LabMedica International November 2023 by Globetech

SEE US AT

V I S I T

WORLD’S CLINICAL LABORATORY NEWS LEADER

MEDICA®

2023 Hall 1• H61

ISSN 1068-1760

Vol.40 No.7 • 11/2023

DAILY CLINICAL LAB NEWS

Predicting Diabetic Kidney Failure

Blood Test Detects Chronic Fatigue Syndrome at Over 90% Accuracy

ntil now, the presence of protein (albumin) in the urine has been the key indicator for kidney disease. However, nearly half of diabetes patients who experience kidney failure do not exhibit substantial protein levels in their urine. Now, in the first-

yalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) is marked by extreme tiredness that deeply affects the quality of life for those who suffer from it. The issue with diagnosing ME/CFS is the lack of a straightforward, reliable test, causing

many to rely on self-assessment and questionnaires for a diagnosis. There’s a significant need for a simple diagnostic method that could lead to earlier identification of the condition, thereby helping patients better manage their symptoms and paving the way

Cont’d on page 6

Cont’d on page 13

Breakthrough Diagnostic Technique Could Transform Cancer Treatment D

POC Technique Rapidly Detects Pathogens eceiving results from a blood test or other diagnostic assessments often involves a waiting period of up to several days, depending on the specific test’s target. This time lag can be primarily attributed to the laborious steps in sample processing and analysis. The quantities of pathogens in fluid samples are so minute that they require cultivation in controlled settings to increase

Cont’d on page 4

Blood Test Predicts Osteoporosis he worldwide rates of osteoporosis are soaring, yet public understanding of the disease and its risk factors is alarmingly inadequate. Following their first fracture, the quality of life for osteoporosis patients usually takes a steep decline, and a quarter of these individuals pass away within a year. Detecting the condition early is critical to lowering the risks of severe health con-

uring chemotherapy, some cells can become not only treatment resistant but also potentially more harmful and even metastasize. Now, a combination of three advanced rapid-live screening microscopy methods can detect such cells much earlier, thereby significantly improving cancer treatment. See article on page 5

Cont’d on page 10 V

LINKXPRESS COM R E A D E R

POC Test Diagnoses Parkinson’s in 8 Minutes

INSIDE

LabMedica EXPO . 6-28

S E R V I C E

P O R T A L

Renew/Start your Free Subscription

arkinson’s Disease (PD) is the second most prevalent neurodegenerative disorder, following Alzheimer’s, affecting over 10 million people globally. One key biomarker for PD is abnormal alpha-synuclein. A recent study found a surprising 93% of Parkinson’s patients who took part in the research had this abnormal

Access Interactive Digital Magazine Instant Online Product Information:

Mark code(s) of interest on 3 LinkXpress ® inquiry matrix If your subscription is not renewed every 12 months your Free Subscription may be automatically discontinued

IFCC News . . . . 29-32 Industry News .. . . . 33

Cont’d on page 7

Microbiology Reporting System Advances Infectious Disease Management

Identify LinkXpress ® codes of 1 interest as you read magazine on LinkXpress.com 2 toClick reach reader service portal

Clinical News . . . . 3-28

nfectious pathogens continually evolve, becoming stronger and more strategic as they adapt to new environments and develop resistance to existing treatments. Despite this ongoing evolution, the essential technologies in the fight against antimicrobial resis-

tance (AMR) often lag behind. While pathogens advance, clinical tools can become outdated, failing to provide physicians with accurate and timely information. For example, obsolete lab reporting technologies not only lack efficiency but also hamper the battle Cont’d on page 14

Events Calendar . . 34 PUBLISHED IN COOPERATION WITH

International Federation of Clinical Chemistry and Laboratory Medicine

GLOBETECH >>> MEDIA <<<

Why choose between

Quality & Convenience? Dipper POCT

offers both!

› 3 months of RT stability & up to 3 years at 2°C – 8°C › Ultra-simple and fast › Ideally suited for every testing environment

The ONLY liquid, single-use urinalysis quality control!*

*Dipsticks not included.

LINKXPRESS COM

LMI-11-23 102

see it in action@

LINKXPRESS COM

LMI-11-23 103

LabMedica International

To view this issue in interactive digital magazine format visit www.LabMedica.com

POC Techniques Rapidly Detects Pathogens

Cont’d from cover

their numbers. Subsequently, these cultures are stained and examined under a microscope. This comprehensive procedure extends over several days to yield a conclusive positive or negative outcome. Now, researchers have identified a new optical signature in a commonly used class of magnetic beads, known as Dynabeads. This discovery holds the potential to speed up the detection of contaminants in various diagnostic tests, such as identifying traces of the foodborne pathogen Salmonella. Dynabeads, microscopic magnetic beads, are capable of being coated with antibodies that attach to specific target molecules, like pathogens. Typically, Dynabeads are integrated into solutions to capture desired molecules, but further time-consuming steps are essential to confirm their presence and attachment to the beads. A team of scientists at Massachusetts Institute of Technology (MIT, Cambridge, MA, USA; www.web.mit.edu) have leveraged optics, specifically Raman spectroscopy, to confirm the presence of Dynabead-bound pathogens. Raman spectroscopy is an optical technique for identifying specific molecules through the unique way in which a molecule scatters light, referred to as their “Raman signature.” The researchers discovered that Dynabeads exhibit an unusually strong Raman signature, similar to a fluorescent tag, enabling rapid detection with this distinctive signature functioning as a “reporter.” Detecting this signal quickly can confirm the existence of a target pathogen in a given sample within less than a second. In a practical demonstration, the researchers mixed Dynabeads into vials containing Salmonella-contaminated water. These beads were magnetically isolated onto microscope slides, after which the researchers measured how light scattered through the fluid upon exposure to laser light. Within just half a second, the Dynabeads’ Raman signature was

labmedica.com EDITORIAL BOARD

Image: Dynabeads (grey spheres) interacting with Salmonella bacterium (in green) (Photo courtesy of MIT)

detected, confirming the presence of bound Dynabeads and, consequently, Salmonella in the fluid. This novel technique surpasses conventional methods in speed and incorporates components that could be adapted into more compact, portable formats. The team is actively working on devising a portable device capable of rapidly detecting an array of bacterial pathogens. In particular, the researchers aim to apply this approach to critical conditions such as sepsis, where prompt pathogen detection is vital and existing lab tests may not rapidly fulfill this requirement. “This technique would be useful in a situation where a doctor is trying to narrow down the source of an infection in order to better inform antibiotic prescription, as well as for the detection of known pathogens in food and water,” said study co-author Marissa McDonald, a graduate student in the Harvard-MIT Program in Health Sciences and Technology. “Additionally, we hope this approach will eventually lead to expanded access to advanced diagnostics in resource-limited environments.” “There are a lot of cases, like in sepsis, where pathogenic cells cannot always be grown on a plate,” said Jongwan Lee, MIT Postdoctoral Associate and study co-author. “In that case, our technique could rapidly detect these pathogens.” The study was published on August 2023 in the Journal of Raman Spectroscopy.

Platform to Advance Speed and Accuracy of POC Testing for Infectious Diseases

merging infectious diseases account for over a billion cases of illness each year and are a major cause of death globally. Vector-borne diseases like mosquitoes are especially dangerous, putting over half of the world's population at risk, as per the World Health Organization. Accurate diagnosis is critical for the effective management of infectious diseases, but traditional lab tests often come with drawbacks like high costs, complexity, slow development, and limited global availability. To tackle these issues, a

new open point-of-care (POC) platform aims to provide quick and accurate POC testing for emerging and neglected infectious diseases. Kephera Diagnostics’ (Framingham, MA, USA; www.kephera.com) MiCRIA Open POC platform aims to fulfill the need for rapid POC testing on a global scale. The platform uses easily produced reagents, allowing for universal accessibility of precise, two-minute POC tests, even in areas lacking resources. Unlike other tests that require disease-speCont’d on page 5

Graham Beastall United Kingdom Hernán Fares Taie Argentina Bernard Gouget France Maurizio Ferrari Italy Jocelyn M. Hicks United States Tahir S. Pillay South Africa Andreas Rothstein Colombia Praveen Sharma India Rosa I. Sierra-Amor Mexico Peter Wilding United States Andrew Wootton United Kingdom A GLOBETECH PUBLICATION

Published in cooperation with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). LabMedica International • LabMedica en Español • LabMedica.com HospiMedica International • HospiMedica.com • MedImaging.net HospiMedicaExpo.com • LabMedicaExpo.com • LinkXpress.com

Marc Gueron Founder & Editorial Director Dan Gueron Publisher

David Gueron Managing Editor Sanjit Dutt News Editor

Carolyn Moody, RN Regional Director Simone Ciolek Regional Director Parker Xu Regional Director

Karina Tornatore Reader Service Manager

HOW TO CONTACT US Subscriptions: www.LinkXpress.com Send Press Releases to: LMNews@globetech.net Advertising & Ad Material: ads@globetech.net Other Contacts: info@globetech.net

ADVERTISING SALES OFFICES USA Carolyn.Moody@globetech.net

Miami, FL 33280, USA Tel: (1) 954-686-0838

GERMANY, SWITZ., AUSTRIA Simone.Ciolek@globetech.net

Bad Neustadt, Germany Tel: (49) 9771-1779-007

OTHER EUROPE & UK Carolyn.Moody@globetech.net

Miami, FL 33280, USA Tel: (1) 954-686-0838

JAPAN Katsuhiro.Ishii@globetech.net

Tokyo, Japan Tel: (81) 3-5691-3335

CHINA Parker.Xu@globetech.net OTHER COUNTRIES ads@globetech.net

Shenzen, Guangdong, China Tel: (86) 755-8375-3877 Contact USA Office Tel: (1) 954-686-0838

SUBSCRIPTION INFORMATION LabMedica lnternational is published eight times a year and is circuIated worldwide (outside the USA and Canada) without charge and by written request, to clinical laboratory specialists and administrators, and other qualified professionals allied to the field. To all others: Paid Subscription is available for a two-year subscription charge of US$120. Single copy price is US$20. Mail your paid subscription order accompanied with payment to Globetech Media, P.O.B. 800222, Miami, FL 33280-0222. For change of address or questions on your subscription, write to: LabMedica lnternational, Circulation Services at above address; or visit: www.LinkXpress.com

ISSN 1068-1760 Vol.40 No.7. Published, under license, by Globetech Media LLC; Copyright © 2023. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.

LabMedica International November/2023

To view this issue in interactive digital magazine format visit www.LabMedica.com

LabMedica International

Breakthrough Diagnostic Technique Could Transform Cancer Treatment

hemotherapy serves as an effective tool in the fight against cancer, yet some cancer cells can evade treatment by going into a dormant state known as senescence. These so-called therapy-induced senescent (TIS) cells can become not just resistant to treatment but also potentially more harmful, even metastasizing. Early identification of TIS cells could be crucial in stopping their progression, but current detection techniques aren't quick or accurate enough. Now, new advanced microscopy techniques may offer a solution, allowing healthcare providers to identify these cells early on and adapt treatment plans accordingly. The research team, which included scientists from Johns Hopkins University (Baltimore, MD, USA; www.jhu.edu) and Politecnico di Milano (Milan, Italy; www.polimi.it), utilized a combination of three state-of-the-art, label-free microscopy methods—coherent Raman scattering, multi-photon absorption, and optical diffraction tomography. This approach gave the scientists the ability to look at the cells’ form, internal structure, and both physical and chemical properties during their entire life cycle. The use of these advanced microscopy methods uncovered significant transformations within the TIS cells. For instance, within a day, the cells' mitochondria—the "energy factories" inside them—had repositioned themselves. By the 72-hour mark, the cells

had started to excessively produce fatty molecules known as lipids and had become flatter and larger. This in-depth analysis helped the researchers establish a detailed timeline of these cellular changes. According to the team, their novel rapid-live screening microscopy methods offer great potential for advancing cancer research. "Our work demonstrates the potential to transform anticancer treatment research," said Ishan Barman, an associate professor of mechanical engineering at Johns Hopkins Whiting School of Engineering. "Integrating these microscopy methods could help clinicians make more informed, timely treatment decisions." The team published their results in the journal Science Advances on September 13, 2023.

CLINICAL CHEMISTRY

Platform to Advance Speed and Accuracy of POC Testing for Infectious Diseases

COAGULATION

RAPIDS

CONTROLS & CALIBRATORS

URINALYSIS

IMMUNOCHEMISTRY

HEMATOLOGY

POINT OF CARE TESTING

SEROLOGY

ELECTROLYTE

BLOOD GROUPING

MOLECULAR

REAGENTS YEARS

Automatic Chemiluminescence Analyzer

Automatic Hematology Analyzer

• Acridinium Ester Direct Chemiluminescence Immunoassay • Multiple Magnetic Separation Technology • Throughput of 200 T/H • 20 Reagent & 50 Sample Positions • Wider Test Menu

• Throughput of 80 T/H • Nucleic Acid Fluorescence Staining and Flow Cytometry • Autoloader with 50 Sample Positions • 28 Parameters with 2D & 3D Scattergram and 3 Histogram • Reliable Performance for Aging Blood/Abnormal Sample

Cont’d from page 4

cific strips or cartridges, this patent-pending system employs a generic cassette and assay-specific reagents. Furthermore, the assay is based on microfluidic technology rather than membrane-based methods. The test-specific reagent is derived by an antibody, antigen, or other ligand, and can be quickly mass-produced using standard laboratory equipment. The platform features a compact and economical reader that can be managed through a smartphone or another mobile device to conduct tests as well as interpret and display results. Kephera's MiCRIA Open POC platform has shown to have better sensitivity compared to lateral flow rapid tests and is almost as effective as ELISA tests.

