7511 Web: E-mail: Develops diagnostic reagents covering chemiluminescence assays and clinical chemistry assays. The company also offers commercial testing services for infectious diseases, tumor, thyroid, diabetes, fertility, and liver fibrosis.

Chemclin Biotech

Germany • Nordhausen Tel: (49) 0-3631-65242-0 Web: E-mail: Develops and manufactures laboratory liquid handling instruments. Products include pipettes, pipette tips, and microplate washers.


E-mail: Designs, manufactures, and markets diagnostic products such as electrolyte analyzers and blood glucose monitoring systems in several countries under OEM brands.

See ad oN paGe 3

China • Shanghai Tel: (86) 21-6812-9666 Web: E-mail: international@ Specializes in the development, manufacture and marketing point-of-care (POC) in vitro immunodiagnostic rapid tests for the detection and management of pregnancy, ovulation fertility, infectious diseases, cancers, drugs of abuse, myocardial tissue damage and the onset of menopause. Sample formats include test strips, cassettes, midstream, and cups.

Chemtron Biotech

Chromsystems Instruments & Chemicals Germany • Munich

Tel: (49) 89-18930-0 Web: Offers an easier method for routine clinical diagnostic procedures with simple applications.

Italy • Milan Tel: (39) 02-5681-4413 Web: E-mail: Develops products for in vitro diagnostics with particular attention to the detection of viral, bacteria, and protozoa infections, genetic mutations, and oncological diseases. Products available include ready-to-use diagnostic kits that are userfriendly for routine diagnostic laboratories.


Copan Diagnostics

USA • Murrieta, CA Tel: (1) 951-696-6957 Web: E-mail: Manufactures and distributes laboratory products including transfer pipettes, TOA caps, and autoanalyzer cups.

USA • Broomfield, CO Tel: (1) 303-457-4345 Web: E-mail: Develops, manufactures and markets clinical laboratory diagnostic products. The REAADS product range of ELISA-based assays focuses on the diagnosis and management of selected autoimmune disorders, vascular disease, and thrombotic tendency using immunological technology.


Coris BioConcept

Belgium • Gembloux Tel: (32) 81-719-917 Web: E-mail: Develops, manufactures, and markets a wide range of rapid antigen tests for detection of enteric, gastric, and respiratory diseases.

Poland • Lomianki Tel: (48) 22-751-79-10 Web: E-mail: Designs and manufactures a range of products for clinical chemistry, hematology, electrophoresis, coagulation, and specific proteins.


China • Shenzhen Tel: (86) 755-8633-0432 Web: E-mail: Manufactures diagnostic analyzers, including equipment for electrolytes analysis, blood gas analysis, and TCO2 analysis.

Cornley Hi-Tech

India • Chennai Tel: (91) 44-2499-3989 Web: E-mail: Specializes in lab products that focus on clinical chemistry, hematology and coag-

CPC Diagnostics

ulation, immunodiagnostics, molecular diagnostics and research, and pre-analytical automation.

Crony Instruments

Italy • Rome Tel: (39) 6-4396432 Web: E-mail: Markets and sells automatic and semi-automatic analyzers, and develops and produces analyzers on an OEM basis.

USA • Poway, CA Tel: (1) 858-457-8698 Web: E-mail: Develops and manufactures innovative rapid tests, ELISA kits, and external controls.

CTK Biotech

UK • Cambridge Tel: (44) 1223-294048 Web: E-mail: Develops and manufactures FISH probes for use in both routine cytogenetics and in the analysis and classification of various types of cancer.


Spain • Salamanca Tel: (34) 923-125-067 Web: E-mail: Designs and develops new reagents, software, and techniques that offer solutions in the field of flow cytometry.


Belgium • Mons Tel: (32) 65-84-18-88 Web: E-mail: Develops diagnostic products for autoimmunity and gastroenterology, including the BlueDot and BlueWell product lines, and along with liquid substrates and stabilizers.


China • Guangzhou Tel: (86) 20-3229-0789 Web: E-mail: marketing@ Produces and services IVD products, including PCR, TRF, ELISA and RAPID diagnostic kits and equipment.

Da An Gene

Italy • Palombara Sabina Tel: (39) 0774-637070 Web: E-mail: Designs and manufactures analyzers and automated equipment. Main fields of application are immunoenzymatic, immunofluorescence, and clinical chemistry.


Italy • Arcore Tel: (39) 039-617670 Web: E-mail: Manufactures blood bank equipment, laboratory refrigerators, and molecular


labMedica International December/2019-January/2020


LabMedica 300 biology devices. Company also distributes slide stainers, osometers, cystic fibrosis diagnostic devices, and liquid nitrogen containers.

Japan • Tokyo Tel: (81) 3-6214-3236 Web: E-mail: seiken@ Develops, manufactures, and distributes in vitro diagnostic reagents and vaccines. Top export products include direct and automatable HDL and LDL reagents, latex-enhanced serum protein tests for hsCRP, rheumatoid factor, myglobin, ferritin and others, as well as rapid diagnostic test kits for MRSA, E. coli O157, parvo B19, Norwalk-like and influenza viruses.

Denka Seiken

Korea • Gimhae Tel: (82) 55-346-1882 Web: E-mail: Researches, develops and manufactures in vitro diagnostic products for urinalysis, including the Cybow series of products.


DIA.PRO Diagnostic Bioprobes

Italy • Milan Tel: (39) 02-2700-7161 Web: E-mail: Develops and manufactures in vitro immunoassays for the diagnosis of infectious diseases. France • Lille



DiagCor Life Science Limited

China • Hong Kong Tel: (852) 2147-4088 Web: E-mail: Dedicated solely to the business of MDx, the company is a global leader in flowthrough hybridization technology, offering a wide range of products, solutions and services in the area of RNA and DNA rapid analysis.

Diagnostic Automation / Cortez Diagnostics

USA • Calabasas, CA Tel: (1) 818-591-3030 Web: E-mail: Manufactures and supplies rapid tests, ELISA, IFA, chemiluminescence, and serology kits.

Hungary • Budapest Tel: (36) 1-369-07-39 Web: E-mail: business@ Develops and markets biochemistry reagents and immunology kits, with applications for open analyzers.


France • Asnières sur Seine Tel: (33) 1-4688-2020 Web: E-mail: Offers a complete system of

Diagnostica Stago

labMedica International December/2019-January/2020

hemostasis instrumentation and optimized reagent kits for research, as well as for routine analysis.

Hungary • Budapest Tel: (36) 1-369-6500 Web: E-mail: Produces hematology reagents and develops reagents for new hematology analyzers that appear on the market.


Austria • Wiener Neudorf Tel: (43) 2236-660910-0 Web: E-mail: Manufactures and distributes diagnostics and laboratory equipment, supplying a range of products, based on clinical chemistry reagents, immunological reagents, and coagulation reagents.


An Erba Mannheim Company


USA • Miami, FL Tel:(1) 305-324-2300 Web: E-mail: Focuses on the development of integrated instrument and reagent systems for both autoimmune and infectious disease detection. Italy • Perugia Tel: (39) 0742-24-851 Web: E-mail: Focuses on the manufacture of ELISA immunoassay kits, as well as offering a wide range of analytes for various applications.


Diamond Diagnostics

USA • Holliston, MA Tel: (1) 508-429-0450 Web: Specializes in refurbished


e-”quipment for chemistry, immunology, hematology, coagulation, microbiology, flow cytometry, and blood gases. The company also reagents, manufactures electrodes, tubing, probes, and QC materials for use in a wide range of brands, as well as the SmartLyte, ProLyte, and CareLyte lines of electrolyte analyzers. E-mail: Develops, manufactures, and distributes diagnostic systems for clinical chemistry and immunoturbidimetry. Supplies high-quality reagents for routine and special diagnostics, as well as automated analyzers for laboratory and POC.



Korea • Seoul Tel: (82) 2912-7933 Web: Develops and manufactures real-time PCR kits for clinical chemistry and POC testing.

Italy • Saluggia Tel: (39) 0161-4871 Web: E-mail: Develops and manufactures reagents for in vitro diagnostics. Areas of specialty include infectious disease, hepatitis, endocrinology, bone and mineral metabolism, cancer, brain injury, cardiac, therapeutic drug monitoring and autoimmunity.


DIAsource ImmunoAssays

Belgium • Louvain-La-Neuve Tel: (32) 10-84-99-11 Web: E-mail: customer.service@ Develops, manufactures, and markets clinical diagnostic products that focus on endocrinology and infectious diseases.

DiaSys Diagnostic Systems

Germany • Holzheim Tel: (49) 6432-9146-0 Web:

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Spain • Barcelona Tel: (34) 93-699-5000 Web: E-mail: Manufactures a range of containers and disposables, along with pipettes and liquid handling systems.


Tel: (33) 3-20-96-53-53 Web: E-mail: Specializes in the transfusion field, and produces its own immunohematology cells lines, monoclonal antibodies and develops the reagents associated to E.M. technology, microplates, and manual techniques.

See ad oN paGe 9

Hungary • Budapest Tel: (36) 1-436-9800 Web: E-mail: Specializes in the development, manufacturing and marketing of hematology analyzers, reagents, and control material, plus clinical chemistry analyzers, reagents, and controls.

Diazyme Laboratories

USA • Poway, CA Tel: (1) 858-455-4768 Web: E-mail: Develops test kits and reagents for the diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, and electrolytes.

Diesse Diagnostica Senese

Italy • Siena Tel: (39) 05-77-319560 Web: E-mail: Products include: Erythrocyte sedimentation rate test; modular instrument for bacteriological screening and isolation of microorganisms in urine and stool; complete line of Elisa test kits, which offer common reagents; multiparametric analyzer for infectious diseases and autoimmunity; agglutination tests for CRP, RF, ASO, Febrile Antiges and complement fixation tests for manual procedure.

Argentina • Buenos Aires Tel: (54) 11-4709-7707 Web: E-mail: Develops and produces medical devices and IVD products, including analyzers, software, electrodes, and consumables.