LabMedica International November/2023

AGAPPE DIAGNOSTICS SWITZERLAND GmbH Knonauerstrasse 54 - 6330 Cham, Switzerland. Tel: +41 41 780 60 10 | Fax: +41 41 780 60 11 info@agappeswiss.com / marketing@agappeswiss.com | www.agappe.com LINKXPRESS COM

LMI-11-23 105

VISIT US @ MEDICA 2023

HALL 1 STALL # D04

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

APOE4 BLOOD TEST

HBA1C TURBIDIMETRIC IMMUNOASSAY

CELL CULTURE ANALYZER

The Randox ApoE4 Array is a rapid and highly sensitive blood test for the rapid identification of Alzheimer’s disease risk by facilitating direct ApoE4 genotyping without the need for molecular genotyping.

The HbA1c Turbidimetric Immunoassay reagent is meant for the quantitative determination of HbA1c in human blood. It has a reaction time of five minutes at 37°C and reading end point at 600 nm.

The Stat Profile Prime cell culture analyzer combines the revolutionary micro-electronics of the consumer world with Nova Biomedical’s innovative MicroSensor Card technology for a smaller, faster, less expensive analyzer.

LINKXPRESS COM

RANDOX LABORATORIES

LMI-11-23 201

Cont’d from cover

LMI-11-23 202

NOVA BIOMEDICAL

LMI-11-23 203

Predicting Diabetic Kidney Failure

ever study, researchers have identified a new predictive marker in the urine that identifies these patients at an early stage. This discovery holds significant implications, given that 90% of diabetes patients with low levels of albumin in their urine remain at heightened risk. Researchers from UT Health San Antonio (San Antonio, TX, USA; www.uthscsa.edu) have discovered that the levels of adenine, a metabolite originating in the kidney, serve as predictive and causative biomarkers for impending progressive kidney failure in diabetes patients. Metabolites are small molecules generated in response to metabolism. They can either drive cells towards a healthy state or a disease state. This breakthrough opens avenues for clinical testing to identify, five to ten years prior to kidney failure, patients who are at risk. Importantly, the research team identified a specific small molecule that can inhibit the main pathway of endogenous adenine production in the body. This therapeutic drug decreased kid-

BIOLABO GROUP

ney adenine levels in mice with type 2 diabetes. The researchers studied over 1,200 diabetes patients across three global research cohorts, consistently finding a correlation between elevated urine adenine levels and a heightened risk of kidney failure. UT Health San Antonio has perfected a spatial metabolomics technique on kidney biopsies from human patients that enables the identification of adenine and other small molecule locations within kidney tissues. The team detected endogenous adenine around scarred blood vessels in the kidney and around tubular-shaped kidney cells that were undergoing destruction. The finding that elevated adenine levels are also linked to all-cause mortality in study participants implies that the metabolite may influence other bodily regions. Although the measurement of urine adenine presents challenges, the Center for Precision Medicine at UT Health San Antonio has devised a robust and sensitive method to accurately measure urine adenine levels in patients.

Image: Metabolite in urine can predict diabetic kidney failure 5-10 years early (Photo courtesy of Tom Schoumakers, Shutterstock.com)

“It’s a very difficult technique, and it took us several years to develop a method where we combine high resolution of the geography of the kidney with mass spectrometry analysis to look at the metabolites,” said the senior study author, Kumar Sharma, MD. “What we’re hoping is that by identifying patients early in their course and with new therapies targeting adenine and kidney scarring, we can block kidney disease or extend the life of the kidney much longer.”

Breakthrough Device Detects DNA with 100-Fold Greater Sensitivity

raditional DNA detection methods are like searching for a needle in a haystack, given that there are many other molecules in a sample that are not the target DNA and can interfere with the result. Now, a new method for DNA detection offers 100-fold greater sensitivity than traditional methods, paving the way for faster disease detection at the point of care. In the new DNA detection method developed by researchers at the University of Massachusetts Amherst (Amherst, MA, USA; www.umass.edu), the test sample is placed within an alternating electric field, allowing the DNA strands to "dance." Each strand moves with its own unique

frequency of oscillation. Researchers can then examine the sample to find a molecule that moves just like the DNA they're looking for, making it easy to identify even when present in extremely low concentrations. The implications for this groundbreaking method are enormous, particularly for early diagnosis of diseases. Because of its high sensitivity, the test can identify diseases much sooner in their progression, which can be critical for treatment. Moreover, the electric-based method yields results in minutes rather than days, weeks, or months, making it ideal for point-of-care settings. Additionally, the technology is highly portable, resembling the size of a blood sugar

Image: This device detects DNA with a 100-fold greater sensitivity than traditional methods (Photo courtesy of UMass Amherst)

monitoring device, which has the potential to make a substantial impact on global health. “Everyone wants to detect the DNA at a low concentration with a high sensitivity. And we Cont’d on page 7 LabMedica International November/2023

To view this issue in interactive digital magazine format visit www.LabMedica.com

LabMedica International

POC Test Diagnosis Parkinson’s in 8 Minutes Cont’d from cover

alpha-synuclein. Moreover, new data indicates that tests for alpha-synuclein can help distinguish between people with PD and those without, making early identification of at-risk individuals possible. These findings underscore the significant role that alpha-synuclein plays both in classifying specific subgroups of Parkinson’s patients and in identifying potential groups at risk based on this biomarker. Now, the world’s first rapid, point-of-care, non-invasive diagnostic assay can detect abnormal alpha-synuclein using a single tear drop. The revolutionary new test developed by AXIM Biotechnologies (San Diego, CA, USA; www.aximbiotech.com) is user-friendly, affordable, and can be performed right at the point of care. While earlier research showed that α-synuclein in its aggregated form can be found in tears, the methods used for collecting tears were cumbersome and outdated. For instance, the Schirmer Strip method was used to collect tears, which were then immediately frozen at very low temperatures before being sent to a lab. There, a 30-minute centrifugation was performed before the total protein content could be analyzed using complicated equipment. This older approach was not quick, simple, and cost-effective. Unlike older methods, AXIM’s test does not require spinal taps, freezing samples, or lab processing. The assay uses a small drop of tear fluid and can be conducted in a medical office, with results available in under 10 minutes using a compact reader. Additionally, research has demonstrated that lactoferrin content is lower in PD patients. AXIM has already brought a lactoferrin test to market, which can be used alongside this new alpha-synuclein test.

Breakthrough Device Detects DNA with 100-Fold Greater Sensitivity Cont’d from page 6

just developed this method to improve the sensitivity by about 100 times with no cost,” said Jinglei Ping, lead author of the paper that appeared in Proceedings of the National Academy of Sciences (PNAS). “The nano-mechanoelectrical approach can be also integrated with other bioengineering technologies, like CRISPR, to elucidate nucleic acid signaling pathways, comprehend disease mechanisms, identify novel drug targets and create personalized treatment strategies, including microRNA-targeted therapies.”

LabMedica International November/2023

“With this new assay, AXIM has immediately become a stakeholder in the Parkinson’s Disease community and through this breakthrough, we are making possible new paradigms for better clinical care, including earlier screening and diagnosis, targeted treatments, and faster, cheaper drug development,” said John Huemoeller II, CEO of AXIM Biotechnologies. “This is just the beginning for AXIM in this arena, but I am convinced when pharmaceutical companies, foundations and neurologists see how our solution can better help diagnose Parkinson’s Disease in such an expedited and affordable way, we will be at the forefront of PD research, enabling both researchers and clinicians a brand-new tool in the fight against PD.”

Image: AXIM is also marketing a lactoferrin assay that can be used in conjunction with the new Synuclein test (Photo courtesy of AXIM)

Cystatin C FS

VISIT US AT

2023

Hall 3 • F80

Gold standard for early kidney disease diagnosis

· Overcomes the creatinine blind range and detects early decrease of GFR · Recommended by KDIGO and NICE to estimate kidney function · Outstanding performance and superior correlation with nephelometry · Excellent onboard and calibration stability of up to 12 weeks

DiaSys. Total confidence in patient results. www.diasys-diagnostics.com

LINKXPRESS RZ_Anzeige_LabMedica_CystatinC_141x185_engl_231009.indd 1 COM

LMI-11-23 107

09.10.23 14:51

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

HEMOSTASIS TESTING SYSTEM WERFEN

HBA1C ANALYZER CARETIUM

HIGH-DENSITY LIPOPROTEIN CHOLESTEROL ASSAY DIASYS DIAGNOSTIC SYSTEMS

The ACL TOP 550 CTS hemostasis testing system offers advanced automation and quality management, for routine to specialty assays. Designed for mid- to high-volume clinical laboratories, including those with lab automation tracks.

The T9 HbA1c analyzer offers excellent variant detection capabilities and features auto puncture sampling loading. It comes with a color touch screen, STAT mode and built-in barcode scanner.

HDL-c direct FS is a homogenous assay for direct determination of High-Density Lipoprotein Cholesterol (HDL-C). The high-quality reagent manufactured in Germany offers long calibration and onboard stability of up to four months.

LINKXPRESS COM

LMI-11-23 204

LMI-11-23 205

LMI-11-23 206

New Test Detects Hard-to-Find Cervical Cancers

ervical cancer is the fourth most common cancer in women, especially in lower- and middle-income countries. A particular type of cervical cancer called cervical adenocarcinoma (ADC), which often goes undetected by Pap tests, accounts for up to a quarter of all cervical cancer cases. The Pap test, a method where pathologists examine tissue samples for abnormal cells, has successfully reduced the occurrence of cervical squamous cell cancer over the past sixty years. However, ADC remains a challenge to detect with this method, leading to higher mortality rates compared to the more common squamous cell cancer. More recently, human papillomavirus (HPV) testing has become a standard cervical cancer screening tool alongside the Pap test. HPV is responsible for nearly all cases of cervical cancer. While there are over 100 types of HPV, three particular types—HPV 16, 18, and 45—account for more than 70% of all cervical cancer cases, with over 90% of ADC cases linked to them. Current HPV tests cover these three types, helping identify women at high risk of cervical cancer. Despite the effectiveness of vaccines like Gardasil-9, which protects against nine HPV types, many older women are

VISIT US AT

2023

Hall 1 • F01-2

MAST CARBA PAcE ®

Rapid, simple, cost effective carbapenemase detection

Results in <10 minutes

LMI-11-23 108

Image: The new test detects a type of cervical cancer that Pap tests often miss (Photo courtesy of MECC)

ineligible for vaccination. Consequently, screening and treatment remain vital for cervical cancer prevention for generations to come. Scientists at Montefiore Einstein Cancer Center (MECC, New York, NY, USA; www.montefiore.org) have developed an innovative test for detecting ADC and its precursor lesions known as adenocarcinoma in situ (AIS), which often progress to ADC. This MECC-designed HPV test evaluates HPV 16, 18, and 45 using a unique approach focused on methylation levels. Methylation, the addition of methyl (CH3) groups to specific DNA regions, is a common process in DNA, both viral and human, and plays a crucial role in altering gene expression. To develop this test, the researchers examined methylation levels in cervical tissue samples from 1,400 women who had undergone cervical cancer screening before 2014, with known cervical cancer status. They analyzed the HPVs present in the cytological samples, calculating methylation percentages for 35 different viral-genome sites. Each sample received a final "methylation score" based on the average methylation percentage across these 35 sites. They found that women with methylation scores in the top 25% had a significantly higher likelihood of developing either ADC or AIS. The findings were published on September 7, 2023 in the Journal of the National Cancer Institute (JNCI). "The advent of next-generation genetic testing has opened up opportunities for us to more accurately detect oncogenic HPV strains and patterns in the genomes that correspond with the development of AIS and ADC," said Robert D. Burk, M.D., who co-led the study. "Our findings, if confirmed by clinical trials, suggest that women with a high methylation score may benefit from colposcopy and specialized tissue evaluation, beyond just a Pap test, which could lead to early diagnosis and treatment for ADC or the removal of AIS lesions before they develop into ADC." LabMedica International November/2023

New flexible and fully automated solution Fast and easy pre-analytical protocol, no centrifugation needed

HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST > Stool Antigen fully automated detection VISIT US AT • Simple protocol with results in 1 hour. • On-demand testing, 1 monotest = 1 reportable test. • Method based upon antigen capture using monoclonal antibodies.

2023

Hall 3 • A30

• Individual quality control per monotest, no need for additional controls or calibrations. • Objective method with excellent diagnostic sensitivity and specificity.

0123

info@vircell.com

LINKXPRESS COM

LMI-11-23 109

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

AUTO HEMATOLOGY ANALYZER

D-DIMER TEST DXGEN

SEMI-AUTOMATED ELISA MICROSTRIP READER AWARENESS TECHNOLOGY, INC.

The Atellica HEMA 570/580 are fully automated, high-volume hematology analyzers sharing fast throughput and an identical footprint, intended for pairing with advanced informatics and automation solution for various workflow needs.

Epithod 616 D-Dimer Kit is an IVD test for the rapid and quantitative measurement of the fibrin degradation product D-Dimer in plasma. It has an assay time of less than three minutes and a detection time of five seconds.

The Stat Fax 4700 ELISA microstrip reader is ideal for reading ELISA microwell strips in laboratories and institutions where small runs of ELISA assays are routine. The robust instrument is factory calibrated and maintenance free.

LINKXPRESS COM

SIEMENS HEALTHINEERS - LABORATORY DIAGNOSTICS

LMI-11-23 207

LMI-11-23 208

LMI-11-23 209

Blood Test Predicts Osteoporosis

Cont’d from cover

sequences. The standard test for osteoporosis, known as dual-energy X-ray absorptiometry, often fails to detect the condition until substantial bone loss has occurred. But in the near future, people may be able to go to their doctor’s office for a simple fingerprick blood test to find out if they are genetically predisposed to developing osteoporosis. Researchers at the University of Rovira i Virgili (Tarragona, Spain; www.urv.cat) are developing a platform that uses SNPs—single nucle-

VISIT US AT

2023

Hall 3 • F06

Image: A new fingerprick test assesses osteoporosis risk based on genomic variants (Photo courtesy of 123RF)

otide polymorphisms—to predict not only the risk of osteoporosis but also other health conditions like malaria and cardiovascular disease. The platform employs a unique electrode array device that screenprints DNA sequences corresponding to different SNP types as gold dots. The biosensor then calculates a risk score by analyzing a blend of five specific SNPs that are crucial for assessing osteoporosis risk. This is based on a wide-ranging genetic analysis involving about 50,000 people who also had known family histories and lifestyle factors. The test is quick, taking roughly 15 minutes, and each SNP analyzed costs about 50 cents for reagents. The researchers have bigger plans for the device, aiming to explore other types of biomarkers such as proteins and different RNA forms, all from a single fingerprick blood sample. Current projects using this electrode array are focusing on identifying 14 high-risk HPV genotypes from a vaginal swab as a prescreening measure for women in underdeveloped countries. The platform is also being studied for its capability to quickly triage patients showing signs of bacterial infections. In such cases, the device could identify both the disease, such as malaria or HIV, and any antibiotic resistance to guide medication choices. The device is highly versatile and can be adapted for various health conditions. Additionally, new research has begun to use both SNPs and proteins in a single blood sample to gauge the risk of developing cardiovascular diseases. “There is a whole range of diseases that can be detected at an early... enough [stage] to intervene and treat them correctly,” said Ciara K. O’Sullivan, Ph.D., research professor at the University of Rovira i Virgili. LINKXPRESS COM

LMI-11-23 110

LabMedica International November/2023

S U CA 08 IN EDI 3 A JO M #0 AT ND A ST

Complete QC Solutions For Results You Can Trust

INTRODUCING THE NEW ACUSERA TRUE THIRD PARTY CONTROLS

ACTIVE B12

ANTI MÜLLERIAN

BONE MARKERS

ULTRA-LOW PSA

BRAIN NATRIURETIC

SERUM INDICES

XANTHOCHROMIA

randox.com marketing@randox.com Visit store.randox.com to buy directly from Randox today LINKXPRESS COM

LMI-11-23 111

Product availability may vary from country to country. Some products may be for Research use Only. For more information on product application and availability, please contact your local Randox Representative.

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

THYROID ELISA REAGENT

ANTI-PROTEINASE 3 EIA KIT

HDL SUBFRACTIONS KIT

T082 is an enzyme linked immunosorbent assay for the quantitative determination of thyroglobulin in human serum. Serum thyroglobulin measurement is primarily used as a tumor marker in thyroid carcinoma.

MASTAZYME PR3 and -MPO ELISA are designed for detection and quantification of specific antibodies against proteinase 3 and myeloperoxidase respectively in serum and plasma. The assay is intended for in-vitro diagnostic use only.

The Lipoprint HDL Subfractions Kit contains precast, ready to use polyacrylamide gel tubes and loading gel with lipophilic dye to pre-stain the lipoprotein bands. It contains all the reagents necessary to run 100 tests.

LINKXPRESS COM

VEDA LAB

MAST GROUP

LMI-11-23 210

LMI-11-23 211

QUANTIMETRIX

LMI-11-23 212

Genetic Test Could Help Select Best Treatment for Autoimmune Disease

Human – Veterinary – Bio-Threat Diagnostics / Research / Forensic

QuickProfile™ QuickStatus® Quicknostics® EnviroSafe™ Safe™

Your Partner For A Beeer Healthcare Infectious Diseases Drugs of Abuse

Cancer Markers

Cardiac Markers Hormones Veterinary Tests Oxidative Stress Bio-Threat Agents

Visit us at the US Pavillion

Hall 3 3D35-6 www.LumiQuick.com www.QuickProﬁleDOA.com sales@LumiQuick.com +1(408)855-0061 LINKXPRESS COM

LMI-11-23 112

nkylosing spondylitis (AS) is an autoimmune condition that is estimated to affect 1 in 200 people. It primarily causes inflammation in the spine, joints, and ligaments, leading to pain and stiffness. In extreme cases, some of the spinal bones may fuse together, causing a loss of spinal flexibility and a permanent hunched posture. The onset of symptoms is generally between the ages of 17 and 45. Individuals with AS often have other autoimmune issues, such as inflammation of the eyes, inflammatory bowel disease, and psoriasis. The initial treatment usually involves over-the-counter pain relievers like naproxen or ibuprofen, followed potentially by corticosteroid injections and even joint replacement surgery in certain cases. Another option for treating the inflammation is through biologics, lab-engineered protein-based treatments. Two types of biologics are available for treating AS, including one class known as IL-17 inhibitors, which target the interleukin-17 (IL-17) protein. However, determining which biologic will be effective for a given patient is currently a matter of trial and error, with biologics showing effectiveness only around 40% of the time. Using an ineffective biologic can be expensive, cause unwanted side effects, and allow the condition to deteriorate further. Now, the latest research sheds new light on the molecular processes involved in AS that could allow healthcare providers to do away with this guesswork while treating the condition A team of researchers from the OHSU School of Medicine (Portland, OR, USA; www.ohsu.edu) have discovered that a specific form of AS treatment works well in patients with a particular genetic mutation. AS does not have a single cause, with multiple genes associated with the condition. Specifically, about 72% of AS patients have a mutation in their CARD9 gene, responsible for producing proteins that contribute to the body's immune response. This mutation tends to make the CARD9 gene hyperactive, causing immune cells like neutrophils to become overactive, which may result in attacking healthy cells. In their study, the researchers first removed the CARD9 gene in mice used for autoimmune disease research and found that these genetically altered mice did not develop AS, establishing that the CARD9 gene plays a role in the disease. The researchers discovered that individuals with the mutated CARD9 genes had significantly higher levels of the IL-17 protein in their blood than those without the mutation. This led them to theorize that AS patients with this particular CARD9 mutation could be more responsive to IL-17 inhibitor biologics. The findings, published in the journal Cont’d on page 13 LabMedica International November/2023

To view this issue in interactive digital magazine format visit www.LabMedica.com

LabMedica International

Blood Test Detects Chronic Fatigue Syndrome at Over 90% Accuracy Cont’d from cover

for potential new treatments. Now, an international team of medical researchers claims to have created a simple test for diagnosing ME/CFS. Led by the University of Oxford (Oxford, UK; www.ox.ac.uk), the research team has developed a blood test for ME/CFS that has demonstrated a 91% accuracy rate. The team hypothesized that the underlying issue of ME/CFS may be related to cellular energy function. To test this, they focused on examining peripheral blood mononuclear cells—cells with a single, round nucleus, like T cells, monocytes, and lymphocytes. Previous studies have hinted at the involvement of these cells in ME/CFS. Since no existing test could measure their energy function, researchers turned to an unconventional tool: Raman spectroscopy, commonly used in chemistry to identify molecular structures based on their vibrational characteristics. Speculating that the vibrations in single cells might differ between ME/ CFS patients and others, the scientists examined blood samples from 61 affected individuals and 16 controls. They noted a significant variation between the two groups. Encouraged by these findings, they designed an AI application capable of handling largescale data analysis. When tested on 2,000 cells from 98 patients, the system proved to be 91% accurate. The group is optimistic about their discovery and plans to expand their research with larger sample sizes. The introduction of this blood test marks a pivotal advancement in diagnosing and managing ME/CFS more effectively. The research was published on August 31, 2023 in the journal Advanced Science.

Image: The blood cell-based diagnostic test detects myalgic encephalomyelitis/chronic fatigue syndrome (Photo courtesy of 123RF)

Genetic Test Could Help Select Best Treatment for Autoimmune Disease Cont’d from page 12

Annals of the Rheumatic Diseases, could pave the way for more precise and effective treatments for AS. Currently, the team is collaborating with clinicians to further investigate this connection in people with AS. If subsequent studies confirm these initial findings, healthcare providers might eventually use genetic tests to identify patients with the CARD9 gene mutation. “This is the first time research has shown that we might be able to use genetic markers to determine which therapy ankylosing spondylitis patients should receive,” said the study’s senior researcher, Ruth Napier, Ph.D. “These promising findings are encouraging. This is the first time I can say that I’m on the cusp of making a difference for patients with ankylosing spondylitis who seek relief.”

LabMedica International November/2023

LINKXPRESS COM

LMI-11-23 113

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

COVID-19 RAPID TEST SEKISUI DIAGNOSTICS

AUTOMATIC ELECTROLYTE ANALYZER

CLIA ANALYZER

URIT MEDICAL ELECTRONIC

SNIBE

The OSOM COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARSCoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens.

The URIT-910C Plus is an automatic electrolyte analyzer that offers friendly operation and features intelligent bubble detection technology. It also offers the option of individual reagent and auto sampling tray (25 positions).

The MAGLUMI X6 is a flexible CLIA solution for medium/high-volume laboratories with a throughput of up to 450 T/H. It offers a flexible sample position design with on-board capability from 112 to 412 samples.

LINKXPRESS COM

LMI-11-23 213

VISIT US AT

2023

LMI-11-23 214

LMI-11-23 215

Microbiology Reporting System Advances Infectious Disease Management

Hall 1 • E26

Cont’d from cover

against AMR. Now, a cutting-edge decision-supporting clinical tool is bridging this gap by utilizing modern technologies for precise, rapid, and effective patient care in the digital age. Arkstone Medical Solutions (Boca Raton, FL, USA; www.arkstonemedical.com) has introduced a groundbreaking advancement— the OneChoice report for microbiology lab results. Building on the success of its molecular lab results OneChoice report, which has benefited countless patients and earned the trust of numerous healthcare providers, Arkstone has extended its revolutionary technology to the realm of microbiology. The OneChoice report represents a transformative step in infectious disease treatment. Unlike traditional microbiology lab reports that present raw text data for interpretation, Arkstone’s OneChoice decision engine analyzes a range of factors to provide precision-guided treatment recommendations. By harnessing advanced artificial intelligence and a deep understanding of infectious diseases, Arkstone empowers healthcare providers with personalized medicine tailored to each patient’s specific requirements. At the heart of the OneChoice report is the PathFinder system, which identifies potentially pathogenic organisms within samples, laying the foundation for more accurate treatment decisions. This innovative tool considers various sensitivities tested in the lab and evaluates their relevance based on the source of the sample. Additionally, the report features the MedsMatrix, a visual table that highlights effective drugs alongside considerations like allergies or pregnancy status. The report also offers OneChoice Plus—an interactive online version accessed through a QR code on each report. OneChoice Plus equips clinicians with

LINKXPRESS COM

LMI-11-23 114

Image: The OneChoice report for microbiology lab results empowers clinicians to provide optimal care (Photo courtesy of Arkstone)

a comprehensive toolkit for efficient patient care management. It provides tools for dosage adjustments, drug references, drug interaction checks, GFR, and CrCL calculators—all at the fingertips of physicians. Furthermore, OneChoice Plus offers translations in multiple languages, facilitating clear communication and comprehension for healthcare providers and patients across the world. “We are thrilled to introduce these groundbreaking advancements to our OneChoice report,” says Dr. Ari Frenkel, infectious disease specialist, and Co-Founder & Chief Science Officer of Arkstone. “Precision-guided medicine is the future of infectious disease treatment, and our latest innovations will empower clinicians to provide optimal care while upholding antimicrobial stewardship principles.” “With the launch of the OneChoice report for microbiology lab results, Arkstone is poised to make an even greater impact on the healthcare landscape,” said Dave Gross, Co-Founder & CTO of Arkstone. “Our commitment to evidence-based information and continuous innovation has positioned us as the trusted partner for healthcare providers worldwide. By expanding our technology to microbiology, we’re enabling healthcare providers to make more informed decisions and ultimately improve patient outcomes.” LabMedica International November/2023

New Generation Hospital Glucose/Ketone Meter VISIT US AT

2023

Hall 3 • C16-2

Only glucose meter FDA-cleared for use with critically ill patients No known clinical interferences 8,000 medications investigated • Proven in a study of 1,698 critically ill patients with 257 specific medical conditions • Glucose accuracy proven in over 200 publications •

Measures blood ketone with the same meter

POC ketone testing enables fast response to DKA • ADA, Diabetes UK, and others mandate blood ketone testing, not urine ketone testing, when glucose >11 mmol/L • Measures B-hydroxybutyrate, the recommended ketone for hyperglycemia and DKA analyses •

StatStrip Hospital Connectivity Meter

New meter features

Linux® advanced cybersecurity • Rugged external meter casing • Wireless charging • RFID, Bar Code, or touchscreen data entry •

StatStrip Xpress®2 Limited Connectivity Meter

LINKXPRESS COM

LMI-11-23 115

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

QUICKPROFILE DOA WIPE TEST LUMIQUICK DIAGNOSTICS

FECAL OCCULT BLOOD IMMUNOCHEMISTRY ANALYZER SENTINEL DIAGNOSTICS

TIME RESOLVED FLUORESCENCE IMMUNOASSAY ANALYZER AGAPPE

The QuickProfile DOA Wipe Test is intended for the qualitative assessment of drugs of abuse in environmental samples. The simple-to-use test is available as a single or multi test for fentanyl, xylazine, opiates and other drugs.