China • Changchun Tel: (86) 431-8508-3721 Web: E-mail: Specializes in R&D and manufacturing of products for urine analyzers, including urine strips.

Dirui Industrial

USA • Springfield, NJ Tel: (1) 973-564-7555 Web: E-mail: orders@ Provides complete range of products and services to the diagnostics and cardiologyrelated medical community. The company is constantly looking towards the future in order to continue to produce and distribute the highestquality diagnostic products in clinical chemistry, immunology and microbiology that are cutting edge, easyto-use and effective.

DRG International

Canada • Ottawa, ON Tel: (1) 613-723-5757 Web: E-mail: Develops products that enable easy collection, stabilization, transportation, and preparation of DNA and RNA samples.

DNA Genotek

China • Beijing Tel: (86) 10-6049-8800 Web: E-mail: Manufactures laboratory instruments for researchers in both the scientific and clinical fields, focusing on two

DLAB Scientific

LabMedica 300 product lines: liquid-handling devices – including mechanical electronic and autoclavable pipettes, and pipetting aids – and diagnostic instruments, such as erythrocyte sedimentation rate analyzers.

Drucker Diagnostics

Germany • Mainz Tel: 49 (0) 6131-1445 4131 Web: E-mail: sales@ DWK Life Sciences brings together three leading manufacturers of precision glassware, laboratory consumables and specialty products for life sciences, in the globally recognized brands DURAN, WHEATON and KIMBLE. Offers customers a complete, comprehensive line of purpose-built glassware, plastics, and fused-material-based containers for research, diagnostics, and specialty pharmaceuticals markets.

DWK Life Sciences

Dynex Technologies

USA • Chantilly, VA Tel: (1) 703-631-7800 Web: E-mail: customerservice@ Designs and manufactures innovative ELISA instruments, including the Agility automated system with SmartKit technology. As a leader in automated microplate technology, the company offers the new Multiplier with SmartPLEX technology.

USA • North Berwick, ME Tel: (1) 207-676-7639 Web: E-mail: Manufactures and supplies high-quality antigens, antibodies, and specialized immunoassay reagents for the diagnostic manufacturing industry. Products include SeaBlock fish plasma blocking reagents, as well as cardiac markers, DOA, hormones, infectious diseases, serum proteins, and tumor markers.

EastCoast Bio

UK • High Wycombe Tel: (44) 0-203-567-7300 Web: E-mail: Specializes in providing purified laboratory water for research and testing, healthcare, and clinical diagnostics applications.

France • Paris Tel: (33) 0-1-41-45-07-10 Web: E-mail: Offers a range of products for in vitro diagnostics in clinical chemistry, hemostasis, microbiology, immunology, and electrophoresis.

ELITech Group

USA • Port Matilda, PA Tel: (1) 814-692-7661 Web: E-mail: sales@ Develops, manufactures, and markets a wide range of centrifuges for use in medical, research, educational, and industrial laboratories.

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ELGA LabWater

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Emperor Electronic Technology

China • Shenzhen Tel: (86) 755-3689-9033 Web: E-mail: business@ Specializes in the development, manufacture, and distribution of in vitro devices including chemistry analyzers, urine analyzers, and immunology analyzers.

EKF Diagnostics

UK • Cardiff Tel: (44) 29-20-710570 Web: E-mail: info@ Focuses on the POC market with over 80,000 hemoglobin, HbA1c, glucose and

Erba Diagnostics Mannheim

Germany • Mannheim Tel: (49) 621-8799770 Web: E-mail: sales@

visit us at

Provides a range of analyzers and reagents. Products available focus on clinical chemistry, immunology, hematology, coagulation, critical care, urine analysis, diabetes monitoring, autoimmune and infectious disease monitoring, and microbiology.

See ad oN paGe 35

China • Shenzhen Tel: (86) 0755-2600-8015 Web: E-mail: Specializes in the manufacture and sales of products that include in vitro diagnostic medical devices and home ventilators.

Korea • Gunpo Tel: (82) 31-427-8450 Web: E-mail: Develops multi-markers for people with diabetes and tuberculosis. The Epithod 616 system is the first POC analyzer for entire stages of diabetes care to measure both Glycated Albumin and HbA1c.


Dymind Biotech

lactate analyzers in regular use in more than 100 countries running more than 70m tests every year. The company is also a global manufacturer of central lab products including Stanbio chemistry reagents.

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Germany • Hamburg Tel: (49) 4053-8010 Web: E-mail: Develops, manufactures, and distributes systems comprising instruments, consumables, and reagents. The company focuses on two areas: bio tools – including pipettes, dispensers, and centrifuges and consumables such as test tubes and pipette tips; and molecular technologies – which includes instruments and systems for cell manipulation, automatic devices for highthroughput screening (HTS), complete systems for DNA multiplication, nucleic acid purification kits, and biochips.


Czech Republic • Brno Tel: (42) 517-077-111 Web: E-mail: Develops, manufactures, and markets products for urine analysis, clinical chemistry, and bacterial identification.

Erba Lachema

Singapore • Singapore Tel: (65) 6542-0833 Web: E-mail: Delivers controlled environment, lab and cleanroom equipment solutions to the clinical, life science, research, and industrial laboratory community.

Esco Micro

Portugal • Santa Maria da Feira Tel: (351) 256-330350 Web: E-mail: Develops, manufactures and distributes a wide range of hospital, clinical lab, safety and hygienic products. The company created the Toplabs catalog, which includes quality products such as TopStar glucose solution, ZeroDNA and Mycoplasmafree.



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Italy • Milan Tel: (39) 02-38195-1 Web: E-mail: Specializes in cell biology, cytogenetics, genomics, and proteomics, providing the clinical chemistry industry



LMI-18-10 140

Germany • Lübeck Tel: (49) 451 58 55 0 Web: E-mail: Designs and manufactures products for autoimmune and infection diagnostics, allergology and molecular diagnostics. The product range includes indirect immunofluorescence, ELISA, immunoblot, radioimmunoassay and molecular genetic test systems, as well as state-of-the-art instruments, software and automation systems.


Italy • Trieste Tel: (39) 040 8997 1 Web: E-mail: Develops and manufactures diagnostic medical devices for the in vitro diagnosis of Celiac diseases, inflammatory bowel disease, Helicobacter pylori, and infectious diseases.


Netherlands • Ede Tel: (31) 318-695-777 Web: E-mail: Provides QC materials to the diagnostic laboratory market, EQA/PT programs, standardization bodies, hospital labs, and POC.


Express Diagnostics International

USA • Blue Earth, MN Tel: (1) 507-526-3951 Web: E-mail: Manufactures and distributes DrugCheck onsite urine and saliva screening devices for the detection of over 50 DOA and cutoffs, as well as a growing catalog of rapid alcohol screening and health diagnostics devices.

Feather Safety Razor

Japan • Osaka Tel: (81) 6-6458-1638 Web: E-mail: Manufactures razor blades with technology and development capabilities centering on ultra-precision metal processing. Manufactures medical products for surgery, dermatology, ophthalmology and other areas, including products such as micro surgical blades, scalpels, ophthalmic knives, blade scissors and more.

France • Les Ulis Tel: (33) 01-69 79 64 80 Web: E-mail: Develops, produces and sells a complete range of reagents and biochemicals for the diagnostic and research markets.


with instruments, reagents and kits, as well as lab equipment and supplies for contamination control.

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USA • Syosset, NY Tel: (1) 516-922-6050 Web: E-mail: Manufactures metering pumps and dispensers with a valveless, positive displacement design.

Fluid Metering

UK • Salisbury Tel: (44) 1980-612-058 Web: E-mail: Develops and manufactures ambient storage molecular biology reagents, assays, and kits for use in genetic identification, infectious disease detection, veterinary pathology, and applied R&D.


Fortress Diagnostics

UK • Antrim Tel: (44) (0) 2894-487676 Web: E-mail: info@ Develops and manufactures a portfolio of POC and clinical diagnostic test kits across a spectrum of disciplines. Company products can be found in clinical chemistry, immunology, hematology and serological laboratories, as well as in blood banks, in more than 100 international markets.

China • Shanghai Tel: (86) 21-6076-5888 Web: E-mail: diagnostics@ Develops, markets, and distributes in vitro diagnostic products including real-time PCR analyzers, and a range of genotyping kits.

Fosun Diagnostics

FUJIFILM Wako Pure Chemical Corporation

Japan • Osaka Tel: (81) 6-6203-3741 Web: Develops and manufactures products for three areas: laboratory chemicals, specialty chemicals, and diagnostic reagents.

Fujirebio Diagnostics

USA • Malvern, PA Tel: (1) 610-240-3800 Web: Manufactures monoclonal antibodies designed to detect a variety of tumor markers. These antibodies have also been used to help develop a menu of in vitro diagnostic tests.

USA • Grass Valley, CA Tel: (1) 530-273-8888 Web: E-mail: liquidhandling.tcs@ Manufactures subsystems for clinical and biotechnology automated instruments.

Gardner Denver

Taiwan • Taipei Tel: (886) 2-2553-1456 Web: E-mail: gemmy888@ Manufactures laboratory equipment, suction units, autoclaves/sterilizers, and ENT treatment units.

Gemmy Industrial

General Biologicals

Taiwan • Hsinchu City Tel: (886) 3-577-9221

labMedica International December/2019-January/2020


LabMedica 300 Web: E-mail: Develops and manufactures high-quality IVD and pharmaceutical products for doctors to make clinical decisions in the area of hepatitis, tumor markers, retrovirus, fertility, thyroid and steroids. In general consumables, the company also provides an anti-bacterial peptide in areas of pharmaceutical, cosmetics and oral products.

GeneReach Biotechnology

GenMark Diagnostics

USA • Carlsbad, CA Tel: (1) 760-448-4300 Web: E-mail: Provides cost-effective molecular diagnostic technologies and tools that enable a broader range of hospitals and laboratories to offer molecular diagnostic services for improved patient care.