The SENTiFIT 800 Analyzer is a fully automated high throughput system for fecal testing able to meet the needs of colorectal cancer (CRC) screening organizations and laboratories with a high volume of fecal tests.

The Mispa Revo Plus is a time-resolved fluorescence immunoassay analyzer. The compact and portable device uses antigens or antibodies to determine the concentration of specific analytes in serum, plasma, and whole blood.

LINKXPRESS COM

LMI-11-23 216

LMI-11-23 217

LMI-11-23 218

Image: Researchers have made progress in cell-free DNA for early diagnosis of preeclampsia (Photo courtesy of 123RF)

Digital PCR Test Enables More Accurate and Earlier Diagnosis of Preeclampsia in Pregnant Women dentifying preeclampsia early on can greatly assist obstetricians and gynecologists in advising the use of low-dose aspirin to help prevent the high blood pressure associated with this condition. The American Society of Obstetrics and Gynecology suggests that treatment ideally starts before six weeks of pregnancy in those who are at risk. Currently, the only way to assess risk is through clinical and demographic indicators, such as age and medical history. Past attempts to discover reliable biomarkers like RNA signatures or proteomics have not been very successful. Researchers at the University of Hong Kong (Hong Kong, PRC; www.hku.hk) have now made significant progress in creating a more accurate test for detecting preeclampsia in pregnant individuals. Their latest data shows that digital PCR can effectively identify long fragments of cell-free DNA (cfDNA) that can differentiate between those developing preeclampsia and those with normal pregnancies. This research, which was published earlier this month in the journal Prenatal Diagnosis, builds on the team's previous work, which indicated that different sizes of DNA fragments could be a sign of incipient

Cont’d on page 18

LabMedica International November/2023 LINKXPRESS COM

LMI-11-23 116

Acute Care Diagnostics

The Intelligent Analyzer GEM Premier 5000 blood gas testing system provides automated quality assurance with every whole-blood* sample. Now with next-generation Intelligent Quality Management (iQM2), featuring IntraSpect™ technology, potential errors are detected not only before and after, but also during sample analysis, along with real-time correction and documentation. Plus, it’s simple—just change the all-in-one GEM PAK once a month. So regardless of testing location or point-of-care operator, quality results and compliance are assured with every sample.

Real-time assurance and advanced simplicity. Now that’s intelligent. For more information, contact your local Werfen representative. werfen.com

LINKXPRESS COM

LMI-11-23 117

*Heparinized. GEM, Premier and iQM are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. The Werfen logo is a trademark of Werfen and may be registered in the Patent and Trademark Offices of jurisdictions throughout the world. ©2021 Instrumentation Laboratory. All rights reserved.

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

MATERNAL SCREENING BI-LEVEL CONTROLS

AUTOMATIC BLOOD CULTURE SYSTEM

ZIKA/DENGUE/CHIKUNGUNYA TEST

Ansh Labs Maternal Serum (MS) Bi-Level Controls are quality controls intended to monitor accuracy and reproducibility of testing methods for determination of AFP, Inhibin A, free beta hCG, Estriol, PAPP-A, intact hCG in human serum.

The BC60 automatic blood culture system features a stable temperature control system and reliable vibrating module, which significantly shortens the detection time of positive results and reduces the false positive rate.

Zika Virus/Dengue Virus/Chikungunya Virus Real-Time PCR Kit is intended for the in vitro qualitative detection of RNA from dengue, chikungunya, and Zika viruses in human serum, whole blood (EDTA), cerebrospinal fluid (CSF).

LINKXPRESS COM

ANSH LABS

LMI-11-23 219

AUTOBIO DIAGNOSTICS

LMI-11-23 220

DISCOVER MORE.

BIOPERFECTUS TECHNOLOGIES

LMI-11-23 221

Digital PCR Test Enables More Accurate and Earlier Diagnosis of Preeclampsia in Pregnant Women Cont’d from page 16

odels All mwith our t e com stry bes indu YEAR 10 ranty! war

A 57 year tradition of excellence in Europe backed by the support and service of a partner you trust. •Premium microscopes since 1966 •Designed and engineered in the Netherlands, stocked in the US •Solid reputation for quality and reliability throughout Europe •Extensive line includes solutions for all educational, clinical, research, and industrial applications. Globe Scientific | Euromex microscopes are supported by Globe Scientific’s extensive pre-sale training programs, personal consultation, after-sales technical support, and responsive customer service.

globescientific.com • (800) 394-4562 • mail@globescientific.com LINKXPRESS COM

LMI-11-23 118

preeclampsia. Although this is preliminary data, the scientists believe this could evolve into a clinically useful test. The root cause of preeclampsia is still not fully understood, but abnormal formation of the placenta and placental stress are thought to play a role. Since the first discovery of cfDNA in maternal plasma back in 1997, changes in cfDNA levels in preeclamptic pregnancies have been noted. The researchers suspected that unique patterns of DNA fragmentation, which they had earlier linked with fetal abnormalities and cancers, could also be found in pregnancies affected by preeclampsia. Initial findings, using a technique called SMRT-sequencing, supported this hypothesis, showing a distinct ctDNA size profile, particularly a reduction in the percentage of long cell-free DNA, in pregnancies with preeclampsia. The team's next aim was to adapt these findings into a more cost-effective and simpler test. They used droplet digital PCR (ddPCR) with the QX One instrument from Bio-Rad Technologies. For their study, plasma samples from 10 preeclamptic and 16 normal pregnancies were analyzed. The researchers developed two initial ddPCR assays targeting a housekeeping gene called VCP, in fragment sizes of over 533 and 1,001 base pairs, which were the main sizes analyzed in their earlier sequencing work. Using cfDNA sequencing data from their earlier study, the researchers also performed in silico dPCR simulations in order to determine the optimal parameters and the best differentiating power between control and preeclamptic pregnancies. This led to the development of another assay aimed at the long interspersed nuclear element-1 (LINE-1), a run of about 1,600 repeat regions across the genome, targeting fragments longer than 170 base pairs. The researchers found that both the initial assays and the LINE-1 assay could differentiate the preeclamptic samples from the healthy ones, with the LINE-1 assay showing greater accuracy in differentiation. The breadth of the LINE-1 assay also resulted in a 1,600-fold enrichment of target fragments compared to the single-copy gene assays which enabled much smaller DNA inputs. Further work is needed, including validation studies with larger sample sizes, and studies to determine how early in pregnancy this test could be effective. The team also plans to investigate any factors that might influence the percentage of long cfDNA fragments in the plasma of pregnant individuals. LabMedica International November/2023

To view this issue in interactive digital magazine format visit www.LabMedica.com

LabMedica International

Rapid AST Directly from Blood Cultures to Combat Bloodstream Infection

he presence of living bacteria in the bloodstream, known as bacteremia, can lead to serious conditions like bloodstream infections (BSIs) and sepsis, which can often be fatal. Quickly prescribing the right antibiotics is crucial for reducing the risk of death in patients with BSIs. Traditional methods for antimicrobial susceptibility testing (AST) to guide these prescriptions can take a long time, leaving doctors to depend mostly on their own expertise. To tackle this issue, researchers have come up with a specialized microfluidic chip called the BSI-AST chip. This chip can extract bacteria and perform AST directly from positive blood cultures in under 3.5 hours, offering a faster and more effective approach to managing BSIs. Existing AST techniques take a minimum of two days to provide results after a blood culture tests positive for bacteria. This delay pushes healthcare providers to prescribe broad-spectrum antibiotics without waiting for test results, which could worsen the patient's condition and contribute to antibiotic resistance. In response to this urgent need, a group of researchers, Image: On-chip pretreatment and rapid AST including scientists from the Chinese Academy of Sciences (CAS, Beijing, China; www. based directly on positive blood cultures cas.cn), have developed the BSI-AST chip. This chip is capable of isolating bacteria from a (Photo courtesy of Liu Yang) positive blood culture in just 10 minutes, and completing the AST in an additional three hours. In VISIT US AT a proof-of-concept experiment, the chip successfully performed AST 2023 on artificial positive blood cultures Hall 1 • A64 containing E. coli, and was tested against 18 different antibiotics, all within less than 3.5 hours. The BSI-AST chip was also tested with actual clinical positive blood cultures and showed a 93.3% agreement with conventional clinical testing methods. This chip's quick and reliable results demonstrate its immense potential for use in clinical settings. What sets this chip apart is that it can operate directly on positive blood cultures without needing an additional subculture step. This is achieved through the introduction of a separating gel into the microfluidic chip for the first time. Centrifugal microfluidic enrichment technology also played a key role. Additionally, the chip can perform multiple analyses simultaneously through antibiotic drying and parallel array techniques, helping doctors make better antibiotic choices for their BSI patients. The chip can also be easily integrated with Clinical Antimicrobial Susceptibility Test Ramanometry (CAST-R), another invention from the same team, to provide a streamlined solution for sample pretreatment. “Rapid AST in blood culture is significant for patients with clinical sepsis and has the potential to save lives,” said Prof. Cheng Yongqiang, the study’s corresponding author, who also noted the role of such technology in combating the serious threat of microbial resistance to humanity.

LabMedica International November/2023

LINKXPRESS COM

LMI-11-23 119

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

RUBELLA VIRUS ANTIBODY TEST

NEAR-PATIENT TESTING PLATFORM

AUTOMATIC SAMPLE PROCESSOR

The OnSite Rubella IgG/IgM Rapid Test is a lateral flow immunoassay for the semi-quantitative detection and differentiation of antibodies (IgG and IgM) to rubella virus in human serum, plasma, or whole blood.

FINDER is a near-patient testing platform powered by digital microfluidics specifically designed to address the need for tests requiring low blood volume. It has a turnaround time of about 15 minutes after sample introduction.

The LBP-2524 automatic sample processor is designed for the pre-processing of cervical cells and sputum specimens. This pathology machine adopts a touch-screen operating system and a high-precision optical positioning system

LINKXPRESS COM

CTK BIOTECH

LMI-11-23 222

BAEBIES

LMI-11-23 223

DAAN GENE

LMI-11-23 224

PCR-Based Endometrial Cancer Detection Test to Prevent Missed Diagnoses

ndometrial cancer is the most frequently diagnosed gynecologic cancer. In 2020, around 417,367 individuals received an endometrial cancer diagnosis. One out 10 women experiencing abnormal bleeding during their lifetimes will need invasive specialist biopsy procedures to rule out endometrial cancer. Previous research has identified specific gene hypermethylation as a potential biomarker for endometrial cancer detection. This has now paved the way for a minimally invasive test that identifies methylated biomarkers, indicating gene repression linked to malignancy. By utilizing the widely accepted pap smear or HPV sampling approach, this molecular test offers huge potential as a supplementary tool for assisting in endometrial cancer diagnosis right at the clinic. INEX Innovate (Singapore; www.inex. sg) has launched epiHERA, the company’s early endometrial cancer detection technology, powered by a cutting-edge PCR test that is designed to detect epigenetic changes in genes associated with the presence of endometrial cancer. The epiHERA testing process starts with a simple cervical swab, similar to the sample collection method employed in cervical cancer screening. Subsequent steps involve genomic DNA extraction and bisulfite conversion. The final phase of the test entails real-time PCR analysis, focusing on the hypermethylated CDO1 and CELF4 genes. This streamlined process takes about six hours to be completed. epiHERA addresses a critical gap in existing diagnostics by promoting equitable access to testing for vulnerable women. Its innovative methodology streamlines sample collection,

LINKXPRESS COM

LMI-11-23 120

Image: The new molecular test is designed to use Pap Smear for early endometrial cancer detection (Photo courtesy of Freepik)

significantly reducing turnaround time from weeks to days. Leveraging the scalability of molecular PCR testing ensures widespread availability, thereby increasing epiHERA's impact in the field of women's health. epiHERA has shown promising results in validation studies. Researchers can now access epiHERA for validation within their unique population cohorts, facilitating diverse applications and a comprehensive understanding of its efficacy. “The launch of epiHERA is a testament not only to a shift in endometrial cancer detection but also underscores INEX Innovate's unwavering dedication to innovative solutions that enable timely interventions and improved patient outcomes,” said Kane Black, CEO of INEX Innovate. “epiHERA is the latest test launched by our team as we continue our path to being Asia’s pre-eminent women’s life science platform, and has received significant interest from clinicians and lab operators in the region. The launch comes at an exciting time of growth for the company on the back of recent acquisitions in the area as we expand both technology pipelines and geographically across the region.”

LabMedica International November/2023

We build partnerships that matter

VISIT US AT

2023

Hall 1 • D59

At SEKISUI Diagnostics, what matters to you matters to us. Our whole purpose is to partner with you to provide intelligent solutions that enable you to make a timely difference. Because we both understand that there is a patient behind every answer—and that’s what matters most. For more information about our assays and systems, please visit sekisuidiagnostics.com or email us at questions@sekisui-dx.com Clinical Chemistry • Point-of-Care • Enzymes • Pre-Analytic Systems

LMI-11-23 121

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

3-PART AUTO HEMATOLOGY ANALYZER

COLORIMETRIC ASSAY

AUTOMATED IFA PROCESSOR

The DH20 is an economical, compact and efficient 3-part auto hematology analyzer that is user-friendly and offers more clinical parameters. It requires only 9ul of sample volume and includes an optional RF card and barcode function.

The MYCOFAST RevolutioN 2 is a colorimetric assay designed for detection, enumeration, identification and antibiotic susceptibility determination of Ureaplasma urealyticum and Mycoplasma hominis from urogenital specimens.

The IF Sprinter is a solution for fully automated processing of immunofluorescence tests for small and medium sample volumes. It performs identification, dilution, and transfer of samples, as well as washing and incubation steps.

LINKXPRESS COM

DYMIND BIOTECHNOLOGY

LMI-11-23 225

ELITECHGROUP

LMI-11-23 226

EUROIMMUN

LMI-11-23 227

Blood Test Significantly Improves Cancer Detection by Leveraging RNA “Dark Matter”

etecting cancer in its early stages is vital for effective treatment, creating the need for innovative and non-invasive diagnostic methods. Liquid biopsies, which involve a simple blood draw, are emerging as a technology for non-invasive cancer testing through DNA or RNA sequencing of blood samples. Researchers are harnessing signals from RNA "dark matter," a lesser-explored genome area, to develop more accurate and powerful liquid biopsy techniques. Now, new research reveals that this genetic material is present in the blood of individuals with cancer, and its identification can facilitate the early diagnosis of specific cancer types like pancreatic, lung, and esophageal cancers. Researchers at UC Santa Cruz (Santa Cruz, CA, USA; www. ucsc.edu) have developed an RNA liquid biopsy platform that is capable of detecting both protein-coding RNA and RNA dark matter in blood samples. This approach significantly enhances the performance of liquid biopsies for cancer diagnosis. Unlike the prevalent focus on DNA-based liquid biopsies, this approach zeroes in on RNA "dark matter," particularly noncoding and repetitive RNA. Most of the human genome's three billion base pairs are transcribed into RNA, collectively termed the transcriptome. While RNA's primary

function is protein coding, 75% of the human genome generates noncoding RNA that doesn't code for proteins. A considerable portion of these noncoding RNAs originates from repetitive elements, some of which exit the cell Image: A new blood test for noncoding RNA of origin and enter improves cancer detection (Photo courtesy the bloodstream. of 123RF) Ordinarily, a healthy individual's blood contains minimal repetitive noncoding RNAs. However, the researchers at UC Santa Cruz demonstrated that even during the earliest cancer stages, many of these repetitive RNAs are secreted by cancer cells, serving as potent biomarkers for early-stage disease. The RNA liquid biopsy technology developed by the researchers employs "cell-free RNA" sequencing from patient blood samples to detect the presence of both protein-coding and repetitive noncoding RNA. The team has developed the COMPLETE-seq cell-free RNA sequencing and analysis platform that identifies repetitive noncoding RNAs which are usually overlooked. This approach analyzes the sample for all annotated transcriptome regions—tens of thousands of well-documented RNAs—as well as the five million noncoding repetitive elements that the researchers focus on. Other existing liquid biopsy tests have displayed limited sensitivity for early-stage cancers, sometimes missing up to 75% of stage I cancers due to their low biological signal linked to small tumor size. The novel research underscores that incorporating repetitive RNA into the liquid biopsy platform amplifies the biological signal, enhancing the performance of machine learning models in cancer identification. For instance, COMPLETE-seq enhanced the sensitivity for Cont’d on page 23

LINKXPRESS COM

LMI-11-23 122

LabMedica International November/2023

To view this issue in interactive digital magazine format visit www.LabMedica.com

LabMedica International

Celiac Disease Blood Test to Eliminate Painful Biopsies

here is still a controversy over whether it is possible to diagnose celiac disease in adults using only serology. Now, a study has found that a simple test for measuring the levels of anti-tissue transglutaminase IgA (tTG-IgA) in the blood could be used as a diagnostic threshold in predicting duodenal villous atrophy, a key feature of celiac disease. Researchers from the University of Salerno (Fisciano SA, Italy; www. unisa.it) conducted a study on a cohort of individuals suspected to have celiac disease. After certain exclusions, the final cohort included 436 individuals, comprising 296 women and 140 men, with an average age of 40. These participants hailed from various global regions, mostly Europe, followed by Asia, Oceania, and South America. Based on their symptoms, the participants were divided into three categories: those showing classical symptoms like anemia, weight loss, or diarrhea; those with atypical symptoms; and those who were suspected to have celiac disease based on family history or other associated autoimmune conditions. Duodenal tissue samples were collected from the participants via endoscopy and were assessed by local pathologists at 14 different sites. Additionally, tTG-IgA levels were measured in both local and central labs. A result was considered positive if tTG-IgA levels exceeded one time the upper limit of normal (ULN). Out of the cohort, 363 participants (or 83%) had tTG-IgA levels above the threshold, while 73 (or 17%) had levels below it. Among those with elevated tTG-IgA, 341 were confirmed to have celiac disease

through histological review, whereas 22 did not have the disease. Of the participants with low tTG-IgA, seven were false negatives with positive histology, and 66 were true negatives. Importantly, the study found that tTG-IgA concentrations that were 5, 10, or 15 times higher than the ULN offered the most reliable diagnostic accuracy, suggesting that 10 times the ULN could be a useful diagnostic threshold. This study validates the use of a blood test for diagnosing celiac disease in adults, similar to the "no-biopsy" approach currently used in children. The detailed findings of the study were published in The Lancet Gastroenterology & Hepatology. Image: Biopsy-free diagnosis of celiac disease in adults has shown promising results (Photo courtesy of Freepik)

Novel Blood Test Significantly Improves Cancer Detection by Leveraging RNA “Dark Matter”

Cont’d from page 22

identifying colorectal cancer to 91%. The study findings indicate the potential of this technology for identifying diverse cancer types. The team’s initial study focused on pancreatic cancer due to its critical need for early detection, given its unfavorable outcomes when detected late. Additionally, pancreatic cancer is understood to be driven by KRAS gene mutations, which is also a focus area of the research team. Following verification in pancreatic cancer, the researchers extended their investigations to various other cancers and plan to further explore a wide range of cancer types using samples across progressive cancer stages. Their ultimate goal is to develop an RNA liquid biopsy test for early detection of multiple cancers, utilizing

the wealth of information from repetitive RNAs to achieve precise and sensitive disease identification and diagnosis. This platform aspires not only to diagnose cancer at its earliest stages but also to guide tailored, individualized treatment strategies when cancer is most treatable. Moreover, the test's potential extends to identifying cancer recurrence and diagnosing other diseases altering the repetitive RNA landscape, such as Alzheimer's disease. “The value of our study is that we've now shown the potential of these repeat elements for diagnosing disease, so hopefully there'll be a lot of interest in leveraging repetitive RNAs to boost the sensitivity of these multi-cancer early detection tests,” said Daniel Kim, Assistant Professor of Biomolecular Engineering at UC Santa Cruz.

INTRODUCING OUR

VISIT US AT

NEW MICROPUMPS SILENT

PULSATION-FREE

RESPONSIVE

COMPACT

2023

Hall 8a • K09

PRECISE

The Lee Company’s new range of award winning piezoelectric disc pumps generate pressure and vacuum in a small, silent, vibration-free form factor.

MEDICA 3/9 Print Ad.indd 1

LabMedica International November/2023

LINKXPRESS COM

LMI-11-23 123

Learn more at theleeco.com/discpumps

10/16/23 11:41 AM

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

AUTOMATIC CLINICAL CHEMISTRY ANALYZER

LIPOPROTEIN (A) POC TEST

CENTRIFUGE TUBES

FUJIFILM EUROPE

EUROLYSER DIAGNOSTICA

GLOBE SCIENTIFIC

The DRI-CHEM NX700 is a high throughput automatic clinical chemistry analyzer accomodating five different samples simultaneously. It offers a high throughput of 190 tests/ hour, 28 colorimetric items and three electrolyte items.

The Lipoprotein (a) Test is a kinetic test based on a latex-immunoturbidimetric measurement for Lp(a) which is similar to low-density lipoprotein (LDL) in lipid composition but differs in protein profile.

Diamond Max centrifuge tubes are engineered to meet the demands of the most critical scientific work. Premium-grade materials and an automated, touch-free manufacturing process provide both performance and savings to users.

LINKXPRESS COM

LMI-11-23 228

LMI-11-23 229

LMI-11-23 230

Routine Genetic Testing Benefits Patients with Advanced Inherited Heart Muscle Disease ilated cardiomyopathy (DCM) is a condition where the heart muscle weakens, causing the heart to enlarge and reducing its ability to effectively pump blood throughout the body. It can develop at any age but is more common around the mid-40s. Symptoms include shortness of breath, fatigue, swollen legs and feet, and irregular heartbeat. In severe cases, it can lead to heart failure or sudden cardiac death due to abnormal heart rhythms. Genetic testing is a crucial tool to identify gene mutations that can cause inherited heart conditions like cardiomyopathy. Despite the knowledge that DCM often runs in families, genetic testing is seldom conducted on patients who have undergone heart transplants or received a left ventricular assist device (LVAD), a mechanical heart pump. Now, a multi-site, five-year study has demonstrated the benefits of routine genetic testing for patients with advanced disease from DCM and their at-risk family members. The DCM Precision Medicine Study, led by researchers at MedStar Health (Columbia, MD, USA; www.medstarhealth.org) and colleagues from across the U.S., investigated clinical and genetic data from 1,265 patients across 25 top academic heart failure and transplant programs in the U.S. These programs are part of the Dilated Cardiomyopathy Consortium. The study revealed that DCM patients with advanced heart disease, meaning those who had a heart transplant or an LVAD, were over twice as likely to carry a disease-causing mutation in a relevant DCM gene compared to those without advanced heart disease. “These study results validate the concept that routine genetic testing performed on these patients allows us to identify their family members who may be at risk of developing DCM and when early signs of disease do appear, we can begin earlier treatment in those family members, perhaps ultimately avoiding the need for either heart transplantation or mechanical circulatory support,” said Mark Hofmeyer, MD, medical director of the Advanced Heart Failure Intermediate Care Unit at MedStar Heart & Vascular institute at MedStar Washington Hospital Center and the first author of the DCM Precision Medicine study.