China • Shenzhen Tel: (86) 755-2683-5560 Web: E-mail: international@ Specializes in developing, manufacturing and marketing IVD equipment and reagents. Product range covers immunoassay, chemistry, hematology, urinalysis, and point-of-care, as well as associated reagents.

Genrui Biotech

Getein Biotechnology

China • Nanjing Tel: (86) 25-6856-8594 Web: E-mail: Develops and manufactures a range of rapid test kits for disease detection, as well as quantitative immunoassay analyzers.

Globe Scientific

USA • Mahwah, NJ Tel: (1) 201-599-1400 Web: E-mail: Specializes in high quality laboratory plastic and glassware items designed for use in the research, clinical, industrial, and specialty mar-



Grifols International

Italy • Arcore Tel: (39) 039 6882252 Web: E-mail: Offers OTC diagnostic tests for home- and self-testing. Products also include tests for professional use including ELISA tests, biochemistry kits, and instruments.

Korea • Seoul Tel: (82) 2-2104-0470 Web: E-mail: Manufactures products for POCT, hematology, coagulation, and blood bank, including safety and general lancets, along with containers and disposables.


Goldsite Diagnostics

China • Shenzhen Tel: (86) 755-2689-0807 Web: E-mail: export@ Specializes in producing serum protein assaying instruments and reagents, including Nephstar and Nephstar Plus protein analysis system, along with up to 30 kits for determining specific proteins.

Gongdong Medical Technology

China • Taizhou Tel: (86) 576-8411-5678 Web: E-mail: Manufactures and distributes disposable medical and lab consumables.

Korea • Cheonan Tel: (82) 41-551-0600 Web: E-mail: gcms.overseas@ Designs and manufactures blood diagnostics products including POC equipment for measuring blood glucose, hemoglobin, lactate, HbA1c, CRP, and hematocrit.

Green Cross Medis

Greiner Bio-One International

Austria • Kremsmunster Tel: (43) 7583-6791-0 Web: E-mail: The Preanalytics division develops, manufactures and distributes venous blood collection devices for hospitals, laboratories and blood banks. The Bioscience division manufactures products for the biomedical industry, including pipettes, PCR plates, reaction tubes, analyzer cups, and cell separation media.

Germany • Bahlingen Tel: (49) 76-6391-490 Web: E-mail: info@ Specializes in developing, manufacturing and marketing a range of clinical diag-

Greiner Diagnostic

labMedica International December/2019-January/2020

Spain • Barcelona Tel: (34) 935-712-200 Web: Researches, develops, manufactures and markets plasma derivatives, IV therapy, enteral nutrition, diagnostic systems, and medical materials.

Haier Medical and Laboratory Products

China • Qingdao Tel: (86) 532-8893-7380 Web: E-mail: Specializes in the design, manufacturing, and marketing of a range of scientific products, such as low-temperature freezers, for various lab applications.

systems, and plasma thawing systems. A complete line of centrifuges and accessories is also available.

Germany • Sondheim vor der Rhön Tel: (49) 9779-808-0 Web: E-mail: Offers products for blood tests and urine analysis, microscopic and staining utensils, liquid handling, water treatment, measuring glass instruments, as well as general lab apparatus, and hydrometers and thermometers.

Hecht - Assistent

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USA • Independence, MO Tel: (1) 816-796-2900


Web: E-mail: Designs and manufactures laboratory hoods, furniture, enclosures, and clean labs for a range of scientific applications. Sweden • Angelholm Tel: (46) 77-570-02-10 Web: E-mail: Develops, produces, and markets products for pointof-care testing. The company’s leading products measure hemoglobin and glucose in whole blood and albumin in urine.


USA • Irwindale, CA Tel: (1) 626-443-8480 Web: E-mail: Manufactures the Hemosure Immunological Fecal


Occult Blood test (IFOBT) that offers high sensitivity and high specificity, and is easily performed in physician offices, hospitals, and labs.

Germany • Tuttlingen Tel: (49) 7461-705-0 Web: E-mail: Provides customers with a complete line of centrifuges. Product applications include clinical chemistry, hematology, cytology and hystology. Centrifuge varieties include microliter, hematocrit, benchtop, underbench, floor-standing, blood bank, robotic centrifuges, refrigerated and nonrefrigerated and cell washers.


HiMedia Laboratories

India • Mumbai Tel: (91) 22-6147-1919 Web:

Korea • Cheongju Tel: (82) 43-229-6200 Web: E-mail: Develops, produces, and distributes products for clinical chemistry including an automatic self-balancing centrifuge.


Korea • Seongnam Tel: (82) 31-682-2100 Web: E-mail: Specializes in clinical chemistry and immunology products for the fields of biochemistry and immunity.


China • Shenzhen Tel: (86) 0755 25821365 Web: E-mail: Dedicated to the research, development, sale and service of clinical diagnosis products, which include liquid handling systems, microplate washers and readers, specific protein analysis systems, full automatic CRP analyzers and reagents.


Hungary • Budapest Tel: (36) 1-465-01-24 Web: E-mail: Focuses on HPV diagnostics research, offering a real-time PCR test that detects all 14 high-risk HPV types in one reaction.


nostic assays and kits including niche products like oxalate test, and pyruvate kinase deficiency test.

Taiwan • Taichung City Tel: (886) 4-2463-9869 Web: E-mail: Manufactures and markets products for applied nucleic acid detection technology, including equipment and reagents, as well as diagnostic kits for the point-ofcare market.

kets. The company also provides custom kit assembly, private label, and custom molding services.

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Helena Laboratories

USA • Beaumont, TX Tel: (1) 409-842-3714 Web: E-mail: Provides specialized, sensitive bedside hemostasis diagnostics for intraoperative platelet aggregation and heparin monitoring. USA • Noblesville, IN Tel: (1) 317-773-9073 Web: E-mail: Manufactures and distributes lab equipment and temperature-controlled products. Blood bank products include refrigerators, freezers, platelet storage



LMI-01-20 141

LabMedica 300 E-mail: Manufactures high quality culture media for microbiology, and offers a complete range of chromogenic and HiVeg media products.

Hitachi (Healthcare Business Unit)

Hongqi Optical Instrument Technology

China • Guangzhou Tel: (82) 020-8207-0977 Web: E-mail: Specializes in lab instruments, analyzers, rapid tests, kits and consumables for cervical cancer diagnosis, as well as other diagnostic fields.

France • Montpellier Tel: (33) 4 67 14 15 16 Web: Produces hematology and clinical chemistry analyzers, offering small instruments equipped with features for accuracy and reliability.

Horiba Medical

Horron XLH Medical

China • Shenzhen Tel: (86) 755-2685-5736 Web: E-mail: Specializes in the development and marketing of products for in vitro diagnostics, including a wide range of analyzers, plate washers, and reagents.

Poland • Warsaw Tel: (48) 22-492-19-00 Web: E-mail: Specializes in the production of laboratory and medical products including single-channel variable-volume pipettes, multichannel pipettes, fixed-volume pipettes, electronic pipetting controllers, and manual dispensers.


Human Diagnostics

Germany • Wiesbaden Tel: (49) 6122-9988-0 Web:

USA • Garden Grove, CA Tel: (49) 0561 8167000-0 Web: E-mail: Develops, manufactures and markets automated instruments and reagent systems. The company also offers a line of urinalysis controls and disposable products under the Kova brand.

Hycor Biomedical

Finland • Turku Tel: (358) 2 512 0900 Web: E-mail: Offers innovative solutions for assay development and research applications by providing high-quality immunological reagents for cardiac markers, Troponin I and Troponin T, infectious disease antibodies, and autoimmune disease reagents.


USA • Minneapolis, MN Tel: (1) 763-780-2955 Web: E-mail: Provides high-quality laboratory reagent assays for research and clinical testing in various areas including autoimmunity, endocrinology, infectious disease, oncology and neuroscience. Products include ELISA kits, RIA kits, chemiluminescent diagnostic and research tools, antibodies and proteins.


iCubio Biomedical Technology

China • Shenzhen Tel: (86) 755-2661-0931 Web: E-mail: Develops and markets lab inspection equipment, including biochemistry analyzers.

USA • Norcross, GA Tel: (1) 770-441-2051 Web: E-mail: Develops and manufactures products used by hospital blood banks, clinical laboratories, and blood donor centers to detect and identify certain properties of human blood prior to patient transfusion.

Immucor Gamma

Immuno Concepts

USA • Sacramento, CA Tel: (1) 916-363-2649 Web: Produces diagnostic test kits for autoimmune diseases including slide as-

Immunodiagnostic Systems

UK • Boldon, Tyne and Wear Tel: (44) 191-519-0660 Web: E-mail: Specializes in immunoassays and creates tools to aid in the diagnosis of diseases of bone and calcium dysfunction such as osteoporosis, osteomalacia and Paget's disease. The company also monitors responses to therapy and studies the fundamental mechanisms of bone disorders. The flagship products of the company are kits for the determination of Vitamin D in human serum. Germany • Bensheim Tel: (49) 6251 701 900 Web: E-mail: info@ Develops innovative immunoassays and other analytical methods for routine testing and research, with a product portfolio that includes a broad range of antibodies and antigens. Company focuses on providing effective tools for prevention, differential diagnosis and therapy monitoring in the areas of gastroenterology, cardiovascular diseases, disorders of the skeletal system and oxidative stress.


Korea • Cheonan Tel: (82) 41-415-2363 Web: E-mail: Develops diagnostic and analytical instruments for medical purposes, as well as providing related services and solutions, and focuses on MEMS, bioengineering, and Lab-on-a-chip techniques.


USA • San Diego, CA Tel: (1) 858-586-9900 Web: E-mail: Focuses on autoimmune disease diagnostics and offers autoimmune testing reagents. The autoimmune product groups include kits and components for testing for connective tissue disease, coagulation, gastrointestinal disorders, vasculitis, endocrine, autoimmune liver disease, and related infectious disease.

Inova Diagnostics

Instrumentation Laboratory

USA • Bedford, MA Tel: (1) 781-861-0710 Web: instrumentation E-mail: customerservice@ Specializes in innovative hemostasis and acute care

IVD testing solutions such as the new GEM Premier 5000 system with iQM2; new GEMweb Plus 500 custom connectivity; GEM Premier 4000/3500 systems; ACL TOP Family 50 Series systems; HemoCell specialized lab automation; HemoHub intelligent data manager; ACL AcuStar system and HemosIL assays. Recent TEM/Accriva acquisitions expanded the product portfolio with ROTEM patient blood management; Hemochron; VerifyNow and Avoximeter systems. See ad oN paGe 17

Institute of Isotopes

Hungary • Budapest Tel: (36) 1-395-9081 Web: E-mail: Develops and manufactures radioactive isotopes, as well as immunoassay kits, for clinical and research laboratory use.

China • Xiamen Tel: (86) 592-680-7100 Web: E-mail: intecproducts@ Specializes in R&D, production and distribution of in vitro diagnostic reagents. Products available focus on infectious disease tests, ELISA, PCR methods, drugs of abuse, fertility and tumor marker. Recently added to the product line is a diabetes monitoring system and a rapid test reader.

InTec Products

International ImmunoDiagnostics

USA • Foster City, CA Tel: (1) 650-345-9518 Web: E-mail: contact@ Offers EIA microwell diagnostic tests, as well as onestep membrane quick screen tests.

Australia • Melbourne Tel: (61) 3 9192 6000 Web: E-mail: Designs and manufactures products, instruments, and custom automation services to in vitro diagnostics, medical devices, life sciences, drug discovery, and pharmaceutical companies.


Netherlands • Groningen Tel: (31) 50-575-7000 Web: E-mail: Supplies a range of products for perinatal diagnostics, transplantation-related diagnostics, and routine flow cytometry.

IQ Products

Japan • Tokyo Tel: (81) 3-3254-2935 Web: Manufactures high-purity metering pumps, chemical delivery pumps, recirculation pumps and nonmetallic magnetic drive centrifugal pumps and systems.


USA • San Diego, CA Tel: (1) 858-866-0788 Web: E-mail: info@ Develops, manufactures, and markets a wide range of one-step diagnostic tests, including cardio markers, infectious diseases, drug abuse, STD, pregnancy, and fertility.

JAJ International

Japan • Tokyo Tel: (81) 42 5422303 Web: Focuses on the production of scientific and metrology instruments such as electron microscopes, ion beam instruments, mass spectrometers and NMR spectrometers. Committed to the development and research, manufacturing, maintenance and service of medical equipment, industrial equipment and other scientific instruments.


USA • Marlborough, MA Tel: (1) 508-263-2900 Web: E-mail: salessupport@ Specializes in products for molecular diagnostics including Aptima assays and advanced automation platforms that allow labs to quickly and accurately detect or monitor infectious diseases. The company’s proven solutions are designed to help promote early detection, appropriate treatment, and better outcomes.


Korea • Anyang Tel: (82) 31-478-8591 Web: E-mail: Develops and manufactures products for IVD and pointof-care testing.


says, ELISA assays, and a protein colorimetric microarray containing 10 DNA/ENA antigens.

Japan • Tokyo Tel: (81) 422-45-6049 Web: Involved in the development of nuclear diagnostic, osteoporosis diagnostic, sample testing, and therapeutic/surgical systems.

E-mail: Develops and manufactures diagnostic products for clinical laboratories including in vitro, clinical chemistry, POC testing, immunology, microbiology, hematology, and coagulation.

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Spain • Barcelona Tel: (34) 937 700 877 Web: E-mail: Produces products that include autoclaves, blood bank cabinets, baths, centrifuges, incubators, blood collection tubes, pipettes, and ESR systems, among others.

JP Selecta

Germany • Numbrecht-Elsenroth Tel: (49) 22-93-9132-0 Web: E-mail: Develops, manufactures and markets treated and untreated test tubes for different blood, urine and feces examinations, blood collection systems for venous and capillary blood, mixers for blood samples, devices for the blood sugar determination and for the determination of the blood sedimentation rate as well as accessories for the handling and disposal of the products.

Kabe Labortechnik

Finland • Turku Tel: (358) 44-584-5062 Web: E-mail: Produces laboratory reagents for clinical chemistry, genetic testing, immunology, hematology, blood bank, and coagulation applications. Additional products offered include chelates, custom reagents and kit components.


USA • Seattle, WA Tel: (1) 206-575-8068 Web: E-mail: Manufactures over 38 immunoassay reagents for chemistry analyzers including the new H. pylori reagent and remnant lipoprotein cholesterol reagent for chemistry

Kamiya Biomedical

analyzers. The reagents offer the best performance / lowest price of any comparable reagents, and are available for lipid, diabetes/stroke, anemia, allergy, inflammation, nutrition, kidney and cardiac testing. The company also offers preclinical human and animal biomarker assay reagents and kits.

Italy • Milan Tel: (39) 2-900-121 Web: E-mail: Supplies a wide range of lightweight, ergonomic products for the laboratory market including plasticware, disposables, and a range of liquid handling options.

Kartell Labware

Kehua Bioengineering

China • Shanghai Tel: (86) 21-6485-0088 Web: E-mail: Develops, manufactures, and markets reagents, automatic clinical chemistry analyzers, microplate readers and washers, electrolyte analyzers, decapping centrifuges, and vacuum blood collection tubes.

Kem-En-Tec Diagnostics

Denmark • Taastrup Tel: (45) 3927-1771 Web: E-mail: Develops and produces superior, technology-enhanced components for colorimetricand chemiluminescent-based immunoassays. The company also provides environmentally friendly, ECO-TEC components for immunoassays, along with substrates, buffers and stabilizers for life science customers in 30+ countries.

UK • Heywood Tel: (44) 161-820-3833 Web: E-mail: Specializes in the development and production of microbiological diagnostic products, including dehydrated culture media and chromogenic media.

Lab M

UK • Cambridge Tel: (44) 1223-395-450 Web: E-mail: Provides molecular diagnostic products and services, along with a range of infectious disease assays, to healthcare organizations, clinical laboratories, and pharmaceutical companies.

Lab21 Healthcare

Sweden • Helsingborg Tel: (46) 42-32-40-00 Web: E-mail: Specializes in reagents and controls for hematology instruments.

LABEX Reagens

Labline Equipments

India • Vadodara Tel: (91) 265-263-2148 Web:

labMedica International December/2019-January/2020


LabMedica 300 E-mail: Manufactures brushless centrifuges, needle destroyers, blood mixers, centrifuges, differential blood cell counters, vortex mixers, dry bath incubators, hematocrit digital centrifuges and roller mixers.

China • Shenzhen Tel: (86) 755-8636-8328 Web: E-mail: Specializes in reagent manufacturing, and focuses on developing reagents for hematology analyzers, clinical chemistry, and urine cell analyzers.

Labnovation Technologies

Brazil • Lagoa Santa Tel: (55) 31-3689-6900 Web: E-mail: Develops, manufactures, and commercializes IVD reagents and diagnostic equipment for the clinical chemistry industry.


USA • Pipersville, PA Tel: (1) 215-795-2838 Web: E-mail: Specializes in polyclonal and monoclonal antibody development, cell culture devices and services, and a wide variety of blood-derived products.

Lampire Biological Laboratories

China • Shenzhen Tel: (86) 755-8652-2242 Web: E-mail: Distributes medical diagnostic imaging equipment, as well as products for medical IT, IVD, hemodialysis, and anesthesia.

Landwind Medical

Taiwan • Taichung City Tel: (886) 42-355-3201 Web: E-mail: Manufactures a range of instruments for clinical chemistry, hematology, coagulation, and blood bank, including the T900 automatic chemistry analyzer.

Lanner Biotechnology

Germany • Nordhorn Tel: (49) 5921-8197-0 Web: E-mail: Develops and produces in vitro diagnostic test systems for the clinical and research laboratory markets.

LDN Labor Diagnostika Nord

USA • Westbrook, CT Tel: (1) 860-399-6281 Web: E-mail: Manufactures miniature fluid control components for automated liquid handling in medical and scientific instrumentation, analytical/clinical chemistry, and medical disposable applications.

Lee Company, The

Germany • Wetzlar Tel: (49) 64-41-29-4099 Web: Manufactures and supplies optical solutions based on microscopes and related instruments

Leica Microsystems

USA • Skillman, NJ Tel: (1) 732-246-3366 Web: E-mail: Provides point-of-care testing solutions for the detection of medical conditions and illnesses that include cardiac markers, infectious disease, women’s health, abused drugs, urinary tract infections, and GI disorders.


China • Shenzhen Tel: (86) 755-2906-0026 Web: E-mail:

Lifotronic Technology


labMedica International December/2019-January/2020

Specializes in development, manufacturing and marketing of bedside treatment and diagnostic products. Company products include a fast-growing IVD diagnostic product line with three major technology platforms, as well as items for wound management with lowlower laser therapy (LLLT).

Italy • Roseto degli Abruzzi Tel: (39) 085-893-0745 Web: E-mail: Develops and manufactures a wide range of high-quality and reliable products for microbiology applications.


Linear Chemicals

Spain • Barcelona Tel: (34) 934 694 990 Web: E-mail: Develops, manufactures and markets in vitro diagnostic

(IVD) instruments and reagents, and accessories for clinical laboratory. The company exports all over the world: the brands Cromatest, Clonatest, Plus-Sed and LiNEAR are distributed in 125 countries.

Switzerland • Frick Tel: (41) 62-865-11-50 Web: E-mail: Manufactures products for the diabetic and IVD markets, including point-of-care tests.

Lobeck Medical

Italy • Milan Tel: (39) 02-3933-061 Web: E-mail: Develops, manufactures, and markets disposable products for clinical chemistry, hematology, serology, microbiology and bacteriology.