VISIT US AT

2023

Hall 3 • C26-6

LINKXPRESS COM

LMI-11-23 124

LabMedica International November/2023

To view this issue in interactive digital magazine format visit www.LabMedica.com

LabMedica International

Rapid Detection Technique to Improve Diagnostic Procedure for Bacterial Diseases

ipopolysaccharide (LPS) is a dangerous endotoxin produced by certain bacteria and can trigger harmful immune responses in humans. However, current methods for detecting LPS are slow and complicated. To address this issue, a research team has proposed a system based on a unique fluorescent chemosensor that can detect LPS within minutes, making it ideal for on-site testing in hospitals and pharmaceutical manufacturing facilities. The COVID-19 pandemic highlighted the need for faster pathogen and toxin screening methods. One such toxin is LPS, which is often referred to as “endotoxins.” This molecule is found in the outer membrane of certain bacteria and can be highly harmful, causing fever, inflammation, and even organ failure in severe cases. Surprisingly, despite its prevalence, there are very few effective methods to detect LPS. The current gold standard, the limulus amebocyte lysate (LAL) test, is a manual and time-consuming process that takes several hours and is costly. Other methods for LPS detection are also slow or cumbersome, leading to delays in decision-making in healthcare and pharmaceutical settings. Researchers at Sophia University (Tokyo, Japan; www.sophia.ac.jp) have pioneered a novel approach to rapidly detect LPS in liquid samples. Their new platform has the potential to revolutionize LPS screening. At the core of this LPS analysis system is a ratiometric fluorescent chemosensor called Zn-dpa-C2OPy. This compound was designed to selectively bind to LPS and exhibits unique fluorescent properties. When not bound to LPS, it forms small spherical vesicles that emit specific-wavelength light upon exposure to UV rays. However, in the presence of LPS, the chemosensor forms complex aggregates with the toxin in the solution. These chemo-

sensor-LPS aggregates emit light at a different wavelength when exposed to UV rays, with their presence further confirmed using spectrometric measurements. To enable high-throughput LPS detection, the researchers combined the chemosensor with a flow injection analysis (FIA) system and a custom dual-wavelength fluorophotometer. This system allows for the easy mixing of a liquid sample with the chemosensor, and the mixture is then analyzed by the fluorophotometer to measure fluorescence changes in response to LPS. By comparing fluorescence intensities, the LPS concentration in the sample can be estimated. One of the major advantages of this system is its speed, as it only takes one minute from sample collection to obtaining results, with the capacity to process 36 samples per hour, making it exceptionally rapid and efficient. Additionally, the chemosensor-based analysis system is highly sensitive and stable for quantifying LPS, with a detection limit of 11 pM

(picomolar), surpassing other reported methods for LPS detection. The system is also simple and animal-friendly, unlike conventional LPS detection methods that use animal resources and may harm them. This makes it an excellent candidate for practical and efficient point-of-care testing for LPS and bacterial contamination in water, clinical, or pharmaceutical samples. With further advancements in this field, the threat of endotoxins can be minimized, enhancing safety in hospitals and improving diagnostic procedures for bacterial diseases. “Based on this research, an online-endotoxin monitor will be developed and made available for use in real-life situations,” said Takeshi Hashimoto from Sophia University. “Such a monitor could be installed at pharmaceutical production sites, hospital bedsides, and intensive care units to continuously monitor endotoxin concentration in pharmaceutical products, such as water for injection, or the blood of infected patients.”

Shenzhen Dymind Biotechnology Co., Ltd Hematology

VISIT US AT

DM61 VET

LabMedica International November/2023

DH20

MF1280

LINKXPRESS COM

Coagulation

DH-800

LMI-11-23 125

POCT

CA1200

Veterinary

Immunology

DP-H10

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

PIPETTE CONTROLLER

AUTOMATED IMMUNOBLOT TESTING SYSTEM GRIFOLS DIAGNOSTIC

ANTI-CYCLIC CITRULLINATED PEPTIDE TEST

The Greiner Bio-One Sapphire MaxiPette pipette controller is lightweight and designed to fit comfortably in either hand. It features a self-inverted and ergonomic design for easy handling and offers variable speed control.

The HELIA automated system for immunoblot testing is designed for total immunoblot automation from the primary sample tube to result interpretation. It features a minimal footprint and integrated camera module.

The GPP-100 Anti-CCP Kit is intended for measurement of anti-cyclic citrullinated peptide (CCP) antibody, a diagnostic biomarker of rheumatoid arthritis (RA). The all-inone cartridge for single test can run on the GPP-100 analyzer.

LINKXPRESS COM

GREINER BIO-ONE

LMI-11-23 231

LMI-11-23 232

GOLDSITE DIAGNOSTICS

LMI-11-23 233

AI Model Predicts Brain Cancer Outcomes by Assessing Stained Images of Glioblastoma Tissue

lioblastoma, a swift and aggressive brain cancer, typically grants an average life expectancy of around one-year post-diagnosis. Treating it proves challenging due to substantial variations in each tumor's cellular composition among individuals. This diversity hampers effective strategies. Even after undergoing surgery,

For small and medium labs, @SINGUWAY is your answer. ≤30 minutes Singu20 Nucleic Acid Extractor

AccuRa-32 Real-Time PCR System (32 samples)

≤35 minutes Singu20 Nucleic Acid Extractor

AccuRa mini Real-Time PCR System (8-16 samples)

qPCR Detection Kits (PCR fluorescence method): Respiratory Diseases: COVID-19, fluA, fluB, AdV, TB and multiplex test Blood Diseases: HBV, HCV, HIV and multiplex test Sexually Transmitted Diseases: HPV, CT, NG, UU and multiplex test Viral Zoonotic Diseases: MPV Vector-borne Diseases: PF, ZIKV Genetic Diseases: MTHFR Animal Diseases: Swine/Avian/Aquatic Animal/Ruminant/Companion Animal Diseases

5-Part Hematology Analyzer

Hematology + CRP +SAA Joint Analyzer (Auto Sampling)

radiation, and chemotherapy, residual cancer cells remain. Almost all glioblastoma patients experience a relapse, with differing timelines. Predicting prognosis also presents difficulties, given the complex nature of understanding which cancerous cells drive each patient's glioblastoma. Now, scientists have created an algorithm designed to aid physicians in improving their understanding and targeting of complicated brain tumors. Scientists at Stanford Medicine (Stanford, CA, USA; www.med. stanford.edu) have developed an artificial intelligence (AI) model that evaluates stained images of glioblastoma tissue to predict tumor aggressiveness, ascertain the genetic constitution of tumor cells, and assess the presence of substantial cancerous cells post-surgery. The AI model holds the potential to help physicians identify patients exhibiting cellular traits indicative of more aggressive tumors, allowing for expedited follow-up. Typically, doctors and scientists utilize histology images, or pictures of dyed disease tissue, to identify tumor cells and formulate treatment strategies. While these images reveal the shape and location of cancer cells, they provide an incomplete tumor depiction. In recent times, an advanced technique known as spatial transcriptomics has emerged that reveals the cell location and genetic makeup of numerous cell types through specific molecules that identify genetic material in tumor tissue. The spatial transcriptomics data offers unprecedented insights into such tumors but the technique is expensive, with the data generation costing several thousand dollars per patient. Seeking a more economical approach, Stanford researchers turned to AI. They developed a model that utilizes spatial transcriptomics data to enhance basic histology images, creating a more detailed tumor map. The model was trained on spatial transcriptomics images and genetic data from over 20 glioblastoma patients. From these detailed images, the model was taught to make associations between cell types, cell interactions, and profiles with favorable or unfavorable cancer outcomes. For instance, it found that abnormal clustering of tumor cells resembling astrocytes, or neuron support cells, correlated with faster, more aggressive cancers. Studies show that such bunching of astrocytes prompts biological signaling, driving tumor growth. By discovering patterns like this telltale clumping, the model could aid drug developers in designing more targeted glioblastoma treatCont’d on page 27

LINKXPRESS COM

LMI-11-23 126

LabMedica International November/2023

To view this issue in interactive digital magazine format visit www.LabMedica.com

LabMedica International

AI Model Predicts Brain Cancer Outcomes by Assessing Stained Images of Glioblastoma Tissue Cont’d from page 26

ments. Spatial transcriptomics data from the same glioblastoma patients enabled the model to identify diverse tumor cells in corresponding histology images with an accuracy of 78% or higher. Essentially, it used cell shape to predict gene activation, providing insights into a cell's identity. The model could also be used by clinicians to gauge the success of tumor removal after surgery and how much still remains in the brain. For instance, the model revealed that tumor cells with genetic traces of oxygen deprivation are usually situated in the center of a patient’s tumor. Higher proportions of these cells corresponded to worse cancer outcomes. By illuminating the oxygen-deprived cells in histology-stained surgery samples, the model can assist surgeons in estimating residual cancer cells post-surgery and determining the appropriate time for post-surgical resumption of treatment. After being trained to identify the location of various cell types using basic images, the model was evaluated on a larger, separate data set of histology images from 410 patients. The model inferred cancer outcomes from these images, effectively identifying cell patterns correlating with cancer aggressiveness. The model holds the potential to help physicians identify patients with cell patterns signaling a more aggressive tumor and imminent threat of relapse or rapid growth. Although the researchers are optimistic about the model's predictive capacity, further training on more patients is necessary before its deployment to physicians. The team intends to refine the model to create even more detailed cellular maps of glioblastoma tumors. Currently, a proof-ofconcept version of their model, GBM360, is available for researchers to upload diagnostic images and predict glioblastoma patient outcomes. However, the model is still in the research phase, and its algorithmic outcomes should not yet guide patient care. The researchers hope that the algorithm could eventually predict outcomes for other conditions like breast or lung cancers.

Simple Genetic Test Identifies Patients Vulnerable to Severe Side Effect of MS Drugs

everal medications prescribed for conditions ranging from multiple sclerosis and blood cancers to rheumatoid arthritis have been associated with a rare but often deadly neurological disorder known as progressive multifocal leukoencephalopathy (PML). PML destroys the cells responsible for creating myelin, the protective substance surrounding nerve cells in the brain. It's triggered by a virus present in as many as 85% of adults but only becomes active when the immune system is significantly weakened. Now, a simple genetic test makes it possible to identify individuals at a tenfold higher risk of developing PML, allowing them to consider safer treatment alternatives. Researchers from Population Bio, Inc. (New York, NY, USA; www. populationbio.com) conducted the most extensive study so far to examine the relationship between medications that heighten PML risk and specific genetic predispositions. They analyzed data from the Food and Drug Administration Adverse Event Reporting System (FAERS) and identified 81 drugs, along with another 18 from the same drug class not reported to FAERS, that are linked to the development of PML. A majority of these drugs are used as immunosuppressant disease-modifying therapies. The researchers evaluated whether these medications mentioned the risk of PML on their labels, either as a Serious Adverse Event (SAE) or featuring a Boxed Warning, the FDA's most severe label caution. They noted that the majority of PML cases are associated with two drugs, natalizumab (used for MS) and rituximab (used for cancer and rheumatoid arthritis), Cont’d on page 28

LabMedica International November/2023

Image: A new algorithm could help better understand and target complicated brain tumors (Photo courtesy of Freepik)

Development and production of In Vitro Diagnostics

DISCOVER OUR SOLUTIONS AT OUR BOOTH #D16, HALL 3. TAKE PART TO OUR SPEECHES ABOUT: MOLECULAR DIAGNOSTICS FIT (Fecal Immunochemical Test) CHROMATOGRAPHY Scan the QR to see the program and book your seat. You can also contact us at marketing@sentinel.it

Sentinel CH. S.p.A Via Robert Koch, 2 20152 Milan Italy Phone: +39 02 36 21 71 Fax: +39 02 36 217 464 sentinel@sentinel.it www.sentineldiagnostics.com LINKXPRESS COM

LMI-11-23 127

WORLD’S CLINICAL DIAGNOSTICS MARKETPLACE

To receive prompt and free information on products, log on to www.linkXpress.com or scan the QR code on your mobile device

CYTOLOGY PROCESSOR

1-CHANNEL COAGULATION INSTRUMENT

SEMIAUTOMATIC URINE ANALYZER

CYTOfast Plus is a liquid-phase cytology processor of the CYTOfast system, designed for the processing of thin-layer cytological preparations from liquid-phase samples and based on patented Nephelometric Smart Technology (NST).

The HumaClot Junior is a compact 1-channel coagulation instrument that uses the latest LED technology with reference channel and features validated applications for HUMAN reagents preprogrammed.

The U-AQ Smart is a semiautomatic urine analyzer that automates the forwarding, reading and evaluating steps. The operator only must dip the strip into sample and place it on the strip loading while results are stored and printed.

LINKXPRESS COM

HOSPITEX DIAGNOSTICS

HUMAN GMBH

LMI-11-23 234

LMI-11-23 235

HUMASIS

LMI-11-23 236

Simple Genetic Test Identifies Patients Vulnerable to Severe Side Effect of MS Drugs

RS TO LY IBU PP TR TO A S I D ED IT INV

YOUR GLOBAL SOURCE FOR STERILIZATION ACCESSORIES THERMO RESISTANT GLOVES Up to 37 cm in length

STERILIZABLE INSTRUMENT & WORK-SURFACE MATS Thermo-Resistant (-60 °C to 300 °C) Fully Washable & Flexible Suitable for central sterilization services Sterilizable

TURBO WASHING MACHINES TRAYS

Heavy Silicone Cover & Transport Tablet

MICRO INSTRUMENT MAT

SILICON INSTRUMENT MAT

Front

WASHING TRAYS MAT

Front

Back

WASHING TRAYS MAT

Back

Front

NEW! SILICONE TABLET AND STEEL COVER NETS

Exchangable Net

STERILIZABLE WORK-SURFACE MATS Exchangable Nets

100% Silicone

Size: 2400 x 1200 mm (3 mm thick)

VICOTEX

S.A.