LP Italiana

USA • Austin, TX


Tel: (1) 512-219-8020 Web: E-mail: Develops, manufactures, and markets biological testing technologies with applications throughout the life sciences and clinical diagnostics industry.

USA • Lawrenceville, GA Tel: (1) 770-270-1394 Web: E-mail: Supplies products to the laboratory market, including microscopes, centrifuges, and general lab equipment, for applications in hematology, pathology, cytology, and infectious diseases.

LW Scientific

Maccura Biotechnology

China • Chengdu Tel: (86) 028-8173-1888 Web: E-mail: Develops, produces, markets and distributes IVD products for applications in clinical biochemistry, chemiluminescent immunoassay, rapid diagnosis, thrombosis, hemostasis, and molecular diagnosis.

Germany • Düren Tel: (49) 2421-9690 Web: E-mail: Develops, manufactures, and markets antibiotic test papers, photometers, and urine analyzers.


Magna BioSciences

USA • San Diego, CA Tel: (1) 858-481-4400 Web: E-mail: info@ Focuses on point-of-care testing and the development of assays for immunology.

LabMedica 300 Magnasense Technologies

France • Paris Tel: (33) 01-4562-8000 Web: E-mail: contact@ Develops and markets magnetic immunoassays intended to improve rapid diagnostic performance for human and animal diagnostics.


India • New Delhi Tel: (91) 12-0464-6916 Web: E-mail: sales@ Manufactures microscopes and microscope optics for the clinical laboratory market.

Magnus Analytics

Master Diagnostica

Spain • Granada Tel: (34) 958-271-449 Web: E-mail: Develops, manufactures, and markets products for in vitro diagnosis of oncological and infectious diseases in the area of cellular and molecular pathology.

UK • Bootle, Merseyside Tel: (44) 151-933-7277 Web: E-mail: Manufactures and supplies IVD kits, reagents, and equipment for the clinical market with an emphasis on microbiology.

Mast Group

Maxcom Electronic

China • Shenzhen Tel: (86) 0755-2650-4439 Web: E-mail: Designs diagnostic equipment such as automated hematology analyzers, as well as biochemistry analyzers.

Mayo Medical Laboratories

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Canada • Ottawa, ON Tel: (1) 613-592-3400 Web: E-mail: Uses radiation technologies to prevent, diagnose, and treat disease. Two primary areas make up the business: nuclear medicine and ion technologies.

MDS Nordion

Medica Corporation

USA • Bedford, MA Tel: (1) 781-275-4892 Web: E-mail: EasyRATech@ Manufactures simple-touse, highly reliable diagnostic blood testing analyzers, and also designs products to enhance productivity and the quality of care in smallto-medium-size labs. The EasyRA chemistry analyzer is a compact benchtop solution offering a wide range of tests. Blood gas and electrolyte analyzers are routinely used in labs globally where there is the need to lower health care costs.

Medical Biological Union

Russia • Novosibirsk Tel: (7) 383-363-7720 Web: E-mail: Manufactures and markets ELISA products for IVD of infectious diseases, along with performance sera panels for the quality control of kits imported and manufactured in Russia.

Medical Wire & Equipment

UK • Corsham, Wiltshire Tel: (44) 1225-810361 Web: E-mail: Manufactures and distributes gel transport swabs, as well as liquid Amies medium with flock or foam swabs for clinical and industrial microbiology.

Greece • Athens Tel: (30) 210-6606000 Web: E-mail: Specializes in the R&D, production and export of diagnostic reagents, the production of laboratory information software, and the import and distribution of in vitro diagnostics and automated analytical systems.


Finland • Espoo Tel: (358) 9-547-680 Web: E-mail: medix@ Develops, produces and markets monoclonal antibodies, antibody services and recombinant antigens for the IVD industry, as well as diagnostic rapid tests for human healthcare worldwide.

India • Faridabad Tel: (91) 129-4286-600 Web: E-mail: Specializes in products and reagents for in vitro diagnostics, as well as clinical chemistry, POC testing, immicroscopy, munology, hematology, coagulation, blood bank, pipettes, and liquid handling systems.

Melet Schloesing Laboratories

France • Osny Tel: (33) 01-30-75-30-00 Web: E-mail: Produces hematology cell counters and hematology reagents for the clinical lab.

Menarini, A., Diagnostics

Italy • Florence Tel: (39) 55-56801 Web: Focuses on the research and development of diagnostic drugs that target cardiovascular diseases, oncology, and pain/inflammation, asthma.

USA • Lakewood Ranch, FL Tel: (1) 800-331-2716 Web: E-mail: orders@ Specializes in offering histology supplies and equipment, clinical supplies, and lab equipment, along with supplies for toxicology, microbiology, healthcare education, and home health care.

Mercedes Medical

Meridian Bioscience

USA • Cincinnati, OH Tel: (1) 513-271-3700 Web: E-mail: mbi@ Develops, manufactures, and markets immunodiagnostic kits for the diagnosis of infectious diseases.

Meridian Life Science

USA • Memphis, TN Tel: (1) 901-382-8716 Web: E-mail: info@ Provides contract R&D, process development, and manufacturing of critical assay reagents, antigens, antibodies, and contract biological R&D and manufacturing services to the research, diagnostic, and biopharmaceutical markets.

Micro Lab Instruments

India • Ahmedabad Tel: (91) 79-2658-5919 Web: E-mail: Manufactures versatile semi-auto chemistry analyzers; ISE-based electrolyte analyzers for Na/K/ iCa/ Cl;

ELISA plate readers and automated plate washers; coagulation readers (singlechannel and four-channel); hematocrit capillary-based bilirubinometer for neonates; and dry bath incubators.

USA • St. Cloud, MN Phone: (1) 320-253-1640 Web: Email: Produces lyophilized microorganisms for quality control in microbiology laboratories worldwide. The company specializes in clinical, industrial, food quality, environmental and educational markets, and offers over 3,000 items in the product line with more than 500 different lyophilized microorganism strains.


India • Lucknow Tel: (91) 99-1862-5629 Web: E-mail: Manufactures and markets liquid handling products including micropipettes and pipette filling devices for a range of laboratory applications.


USA • Burlington, MA Tel: (1) 800-645-5476 Web: E-mail: emdinfo@ Focuses on bioprocess and bioscience products and is organized into two divisions. The Bioprocess division offers solutions for the development and manufacturing of biologics, while the Bioscience division provides products and applications that improve laboratory productivity.

Millipore Sigma

China • Shenzhen Tel: (86) 755-8188-8998 Web: E-mail: Specializes in the R&D and manufacture of clinical laboratory instruments and reagents that focus on patient monitoring devices, and diagnostic laboratory instruments for disease detection.


Spain • Barcelona Tel: (34) 93-433-58-60 Web: E-mail: Specializes in clinical laboratory services, and manufactures in vitro diagnostic products for clinical biochemistry and serology.


USA • Pasadena, MD Tel: (1) 410-768-3442 Web: E-mail: Produces liquid stable immunoassay reagents, including substrates and conjugates, used in diagnostic testing applications, as well as in research and process testing at pharmaceutical and biotechnology companies.


MP Biomedicals

Japan • Tokyo Tel: (81) 3-5996-8036 Web: Major product line for clinical diagnostics includes both automatic and semiautomatic hematology analyzers. The product range includes economical 2 parameter analyzers to fully automated 22 parameter analyzers with a barcode reader and a 50-sample rack.

MPW Med. Instruments

Nikon Instruments

USA • Solon, OH Tel: (1) 440-337-1200 Web: E-mail: Manufactures and sells a line of life science, fine chemical and diagnostic products. The company’s products range from specialized areas of research to supplying large-scale quantities of fine chemicals. Poland • Warsaw Tel: (48) 22-610-50-14 Web: E-mail: Develops and manufactures a wide range of medical and laboratory centrifuges including universal and special types, low- and highspeed, refrigerated or refrigerated and heated.

MYCO Instrumentation

USA • Bonney Lake, WA Tel: (1) 253-750-0818 Web: E-Mail: info@ Provides clinical laboratory equipment, clinical chemistry analyzers, hematology analyzers, coagulation analyzers, analytical lab equipment, biotechnology equipment, and diagnostic imaging equipment.

Korea • Seoul Tel: (82) 2-6220-7728 Web: E-mail: Specializes in the fields of biomedical engineering, bio-MEMS (Micro-ElectroMechanical Systems), electronics, chemistry, and optics, and have developed innovative products for life science research and pointof-care diagnostics.


National Reference Laboratory

UAE • Abu Dhabi Tel: (971) 2-493-0555 Web: E-mail: In partnership with LabCorp, NRL offers a comprehensive menu of more than 4,700 tests, providing a complete solution for all clinical testing needs.

France • Guipry Tel: (33) 02-23-30-17-83 Web: E-mail: Specializes in research and development, manufacturing and marketing of telediagnostic products including quantitative and multiplex rapid test solutions, as well as laboratory bench readers, and hand-held readers.

NG Biotech

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Nihon Kohden

USA • Melville, NY Tel: (1) 631-547-8500 Web: E-mail: nikoninstruments@ Designs, manufactures, and markets specialized optical lenses. Products include measuring microscopes, as well as biolaboratory, clinical microscopes.

USA • Murrieta, CA Tel: (1) 951-677-5629 Web: E-mail: Comprised of manufacturing facilities for two respected brands of products: International Immunology Corporation and Midland BioProducts Corporation. The company is ISO-certified (9001:2015) for the design, manufacture and supply of bulk polyclonal antisera and complementary products, as well as the manufacturing and supply of products in bulk quantities as raw material to immunodiagnostic assay manufacturers.

Nittobo America

Nordic Biomarker

Sweden • Umea Tel: (46) 90-71-86-01 Web: E-mail: info@ Specializes in the development and manufacturing of specialty coagulation assays.

USA • Waltham, MA Tel: (1) 781-894-0800 Web: E-mail: Develops whole blood analyzers to support the care of critically ill patients. Product applications include usage in the central laboratory, emergency department, surgery, critical care area, or respiratory care area.

Nova Biomedical

Medix Biochemica

Medsource Ozone Biomedicals

USA • Rochester, MN Tel: (1) 507-266-5700 Web: E-mail: Offers 3,000+ tests and provides access to Mayo Clinic physicians and scientists. As part of the Mayo Clinic’s Department of Laboratory Medicine and Pathology, the company performs tests for Mayo Clinic patients and provides reference testing for 4,000+ hospitals, clinics,

Finland • Vantaa Tel: (358) 40-5435-989 Web: E-mail: Manufacturer of a compact POC assay system based on antibodies labeled with paramagnetic particles that is easily integrated into labs and near patient settings.

and labs in more than 70 countries worldwide.

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NovaTec Immundiagnostica

Germany • Dietzenbach Tel: (49) 6074-4876-0 Web: E-mail: Develops and manufactures ELISA diagnostic kits with an emphasis on infectious diseases, allowing for the rapid diagnosis of bacterial, viral, and parasitic diseases.

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LabMedica 300 USA • Plymouth, MN Tel: (1) 763-553-1270 Web: Manufactures biological safety cabinets, CO2 water-jacketed incubators, laminar air flow equipment, ultra-low temperature freezers, and complementary products and systems.


Turkey • Ankara Tel: (90) 312-399-2830 Web: E-mail: Manufactures and distributes a wide range of laboratory equipment including incubators, deep freezers, dry heat sterilizers, ovens, centrifuges, water baths and water distillers, blood bank refrigerators, safety cabinets, and benchtop steam sterilizers.


USA • Vancouver, WA Tel: (1) 360-546-1563 Web: E-mail: Manufactures saliva collection devices and test kits, as well as ELISA products for HIV, drugs of abuse, and steroid hormones.

Oasis Diagnostics

UK • Alva, Scotland Tel: (44) 1259-763-030 Web: E-mail: Develops and manufactures IVD products, specializing in the areas of allergy, food intolerance, autoimmune disease, and infectious disease.

Omega Diagnostics

Spain • Zaragoza Tel: (34) 976-50-3597 Web: E-mail: Manufactures and markets immuno and molecular in vitro diagnostic products including lateral flow tests, and molecular tests for clinical diagnostics.


USA • Bethlehem, PA Tel: (1) 610-882-1820 Web: E-mail: Develops, manufactures and markets oral fluid specimen collection devices, as well as diagnostic products including immunoassays and in vitro diagnostic tests.

OraSure Technologies

Germany • Mainz Tel: (49) 6131-9258-0 Web: E-mail: Focuses on the development and production of autoimmune ELISA test systems.

Orgentec Diagnostika

Switzerland • Geneva Tel: (41) 22-884-90-90 Web: E-mail: contact@ Develops and markets instrumentation for the hematology diagnostic market, addressing the needs of small and mid-sized laboratories, as well as physician offices.

Orphee Medical

USA • Raritan, NJ Tel: (1) 800-828-6316 Web: Focuses on diagnostic products for donor screening, immunohematology, clinical chemistry, and immunodiagnostics.

Ortho-Clinical Diagnostics

USA • Hicksville, NY Tel: (1) 516-933-4500 Web: E-mail: Develops and manufactures equipment ranging from small precision tabletop liquid dispensers to fully integrated, multifunction systems on a variety of conveyor and robotic platforms. Applications include liquid handling, automation and systems integration.

Oyster Bay Pump Works


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Germany • LaudaKönigshofen Tel: (49) 0-9343-6270-0 Web: E-mail: info@ Offers a comprehensive range of laboratory glassware including microscope slides, cover glass, counting chambers, capillary tubes, lab containers, and volumetric glassware.

Paul Marienfeld

Switzerland • Aesch BL Tel: (41) 61 7064848 Web: E-mail: Specializes in research, development, and production of active ingredients for the pharmaceutical industry, as well as diagnostic products relating to hemostasis.


USA • Black Diamond, WA

Peripheral Visions

Tel: (1) 253-735-3910 Web: E-mail: Provider and exporter of replacement parts and supplies for use on most major brands of clinical chemistry analyzers. For over 32 years, the company has been serving hospitals, labs, service groups, MOH’s, the analyzer and reagent manufacturing community, as well as others worldwide.

USA • Waltham, MA Tel: (1) 203-925-4602 Web: Provides scientific instruments, consumables and services to the pharmaceutical, biomedical, environmental testing and general industrial markets. Designs and manufactures systems for the life, analytical, and optoelectronics markets.


Perlong Medical Equipment

China • Nanjing Tel: (86) 25-5263-5350 Web: E-mail: Provides products that include clinical laboratory equipment and reagents, surgical equipment and blood analytic equipment, and X-ray video devices.

Netherlands • Etten Leur Tel: (31) 765-433-833 Web: E-mail: Specializes in products for lab conservation, incubation, and sterilization, along with offering a range of Biocision CoolProducts.

PHC Europe

Pointe Scientific / MedTest USA • Canton, MI Tel: (1) 734-487-8300

Web: E-mail: Offers Pointe Scientific, MedTest DX, and Clinitox Diagnostix brand products to the clinical diagnostics industry. Products include analyzers, reagents, calibrators and standards, controls, and solutions for diabetes, cardiovascular disease, lipid, renal, hepatic and more.

USA • Cortlandt Manor, NY Tel: (1) 914-739-5400 Web: E-mail: Provides instruments and reagents for clinical chemistry and hematology, as well as POC tests for FOBT, cholesterol, diabetes, and bladder cancer detection.


USA • Fairburn, GA Tel: (1) 770-964-1421 Web:


LabMedica 300

Puritan Medical Products

USA • Guilford, ME Tel: (1) 207-876-3311 Web: E-mail: sales@ Manufactures specialty and single-use products for medical and diagnostic applications, including swabs and tipped applicators.

Germany • Hilden Tel: (49) 2-103-29-12000 Web: Specializes in sample and assay technologies used to isolate and process DNA, RNA, and proteins from biological samples such as blood or tissue.


Radiometer Medical

Denmark • Copenhagen Tel: (45) 38-27-38-27 Web: E-mail: Products include blood gas analyzers; combined blood gas electrolyte, metabolite and oximetry analyzers; transcutaneous blood gas monitors.

RAL Técnica para el Laboratorio

Spain • Barcelona Tel: (34) 93 480 80 47 Web: E-mail: Offers service to the clinical chemistry diagnostic field, focusing on the in vitro diagnostic field.

Finland • Toivala Tel: (358) 10-5045-200 Web: E-mail: Focuses on areas of pointof-care diagnostics of infectious disease and immunity. Products include the development of ready-to-use test kits for POC and lab medicine.


USA • Devens, MA Tel: (1) 978-772-9070 Web: E-mail: Supplies quality control materials and related products for blood gas, critical blood analyte, and diabetes care applications. The product line includes daily QC materials, calibration verification and linearity products, and glass capillary blood collection tubes.

RNA Medical

India • Mumbai Tel: (91) 251-268-9000 Web: E-mail: export@ Designs and manufactures diagnostic instruments intended to meet a wide spectrum of user requirements including a variety of analyzers and ELISA plate readers and washers, as well as urine analyzers and reagents.

Robonik India

Switzerland • Basel Tel: (41) 61-688-1111 Web: Develops, manufactures, and markets a wide range of in vitro diagnostic systems, instruments, reagents, and tests.

Roche Diagnostics

Randox Laboratories

UK • Crumlin, County Antrim Tel: (44) 0-28-9442-2413 Web: E-mail: Specializes in diagnostic reagents and equipment for laboratory medicine. Products include Biochip Array Technology, clinical chemistry automation systems, quality control materials, external quality assurance schemes, clinical reagents, and environmental diagnostics.

USA • Redondo Beach, CA Tel: (1) 310-536-0006 Web: E-mail: Designs, develops and manufactures a specialized portfolio of quality control products and OEM services that improve the efficiency and reliability of laboratory testing and patient care.


Germany • Darmstadt Tel: (49) 6151-8102-0 Web: E-mail: Develops, produces and markets enzyme immunoassays for the detection of human infectious diseases. The product line contains test systems in the field of stool diagnostics, infectious disease, serology, and allergy testing.


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Germany • Dreieich Tel: (49) 0-6103-30025-0 Web: E-mail: Produces easy-to-operate, reliable devices for medical and biochemical laboratories.


USA • San Antonio, TX Tel: (1) 210-699-8800 Web: E-mail: Focuses on rapid diagnostic tests for infectious and bacterial diseases, as well as food microbiology, veterinary testing, and environmental testing.

SA Scientific

Sakura Finetek Europe

Netherlands • Alphen aan den Rijn Tel: (31) 88-592-00-00 Web: E-mail: Manufactures products with

USA • State College, PA Tel: (1) 814-234-2617 Web: E-mail: Provide researchers, analytical and functional testing laboratories, and the immunodiagnostic industry with innovative salivary immunoassay products and services.


Korea • Seongnam Tel: (82) 2-2194-1000 Web: Develops, manufactures, and markets diagnostic products and solutions for IVD and point-of-care applications.


Netherlands • Amsterdam Tel: (31) 20-512-30-00 Web: E-mail: Provides blood supplies and promotes transfusion medicine. The company has also developed a range of reagents, including several products for diagnostic use and for fundamental and clinical research.

Sanquin Reagents

Germany • Nümbrecht Tel: (49) 2293-3050 Web: E-mail: Develops, manufactures, and sells consumables and analytical equipment for medical diagnostics, as well as consumables, laboratory aids, and laboratory equipment for industrial and research laboratories.


Savyon Diagnostics

Israel • Ashdod Tel: (972) 8-8562920 Web: E-mail: info@ Develops, manufactures, and markets diagnostic kits for the detection of infectious diseases and genetic screening. USA • Framingham, MA Tel: (1) 877-740-2129 Web: E-mail: Develops scientific instrumentation, software, and services used to advance science in the fields of basic research, drug discovery & development, food & environmental testing, forensics and clinical research.