Place de la Gare 1 • 1009 Pully • Switzerland Tel: (41) 21-728-4286 • Fax: (41) 21-729-6741 E-Mail: contact@vicotex.com

www.vicolab.com LINKXPRESS COM

LMI-11-23 128

Cont’d from page 27

both of which carry a Boxed Warning. Surprisingly, they discovered that two commonly used blood cancer drugs, daratumumab and venetoclax, have no PML risk warning on their labels. The researchers found that recently-identified genetic variants in four specific genes (C8B, FCN2, LY9 and STXBP2) increased an individual's susceptibility to PML by tenfold if they are taking one of these high-risk medications. These genetic variants are critical players in immune functions and disorders that activate the JC virus, which is dormant in most people. If the JC virus becomes active in someone with a weakened immune system, it can lead to PML. A free genetic test is now available for patients contemplating the use of such medications. If they possess one of these genetic variants, alternative treatment options that do not carry a PML risk should be considered, according to the team. “The increased risk of drug-induced PML in patients testing positive is higher than already-known genetic associations that are used to guide treatments, like BRCA1/2 for breast cancer, yet many neurologists and oncologists may have limited awareness of how many drugs have been linked to PML,” said Peggy S. Eis, PhD, lead author of the study and chief technology officer at Population Bio, Inc. “There are no treatments to cure PML, so prevention is the best defense, including knowing your genetic risk. Even though the chance of developing PML is very low for some of these drugs, patients should still be screened given the ease and low cost of doing so relative to the avoidable potential consequences for those who do test positive. Clearly, warning labels on some of these drugs need to be updated and can now include a requirement for genetic testing before these drugs are prescribed.” LabMedica International November/2023

NEWS

Edited by Katherina Psarra, MSc, PhD IFCC members may send news to Email: enews@ifcc.org

Industry Leaders Call for Proposals for Investigator Initiated Studies from Lab Specialists Worldwide By: Jean-Sebastien Blanchet, Director Medical and Scientific Affairs, Beckman Coulter; Nadav Kaufman, Senior Director, Global Marketing, QuidelOrtho; Anne Skurup, Senior Medical Advisor, Radiometer Medical

What are Investigator Initiated Studies (IIS)? Investigator Initiated Studies (IIS) are defined as studies conceived and led independently by investigator(s). IIS are proposed and managed by external researchers who are not employed by a product manufacturer and may be supported and/or have associations/partnerships with one or more manufacturers. Some diagnostic manufacturers may be readily interested in supporting investigator-initiated studies as a valued way to expand the knowledge base supporting a specific product. Such independent evaluations may also support mandatory post market surveillance needs performed by manufacturers. When companies initiate clinical studies, internal teams define the study aims, protocols, statistical analysis plan, expected publication, and many other details. Clinical studies required for product registration as part of the IVDR regulation in Europe or FDA submission in the US are usually entirely managed by companies’ clinical and regulatory affairs departments, following strict execution processes and well-defined quality standards. IIS are different, as they are initiated from an unsolicited proposal by an independent investigator, who then maintains control of the study. As such, most supporting companies leave a large degree of freedom to investigator(s) for most aspects of the study, so long as minimum expectations are met to ensure high quality standards, good business practices and legal, ethical and regulatory compliance. Why propose an IIS? Investigators may propose IIS to manufacturers to address a wide variety of scientific objectives, including: • To evaluate analytical and/or clinical performance of an assay in specific patient populations, in the context of local standard of care or specific therapies, including real-world evidence. • To perform reference interval studies: either to confirm the manufacturer’s proposed ranges or to add ranges for specific patient populations. • To address the potential clinical impact of an intervention in preanalytical, analytical or post-analytical phases to improve laboratory workflow, time to first result and patient outcomes, leading to the demonstration of clinical utility and potentially to the development of institution’s policies. • To demonstrate the health economics benefits of an IVD assay in routine clinical practice. Steps to Propose an IIS: Companies typically evaluate IIS proposals through a formal review process, which often includes a scientific review, as well as compliance assessment. These reviews assess the scientific and clinical relevance of the proposal, robustness, as well as the appropriateness of the requested support. This review process can be lengthy, depending upon the various teams involved, and may take between two and twelve weeks to decide if and how support for the study is possible.

IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • E-mail: ifcc@ifcc.org • Web: www.ifcc.org Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi, Elisa Fossati, Sofia Giardina, Smeralda Skenderaj The views and positions expressed in the IFCC News section are those of the IFCC or the individual authors, and do not necessarily represent the views or positions of LabMedica magazine or its publishers.

LabMedica International November/2023

Anne Skurup Radiometer

Jean-Sebastien Blanchet Beckman Coulter

Nadav Kaufman QuidelOrtho

1. Identify the research question To propose an IIS, first identify an area of interest and determine what scientific question(s) you seek to answer. Innovative and novel studies are preferred by some companies, but studies which seek to confirm previous conclusions also have relevance, as they reinforce scientific understanding. 2. Design the protocol Once the research question is well defined, identify the appropriate study design to answer the question. Develop a detailed protocol describing the study. It is important to keep in mind that for IIS the protocol should be provided by the investigator. However, companies may offer suggestions to the protocol after an initial review to ensure the quality of the study. 3. Estimate the budget Based on the protocol, an assessment of the required support will be defined and requested from the sponsoring company(ies). The support may range from simply seeking no-cost reagents/consumables, to much broader support such as provision of an analyzer, on-site support and training, or technical resources. Companies may also provide financial support to fund statistical analysis, testing labor, and writing of results. An agreement on the study outcomes, timelines and the final publication of the data shall be reached as well between the investigator and the supporting company. Cont’d on page 31

NEWS

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

India’s Annual Conference Excels Amid Kerala’s Vibrant Scientific Hub

By Bernard Gouget, Chair C-MHBLM; Pradeep Dabla, Member C-MHBLM; Damien Gruson, ETD-EC Liaison; Sergio Bernardini, Chair ETD.

CBICON 2023, the 49th Annual Conference of the Association of Clinical Biochemists of India, took place in Kerala State on September 13-16, 2023, at the Al-Saj International Convention Centre in Thiruvananthapuram, the state capital. The state, situated in the southwest corner of India, constitutes a narrow strip of land with its Western coast bordering the Arabian Sea. Thiruvananthapuram, formerly known as Trivandrum until 1991, is a distinguished center for academia and research, boasting numerous universities and research institutions. In this context, it was not surprising that the focal theme of the congress was “Laboratory Medicine Path Ahead: Amalgamating Technology and Humanity.” Photo: Speaker Group at the Congress, including the IFCC-C MHBLM The pre-conferences were thoughtfully designed to address team (Left to Right): Damien Gruson (BE), Bernard Gouget (FR), Seema the pressing needs of our time. The workshops reflect our colBhargava (IN), Helen Martin (AU), Tony Badrick (AU), Pradeep Dabla (IN) lective commitment to fostering a holistic perspective on Laboratory Medicine. They encompassed a wide range of topics, process and the collaboration between Lab Medicine and including the clinical applications of proteomics, genomics in emergency medicine to ensure quality testing. IFCC had the infectious diseases. honor of organizing several sessions. The first was organized The participants had the privilege of benefiting from the by the IFCC Committee on Clinical Laboratory Management presence of an impressive panel of expert speakers. The (IFCC C-CLM) with Praveen Sharma as the chair. Shruti Gupta spectrum of information was very rich, including plenary emphasized that professional best practices are a managerial sessions, scientific sessions, and roundtable discussions. At responsibility. Prasenjit Mitra highlighted the leadership role ACBICON congresses, it is customary to of medical biologists, while Sedef Yenice have the privilege of listening to several discussed the use of data analytics in clinbrilliant plenary lectures at the beginning ical laboratories Seema Bhargava chaired of each day. The K.L. Gupta Memorial the IFCC-C-EBLM session on the value and Oration was on “Recommendations and evidence of laboratory testing in diabetes approaches in cancer” by Alpana Sharma mellitus. from AIIMS Delhi. The Dr. K.P. Sinha OraThe IFCC-C MHBLM team (see photo) tion, titled “Counting on Patients, One and took the audience on a journey into the exAll,” was presented by Tony Badrick, APciting world of “AI Generative Intelligence FCB President. The Taranath Shetty Mefor the Better! “Artificial Intelligence (AI) has morial Oration focused on “Two Decades tremendous potential to advance clinical and of Raman Spectroscopy”. The Awadhesh laboratory practices, revolutionizing patient Memorial Oration was centered around care and opening up a world of incredible “Oral Cancer” and discussed by Shyam promise. Sergio Bernardini explored the role Chauhan. The Praven Sharma Oration was of AI and machine learning in Laboratory presented by Poornima Manjkekar in “DiMedicine and digital health, examining both abetes 2”. “Biomarkers and inflammatory the promise, pitfalls and potential challenges skin diseases” was the topic of the Dr. G. P. of their application across the healthcare Talwar Oration delivered by Medha Rajapcontinuum. pa. Dr. Seema Bhargava spoke brilliantly at Photo: Prof Dr Kannan Vaidyanathan, According to Pradeep Dabla, the increasACBICON 2023 organizing secretary the Dr. T.N. Patabhiraman Oration on “The ing reliance on methods of artificial intelliNobel laureates of biochemistry and the ‘not so Nobel’.” gence to guide patient care is not only transforming medicine The four-day event with the preconference workshops but will also transform the ways in which the specialists in Lab brought together, according to the “Veda Exotic Holidays” Medicine will be trained. Future healthcare professionals will team represented by Shiyas S.T., Jijin Joythi Babu, and Raj need to understand fundamental principles of data science and Naorayanan, nearly 1,000 participants. It was impossible to be capable to apply them to critically evaluate the emerging attend all the conferences. Among the topics covered were literature on AI in medicine and to do research in this emerging sessions on quality management, molecular diagnostics, field. hypercholesterolemia, inborn metabolic disorders, biomarkThe entire high-tech planet is in upheaval, three decades afers, etc.The third day of the congress was dedicated to oral ter the advent of the web, humanity is preparing to experience presentations by students. The exhibition halls with major IVD a new revolution whose scale promises to be gigantic, undercompanies were also the venue for poster sessions, which lined Bernard Gouget. However, unlike the Internet, which took are always enriching moments for fostering exchanges among time to establish itself and manifest its full effects, generative young professionals in medical biology. AI instantly reveals its potential. By providing free and open Helen Martin, APFCB traveling lecturer, gave us energy by access to Chat GPT interfaces for text generation and Dall-E2 presenting the benefits and requirements of vitamin D for opti- for image generation, the company Open AI (USA) has posimal health. The ACBM India section discussed the total testing Cont’d on page 32 LabMedica International November/2023

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

NEWS

IN MEMORIAM

Global IFCC Community Mourns Loss of Trailblazing Leader and Past President Jocelyn Hicks

by Graham Beastall, IFCC Past President

ocelyn Hicks died on 7th October 2023 at the age of 86 after a period of failing health. Jocelyn had a long and distinguished career in laboratory medicine. She was IFCC’s first female President and was instrumental in creating the African Federation of Clinical Chemistry. Jocelyn was born in Leamington Spa in England (Shakespeare country) and she retained her classical English accent throughout her life. After completing her BSc and MSc in London she moved to Washington DC in the USA where she qualified as a clinical chemist and was based for the rest of her life. Jocelyn developed an interest in paediatric clinical chemistry and quickly became established as an international expert on metabolic screening, reference values and the organisation and management of paediatric laboratories. She was the Professor of Pediatrics and Pathology at the George Washington University Medical Center. She published extensively and was an invited guest speaker at many national and international conferences. Jocelyn held numerous roles within the Association of Diagnostics and Laboratory Medicine (ADLM; formerly AACC). Starting at local level she soon became involved in publications at national level, before joining the Board of Directors from 1978 to 1980. She served as ADLM President in 1982; received The ADLM Outstanding Contributions Through Service to the Profession of Clinical Chemistry Award in 1984; and the ADLM Outstanding Contributions to Clinical Chemistry Award in 1993. She was a prominent champion and ambassador for our profession in the USA and was well respected by colleagues across the medical spectrum. Jocelyn became active in IFCC as

Chair of the Publications Division. She was responsible, with others for initiating the Journal of the IFCC. She joined the Executive Board as Treasurer and helped to strengthen IFCC finances while improving governance and accountability. During this period Jocelyn appreciated the immense contribution made to IFCC by the Office team in Milan and she always made time to encourage and develop her friendship with ‘the IFCC ladies’.