USA • Dover, NJ Tel: (1) 973-625-8822 Web: E-mail: Specializes in immunofluorescence, rapid, and ELISA


technologies for a wide variety of unique and routine autoimmune, parasitic and infectious diseases, as well as particle agglutination, column chromatography and fractionation and conjugation of sera.

hematology, biochemistry, and immunology sectors.

SD Biosensor

Shenzhen New Industries Biomedical Engineering (SNIBE)

Korea • Suwon Tel: (82) 31-300-0400 Web: E-mail: Manufactures in vitro diagnostic systems used in POC, hospitals, and central labs. Products include HbA1c analyzers, cholesterol analyzers, and blood glucose monitoring systems, as well as rapid tests for infectious diseases.

France • Evry Tel: (33) 1-6989-8080 Web: Specializes in the design and development of instruments and assays for electrophoresis. Products include automated capillary electrophoresis instruments, carbohydrate-deficient transferrin, high-resolution capillary electrophoresis and hemoglobin assays.


USA • Burlington, MA Tel: (1) 781-652-7800 Web: E-mail: Develops, manufactures, and supplies clinical chemistry and coagulation systems, as well as reagents, infectious disease rapid tests, LINE immunoassays, ELISA kits, enzymes, and specialty biochemicals.

Sekisui Diagnostics

Korea • Seoul Tel: (82) 2-6968-5278 Web: E-mail: Conducts research on protein translation and modification in the proteome level so that proteins that are directly related to diseases can be found to protect and detect diseases beforehand.


Spain • Amposta Tel: (34) 977-706-230 Web: E-mail: Manufactures IVD reagents for use in biochemistry, immunology, hemostasis, microbiology, histopathology, and hematology applications.

China • Shenzhen Tel: (86) 755-8883-2350 Web: E-mail: Develops, manufactures, markets and services clinical laboratory instruments and reagents. The company’s product range comprises chemistry analyzers, microplate readers, microplate washers, and coagulation analyzers.

a focus on tissue samplers and processors, as well as automated slide stainers and coverslippers. Brands offered include Tissue-Tek, Cyto-Tek and Accu-Edge.

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Sentinel Diagnostics

Italy • Milan Tel: (39) 0-2-3455-141 Web: E-mail: Develops and supplies in vitro diagnostic reagents for clinical laboratories.

Ireland • Limerick Tel: (353) 61-358-190 Web: E-mail: Distributes a range of laboratory diagnostic products for clinical and environmental labs.


France • Saint Jean d’Illac Tel: (33) 0-5-56-68-80-50 Web: E-mail: Manufactures and exports in vitro diagnostic instruments and reagents, specializing in human biological analysis and concentrating on routine clinical testing in the


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China • Shenzhen Tel: (86) 755-8654-0750 Web: E-mail: Specializes in clinical laboratory instruments and IVD reagents including the production of nano magnetic microbead products, automated CLIA systems, analyzers and matched reagent kits, and magnetic enzyme immunoassay analyzers and matched reagent kits.

China • Shenzhen Tel: (86) 755-2674-7910-807 Web: E-mail: Develops, manufactures, and services medical testing instruments, as well as offers a series of hematology analyzers.

Prokan Electronics

Quimica Clinica Aplicada

Rayto Life and Analytical Sciences

Germany • Bensheim Tel: (49) 6251-707-110 Web: E-mail: The company focuses on point-of-care diagnostics, preventive medicine and therapy monitoring. Tests can be evaluated quickly and quantitatively with a smartphone app, enabling effective practice management and possibilities for telemedicine solutions.


USA • San Diego, CA Tel: (1) 858-552-1100 Web: E-mail: customerservice@ Develops, manufactures and markets rapid diagnostic tests at the point-of-care (POC) that focus on infectious diseases and reproductive health.


E-mail: info.porex.emea@ Develops and manufactures advanced porous plastic materials, porous PTFE, glass fiber, porous polymer fiber, certified Pure Porex media and functionalized and bio-activated porous materials. The products serve the healthcare and bioscience end markets for use in clinical science, liquid handling, molecular and microfluidic diagnostic applications.

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Siemens Healthineers

Germany • Erlangen Tel: (49) 69-6682-6602 Web: Offers a broad spectrum of immunoassay, chemistry, hematology, molecular, urinalysis, and blood gas testing systems, along with automation, informatics, and services that can serve the needs of labs of any size today and tomorrow.

China • Shenzhen Tel: (86) 0755-23704711 Web: E-mail: Develops molecular diagnostic systems, focusing on isothermal amplification and PCR. Products are applicable to biomedical, food sanitation, environment monitoring and other fields. Produces a new nucleotide isothermal amplification analyzer capable for testing for virus, infectious disease, microorganism, tumor DNA, antibiotic-resistance DNA, and food safety.

Singuway Biotech

China • Nanjing Tel: (86) 025-8412-7188 Web: E-mail: Specializes in researching, developing and manufacturing clinical laboratory equipment and reagents. The company has developed fully automatic clinical chemistry analyzers, coagulometers, microplate readers, and diagnostic reagents.


Norway • Oslo Tel: (47) 90-68-46-96 Web: E-mail: Develops, manufactures, and markets software for image recognition, capturing, and analysis of bioassays, within the field of clinical diagnostics.


USA • Carlsbad, CA Tel: (1) 760-930-9496 Web:

SLR Research

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LabMedica 300 E-mail: Supplies a broad range of essential biologicalbased, bulk human disease-state and normal sera, specialty/esoteric antibodies, controls/calibrators and the IRB Clinical Specimen Repository.

India • Chennai Tel: (91) 44-2374-5508 Web: E-mail: expcustomersupport@ Designs and markets diagnostic instruments and reagents, including products for semiautomatic coagulation analysis, and sodium potassium analysis.

SM Diagnostics

Switzerland • Ecublens Tel: (41) 21-651-6000 Web: E-mail: Designs and manufactures liquid handling instruments including manual and electronic micropipettes, multichannel pipettes, repeater pipettes, dispensers, pipette controllers, automatic and reusable syringes, pipette tips, and accessories.


Spain • St. Esteve d'en Bas (Girona) Tel: (34) 972-690-800 Web: E-mail: Develops and manufactures in vitro diagnostic reagents. Product applications include serology, clinical biochemistry, immunochemistry, rapid tests, blood grouping, coagulation, electrophoresis, and diagnostic instruments.


USA • Sterling Heights, MI Tel: (1) 586-731-6000 Web: E-mail: Designs and manufactures imaging systems for pathology applications, including scientificgrade digital cameras for microscopes.

SPOT Imaging Solutions

Denmark • Copenhagen Tel: (45) 3268-3268 Web: E-mail: Specializes in the research and production of products that address infectious diseases and congenital disorders.

SSI Diagnostica

USA • McKinney, TX Tel: (1) 972-436-1010 Web: E-mail: Specializes in providing histology, cytology and other consumable supplies to more than 3,000 anatomic pathology laboratories throughout the United States.


Germany • Birkenfeld Tel: (49) 7082-7916-0 Web: E-mail: Develops and manufactures reagents and kits for DNA/RNA stabilization, extraction, and purification using manual and automated systems.

STRATEC Biomedical

USA • Omaha, NE Tel: (1) 402-333-1982 Web: E-mail: Manufactures hematology, chemistry, and immunology products. The company is considered an innovator of hematology control products, having developed some of the first hematology reference controls and has since developed additional control products for automated instruments.


Korea • Deajeon Tel: (82) 42-364-5000 Web: E-mail: Manufactures next-generation products for IVD applications including personal POCT products, mobile healthcare products, and per-



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sonalized diagnosis/treatment solutions based on biotechnology, information technology, and nanotechnology.

Sunostik Medical Technology

China • Changchun Tel: (86) 431-8465-0222 Web: E-mail: Specializes in researching, manufacturing, and marketing biochemical analyzers, coagulators, diagnostic reagents, and microwave therapeutic machines.

Sunquest Information Systems

USA • Tucson, AZ Tel: (1) 520-570-2000 Web: E-mail: Focuses on laboratory information and solutions specifically designed for general laboratory, pathology, blood bank, microbiology, molecular, and

other specialty areas in the clinical diagnostic field.

USA • Springfield, MA Tel: (1) 413-543-1442 Web: E-mail: Specializes in the design, development and manufacturing of foam swabs and applicators. From medical applicators to cleanroom-compatible swabs, the advanced foam swabs are designed for precision cleaning of lab equipment and delicate surfaces, collecting samples, removing excess materials, applying lubricants, solvents, adhesives, topical antiseptics and a range of other solutions.

Super Brush

USA • Eden Prairie, MN Tel: (1) 952-500-7000 Web: E-mail: IVDtechsupport@ Develops reagents and appli-


cations for the biomedical research and diagnostic markets. The company provides high-sensitivity substrate chemistries and various diagnostic applications involving highsensitivity chromogen substrates (colored chemical markers). Distributes and supports automated in vitro diagnostic hematology, coagulation and urinalysis analyzers, reagents, and information systems for laboratories and healthcare facilities.

Sweden • Malmo Tel: (46) 40-53-76-00 Web: E-mail: Develops, manufactures and markets diagnostic kits and reagents for use in medical assessments. Product applications include clinical autoimmunology, microbiology, histology/cytology, and immunochemistry.

Taiwan • Taipei City Tel: (886) 2-2889-1136 Web: E-mail: Specializes in the development and manufacture of fully automated DNA/RNA extraction and qPCR instruments and reagents. The LabTurbo systems and kits are designed for fast, fully automated and precise molecular diagnostics and applications in various fields with versatile functions.



Svar Life Science

Germany • Norderstedt Tel: (49) 40-527-260 Web: E-mail:

Taigen Bioscience

Switzerland • Männedorf Tel: (41) 44-922-81-11 Web: E-mail:

LabMedica 300

USA • Anaheim, CA Tel: (1) 714-463-1111 Web: E-mail: Teco Diagnostics manufactures a range of products including urine reagent strips, clinical chemistry reagents, rapid tests, serology latex kits, ELISA, instruments, and blood glucose devices.

Teco Diagnostics

China • Nanchang Tel: (86) 791-8811-0293 Web: E-mail: Develops and manufactures in vitro diagnostic reagents, as well as high tech medical equipment, including biochemistry analyzers.

Tecom Science

Telstar Technologies

Spain • Terrassa Tel: (34) 937-361-600 Web: Designs and manufactures laboratory equipment for R&D, quality control, and analysis in sectors related to life and health sciences. Products available include vertical and horizontal laminar flow benches, biosafety cabinets, lyophilizers, containment and sterile isolators, and ultrafreezers.

USA • Waltham, MA Tel: (1) 781-622-1000 Web: Provides analytical instrumentation, lab equipment, automation technologies, reagents and consumables, and LIMS solutions to determine disease markers or analytes of diagnostics interest.

Japan • Tokyo Tel: (81) 3-5427-5118 Web: Provides in vitro diagnostic analyzers, products and services for Immunoassay and HPLC applications.

Tosoh Bioscience

Japan • Osaka Tel: (81) 6-6348-3888 Web: Manufactures biopharmaceuticals using genetically engineered animal cells, specializing in cell culture technology, usable protein refinement and genetic and cell engineering. Currently, the company is focusing on genome drug discovery support and contract manufacturing of therapeutic antibodies.


TriLink BioTechnologies

USA • San Diego, CA Tel: (1) 858-546-0004 Web: E-mail: Manufactures custom oligonucleotides, modified nucleoside triphosphates and CleanAmp PCR products for the diagnostic market.

Ireland • Bray Tel: (353) 1-276-9800 Web: E-mail: Specializes in the development, manufacture, and marketing of products for point-of-care (POC) and the clinical laboratory. The test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases.

Trinity Biotech

Taiwan • Zhunan Tel: (886) 37-585988 Web: E-mail: Specializes in advanced rapid in vitro immunodiagnostic test systems, including blood glucose monitoring systems for everyday use, and electrical biosensing systems.

Tyson Bioresearch

Russia • Novosibirsk Tel: (7) 383-3326-749 Web: E-mail: Focuses on the research, development, and manufacture of ELISA kits and clinical chemistry reagents for public health.


France • Alençon Tel: (33) 2-33-27-56-25 Web: Offers a range of rapid immunodiagnostic products for professional, home use and point-of-care (POC) testing. The company supplies fertility, infectious disease, drugs of abuse, tumor marker, cardiac marker and specializes in syphilis, tuberculosis, malaria and hepatitis tests.


See ad oN paGe 8

India • Surat Tel: (91) 261-246-3777 Web: E-mail: Manufactures rapid test kits, blood grouping sera, latex test kits, febrile antigen reagents, ELISA test kits, blood collection tubes and lab plastic consumables.

Voxtur Bio

USA • Irwindale, CA Tel: (1) 626-443-8480 Web: E-mail: Focuses on the research and development of onestep rapid membrane tests. Also, with sister company W.H.P.M. Bioresearch Technology Co., Ltd., W.H.P.M. has researched, developed, and produced rapid test systems that include current product Hemosure.


Brazil • São Carlos Tel: (55) 16-3377-9977 Web: E-mail: info@ Focuses on providing the clinical chemistry industry with products for extensive laboratory test procedures with products for rapid tests, pharmaceutical, latex, hemagglutination, immunofluorescence, and ELISA testing.

Wama Diagnostica

USA • Milford, MA Tel: (1) 508-478-2000 Web: E-mail: customerservice@ Designs, manufactures, sells and services ultra performance liquid chromatography (UPLC), high performance liquid chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry (MS) systems, thermal analysis and rheometry instruments.


Switzerland • Pully Tel: (41) 21-728-4286 Web: E-mail: Specializes in the production of hospital and laboratory equipment, including products for central sterilization.


Germany • Oberhausen Tel: (49) 208-305-505-0 Web: E-mail: Specializes in the field of blood gas and offers plastic end-to-end capillaries, plastic heparinized blood gas capillaries and syringes, and capillary blood collection systems.


Spain • Granada Tel: (34) 958-44-12-64 Web: E-mail: Develops, manufactures and markets ready-to-use kits for the diagnosis of human infectious diseases. The company specializes in R&D and offers complete diagnostic solutions for techniques including CLIA Monotest, ELISA, IFA, DFA, rapid tests, PCR controls and other unique in-house developments.


Germany • Pforzheim Tel: (49) 7081-177-0 Web: E-mail: Develops, manufactures, and distributes high-performance instruments for life science


Japan • Tokyo Tel: (81) 3-6841-8300 Web: Develops and markets a multifunction, small-sized automatic biochemical analyzer that is capable of processing 240 tests an hour.

Tokyo Boeki

China • Guilin Tel: (86) 773 2288586 Web: E-mail: Manufactures urine analyzers and reagent strips. The product range has expanded from single urine analyzers to multistructure urine analyzers, hematology analyzers, as well as biochemistry analyzers.

URIT Medical

Spain • Madrid Tel: (34) 91-382-16-20 Web: E-mail: Specializes in products including reagents and intelligent analysis software for application in flow cytometry, FISH probes for detecting nonrandom chromosomal abnormalities, software applications for pathology and PCR kits for HPV and lymphomas.


See ad oN paGe 30

Austria • Wiener Neudorf Tel: 43 (0) 2236 892465 Web: E-mail:

West Medica

Designs equipment for laboratory research and microscopy.

Wiener Laboratorios

Argentina • Rosario Tel: (54) 341-432-9191 Web: E-mail: marketing@ Develops, manufactures and markets diagnostic reagents. Products are intended for clinical chemistry, specialized hospital laboratories, as well as for blood banks. Applications include in vitro diagnostic reagent kits for use in clinical chemistry and coagulation.

USA • Vineland, NJ Tel: (1) 856-691-3200 Web: E-mail: Manufactures NMR and EPR sample tubes and accessories, as well as precision-engineered glass, OEM quartz components and assemblies.


Germany • Gottingen Tel: (49) 0-36081-68940 Web: E-mail: Specializes in stationary and mobile safety laboratory gas burners, as well as electrical sterilization systems, and a wide range of available accessories.


China • Guangzhou Tel: (86) 20-3229-6083 Web: E-mail: sales@ Manufactures medical diagnostic testing kits, as well as biochemical reagents. The company focuses on labeling techniques with automated procedures for water purgation, cell cultivation, purity analysis, packaging, and sorting and testing.

Wondfo Biotech

Worthington Biochemical

USA • Lakewood, NJ Tel: (1) 732-942-1660 Web: E-mail: international@ Produces purified enzymes, proteins, nucleic acids and related biochemicals for cell biology, biochemistry, protein and DNA/RNA applications. The company also produces collagenases, nucleases and other proteases and usetested kits for the isolation of primary cardiomyocytes, neurons and hepatocytes. Animal-origin FREE collagenases, RNases, DNases and proteases are available for stem cell and biopharmaceutical applications.

China • Shanghai Tel: (86) 21-57687666 Web: E-mail:


Specializes in development, production and sales of clinical testing equipment. Products include a range of electrolyte analyzer series, western blot system series and erythrocyte sedimentation rate analyzer series. See ad oN paGe 12

Yashraj Biotechnology

India • Navi Mumbai Tel: (91) 22-6216-6800 Web: E-mail: marketing@ Focuses on R&D and processing of native and recombinant antigens and antibodies having diagnostic applications. The company supplies high-quality antigens and antibodies to the diagnostics industry, manufactures assays and controls and offers OEM services.

Korea • Yongin Tel: (82) 31-329-2000 Web: E-mail: admin@ Develops, manufactures, and distributes diagnostic products for liquid-based cytology, MDx, and urinalysis. Products available include processors, fully automated systems, rapid tests, strips, and chemistry reagents.

YD Diagnostics

China • Shenzhen Tel: (86) 755 26601910 Web: E-mail: Specializes in developing, manufacturing, and distributing in vitro diagnostic instruments and reagents.

YHLO Biotech

Thermo Fisher Scientific

Turkey • Ankara Tel: (90) 312 397 0173 Web: E-mail: Manufactures semiautomatic coagulation analyzers, as well as diagnostic instruments for hemostasis, clinical chemistry, cytogenetics, genetics, research and molecular biology.

Tokra Medikal

Korea • Seongnam Tel: (82) 31-721-8003 Web: E-mail: Develops manual and fully automated tissue microarrayers, as well as paraffin block trimmers, for various lab applications.


France • CroissyBeaubourg Tel: (33) 1-64-62-10-12 Web: E-mail: Develops, manufactures and distributes in vitro diagnostic tests, as well as theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. The company markets the Lisa Tracker range (CE marked), which is a comprehensive multiparameter theranostic solution for patients with autoimmune diseases treated with biotherapies.


labs, including easy-to-use instruments for biomedical, pharmaceutical, biotechnological, and fundamental research communities.

Specializes in the development, production, distribution and servicing of solutions for the discovery of pharmaceutical substances, as well as genomics, proteomics and diagnostics. The company develops measurement, analysis, and laboratory automation instruments.

See ad oN paGe 33

Israel • Beit Shemesh Tel: (972) 2-995-5550 Web: E-mail: Develops, manufactures, and markets a wide range of one step, rapid, and Elisa diagnostic tests.

Zer Hitech

Turkey • Istanbul Tel: (90) 212-210-6215 Web: E-mail: Provides ready-to-use LCMS/MS and HPLC analysis kits to the clinical diagnostic field. The company also supplies its own fully automated sample preparation and injection system, which allows labs to make efficient use of their LC-MS/MS and HPLC instruments in a fast, accurate, and cost-effective way.

Zivak Technologies

Germany • Berlin Tel: (49) 30-804-984-990 Web: E-mail: international@ Develops, produces, and distributes antibodies and detection systems for diagnostics and research applications.

Zytomed Systems

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Eurotrol IQ Products PHC Europe Sakura Finetek Europe Sanquin Reagents

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