Jocelyn served as IFCC President from 2006 to 2008. She was immensely proud to be the first IFCC woman President and she became an inspiration for women in laboratory medicine across the world. She received numerous honours from IFCC Member societies and developed friendships that continued until her passing. Jocelyn also had a passion for helping developing countries to improve the quality, delivery, and impact of laboratory medicine. She invested a great deal of personal energy and time in Africa and the creation of the African Region of IFCC may be seen as a high point in her distin-

guished career. During her Presidency Jocelyn helped to create an international consensus on the role and measurement of HbA1c in the monitoring of diabetes, which further enhanced the role of IFCC in the world of medicine. She raised funds to introduce two series of IFCC specialised conferences that focussed on the central role of laboratory medicine in clinical medicine. From 2009 until 2014 Jocelyn served as Past President of IFCC. Six years as a Past President was a huge commitment and she was the last to serve for this period as the IFCC rules were changed to ensure that no-one could serve as President (and therefore Past President) for more than three years. Despite her ‘six-year sentence’ Jocelyn was an ever present at IFCC Executive Board meetings providing wisdom, positivity, and harmony to her younger, less experienced colleagues. One highlight was when Jocelyn hosted the Board to a gourmet meal at her home in Washington, which she had prepared for us with her customary attention to detail. In 2017 Jocelyn was awarded the IFCC-Wishinsky Award for Distinguished International Service. She treasured this award above all the others she received because ‘international service’ is a fitting tribute to describe her stellar contribution to our profession. Jocelyn displayed all the key characteristics of leadership. She was clear thinking, determined and extremely hard working. She was also warm-hearted, considerate, supportive of others, and great company. Jocelyn will be missed, and then remembered fondly, by hundreds of international friends. The world of laboratory medicine was improved and inspired by Jocelyn Hicks.

Industry Leaders Call for Proposals for Investigator Initiated Studies from Lab Specialists Worldwide

Cont’d from page 29

4. Establish the contract The company will conduct an internal review of the proposal to ensure scientific quality, but also to validate that the company support matches a fair market value, in compliance with legislations. Following a positive internal review, a contract will be established between the company and the investigator institution. The study can

LabMedica International November/2023

only begin after approved contract(s) are in place. Some companies may choose to follow up on study progress on regular basis, and provide financial support based on milestones. How to contact the company? To propose an investigator-initiated study, simply directly contact the target company and/or companies via their web

sites for scientific and medical affairs support or through your local company contact. Note: This article was developed in support and with endorsement from the IFCC TF-CM. It is not however all encompassing with general trends and recommendations and is not necessarily representative of the positions of the companies employing the authors.

NEWS

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

Empowering Women to Eliminate Cervical Cancer

Program ROSE: Removing Obstacles to Cervical ScrEening

ervical cancer is a devastating disease that affects women from all over the world. It also happens to be almost entirely preventable through vaccinations, proactive screening, and early intervention. A pivotal requirement to enable improvement is the need for sustained and culturally sensitive screening and monitoring programs. Typically, screening for cervical cancer is done through Pap Smear, with subsequent analysis of collected cells for cellular changes indicative of cancer. Pap smears can be often be uncomfortable, painful and/or inconvenient, such that many women do not receive the optimal cadence for screening. In Malaysia, this is no different, where only 1 in 4 women receive regular Pap Smears, with significant delay in results and linkage to care. Given that 99% of cervical cancers are caused by high-risk Human Papillomavirus (HPV), an innovative team of women created Program ROSE (Removing Obstacles to cervical ScrEening), whereby they have shifted the standard of care for cervical cancer screening to a self-swab method for HPV screening. This swab methodology not only identifies high-risk HPV strains, but empowers women in a culturally sensitive way, while requiring less frequent follow-up, with improved diagnostic accuracy. By combining self-swab collection with digital follow-up technology, Program ROSE has been able to provide improved access to high quality, while preserving the privacy and dignity of these women. Between 2018 and Feb 2020, >22,000 women have been screening through Program ROSE. Of those screened, 5.6% have HPV results requiring follow-up, with 91%

Photo: From left to right: Yit Lee Choo, Mun Li Yam, Marion Saville, Yin Ling Woo, Adeeba Kamarulzaman

of those women being linked to care. Importantly, 4 cases of previously unidentified, early stage cancers and 194 women with precancers were identified and linked to the appropriate care. The positive impact that Program ROSE continues to have on the health and wellness of Malaysian women will be felt for generations to come. For their efforts and outcomes, Program ROSE has been awarded the Top Global Honor of 2022 UNIVANTS of Healthcare Excellence Awards Winning Team. Congratulations to Yin Ling Woo, Founding Trustee and Medical Technical Advisor, ROSE Foundation Marion Saville, Professor of Laboratory Medicine and Trustee for the ROSE Foundation, Yit Lee Choo, CEO, ROSE Foundation, Adeeba Kamarulzaman, Chair, ROSE Foundation, Mun Li Yam, Operations Director, ROSE Foundation. To learn more about program ROSE and other winners please visit www.UnivantsHCE.com

India’s Annual Conference Excels Amid Kerala’s Vibrant Scientific Hub Cont’d from page 30

tioned itself with the most powerful testing ground. In just a few weeks, millions of people were able to play with the technology and test its capabilities and limits. Although the technology is still far from being stable and completely reliable, the beginnings are more than promising. Damien Gruson stated that in the rapidly evolving digital age, the metaverse, has emerged as a parallel dimension with immense potential to revolutionize various aspects of society, including laboratory medicine and patient care. By seamlessly integrating the natural and virtual worlds, the metaverse presents unparalleled opportunities for value creation and enhanced experiences. The convergence and integration of technologies within the metaverse are set to reimagine Laboratory Medicine services. From science to South Indian cuisine, from the sophisticated art scene with Kathakali dances to architectural treasures and historical sites such as the Shree Padmanabhaswamy temple, a famous Hindu temple dedicated to Maha Vishnu, there was much to discover in the capital of Kerala. Like Reverend Father Sijo Pandapallil, Senate Member of the Kerala University of Health Sciences and Manager at BCMCH, we would like to express our gratitude to all the professionals and volunteers who worked tirelessly to make this event a reality. The congress was an excellent opportunity to demonstrate that it is both possible and desirable to work together to improve healthcare and humanity. Note: The above is an abbreviated version of the subject review. For a full version please refer to the November issue of IFCC eNews at www.ifcc.org. LabMedica International November/2023

To view this issue in interactive digital magazine format visit www.LabMedica.com

Industry News

Fujirebio and Sysmex to Expand Alliance in Immunoassays

ujirebio Holdings (Tokyo, Japan; www.fujirebio.com) and Sysmex Corporation (Kobe, Japan; www. sysmex.co.jp) have entered into an agreement to expand their existing partnership across various areas, such as research, manufacturing, clinical development, and sales and marketing, in the field of immunoassay tests. Sysmex has been a key player in the field of in vitro diagnostics for over half a century, establishing both a solid technological base and an expansive global network. The company is keen to accelerate its presence in the immunochemistry sector, especially in the U.S. and European

Blood Culture Test Market Driven by Demand for Rapid Diagnostics

markets. Sysmex has been actively working on introducing unique, value-added tests, including the development of reagents that can detect the buildup of amyloid beta (Aβ) in the brain from blood samples, a key factor in Alzheimer’s disease, in both Japanese and U.S. laboratory developed test (LDT) markets. Fujirebio, on the other hand, boasts a comprehensive portfolio of reagent raw materials due to its long history in the immuno-

assay field. Lately, the company has not only been focused on developing its own products but has also been strengthening its Contract Development and Manufacturing Organization (CDMO) strategy to promote the global roll-out of specialized tests. Since 2020, Fujirebio has been collaborating with Sysmex by creating specialized reagents for Sysmex’s Automated Immunoassay System, known as HISCL-Series, through its subsidiary companies. The companies plan to identify specific areas where they can collaborate more deeply—like research, manufacturing, clinical trials, and sales strategies—with the goal of moving to the implementation stage by the end of March 2024. Fujirebio and Sysmex are committed to offering high-value tests to their global customer base as early as possible, driven by the strengthening of their partnership in immunoassay.

he global blood culture tests market is anticipated to grow at an 8% CAGR, rising from USD 5.2 billion in 2023 to USD 7.6 billion by 2028. The key factors fueling this market growth include the surging demand for rapid diagnostics, rising sepsis cases and their associated treatment costs, widespread infectious diseases, an aging population, and increasing incidents of bloodstream infections. However, hurdles such as the high cost of automation and a dearth of skilled laboratory personnel could limit market growth. These are the recent findings of the global market research firm MarketsandMarkets (Northbrook, IL, USA; www.marketsandmarkets.com) In the foreseeable future, the blood culture tests market is strongly positioned for notable advancements on the back of cutting-edge technologies and pioneering research. The increased focus on personalized medicine and rapid diagnostic solutions will lead to a transformative shift in blood culture tests towards faster, more accurate, and comprehensive detection of infectious agents. There will be a surge in the prevalence of microfluidic-based platforms, enabling higher-throughput analysis and quicker processing times—critical for the early detection and efficient management of infections. Additionally, advancements in machine learning algorithms and artificial intelligence will expedite the real-time analysis of vast datasets, enhancing the identification of pathogens and the profiling of antibiotic resistance. Moreover, the integration of point-of-care blood culture devices with telemedicine and cloud-based platforms will improve accessibility and facilitate smooth communication between medical professionals and patients. As the growth of the blood culture tests market surges, these advancements will play a key role in revolutionizing the diagnosis and treatment of infectious diseases, ultimately resulting in improved patient outcomes and global healthcare systems.

LabMedica International November/2023

250+ EDUCATIONAL OPPORTUNITIES

VISIT US AT

300+ EXPERT SPEAKERS 900+ EXHIBITORS

2023

Hall 3 • C16-6

EXPO ONLY REGISTRATION AND CALL FOR ABSTRACTS OPEN NOVEMBER 2023

Learn more at meeting.myadlm.org

JAMIE ACERO, BS, MHA, CPP

Events Calendar For a free listing of your event or a paid advertisement contact: LabMedica International Calendar E-mail: info@globetech.net

2023

2024

NOVEMBER 53rd Mexican National Congress of Clinical Pathology. Nov 1-4; Aguascalientes, Mexico; fempac.org.mx ASHG 2023 – Annual Meeting of the American Society of Human Genetics. Nov 1-5; Washington, DC, USA; ashg.org 44th Annual Meeting of the American College of Toxicology (ACT). Nov 12-15; Orlando, FL, USA; actox. org MEDICA 2023. Nov 13-16; Dusseldorf, Germany; medica-tradefair.com AMP 2023 – Annual Meeting & Expo of the Association for Molecular Pathology. Nov 14-18; Salt Lake City, UT, USA; amp.org 71st Annual Scientific Meeting of the American Society of Cytopathology (ASC). Nov 15-19; Austin, TX, USA; cytopathology.org 2023 Annual RBSLM Meeting - Royal Belgian Society of Laboratory Medicine. Nov 17; Brussels, Belgium; rbslm.be JIB 2023 – Journées de l’innovation en biologie. Nov 17-18; Paris, France; jib-innovation.com 34th Regional Congress of the International Society of Blood Transfusion (ISBT). Nov 18-21; Cape Town, South Africa; isbtweb.org 4th Congress of the Chilean Medical Society of Clinical Laboratory. Nov 23-24; Santiago, Chile; Web: smlc.cl IUIS 2023 – International Union of Immunological Societies. Nov 27 - Dec 2; Cape Town, South Africa; iuis2023.org

DECEMBER

ASI 2023 – 51st Annual Scientific Meeting of the Australian and New Zealand Society for Immunology. Dec 4-8; Auckland, New Zealand; asi2023.org 65th Annual Meeting & Exposition of the American Society of Hematology (ASH). Dec 9-12; San Diego, CA, USA; hematology.org ASLM2023 - 6th Biennial Conference of the African

LabMedica International Inq.No.

Advertiser

Society for Laboratory Medicine. Dec 12-15; Cape Town, South Africa; aslm2023.org AMBICON 2023 – 30th National Conference of the Association of Medical Biochemists of India (AMBI). Dec 13-16; Navi Mumbai, India; ambi.co.in

FEBRUARY SLAS 2024 – International Conference & Exhibition of the Society of Laboratory Automation and Screening. Feb 3-7; Boston, MA, USA; slas.org Medlab Middle East 2024. Feb 5-8; Dubai, UAE; medlabme.com Labquality Days 2024 – International Congress on Quality in Laboratory Medicine. Feb 8-9; Helsinki, Finland; labqualitydays.fi 3rd International Congress of Laboratory Diagnosis 2024. Feb 15-18; Virtual; ldcongress.com Pittcon 2024. Feb 24-28; San Diego, CA, USA; pittcon. org

MARCH

ICE 2024 – 21st International Congress of Endocrinology. Mar 1-3; Dubai, UAE; isendo.org China Lab 2024. Mar 5-7; Guangzhou, China; chinalabexpo.com MASCL 2024 – Congress of the Association for Mass Spectrometry & Advances in Clinical Lab. Mar 17-22; Monterey, CA, USA; msacl.org USCAP 113th Annual Meeting – United States & Canadian Academy of Pathology. Mar 23-28; Baltimore, MD, USA; uscap.org

APRIL

Analytica 2024. Apr 9-12; Munich, Germany; analytica.de India Lab Expo & Analytica Anacon India. Apr 15-17; Mumbai, India; analyticaindia.com Korea Lab 2024. Apr 23-26; Seoul, Korea; korealab. org ExpoMED Eurasia 2024. Apr 25-27; Istanbul, Turkey; expomedistanbul.com ECCMID 2024 – 34th European Congress of Clinical Microbiology and Infectious Diseases. Apr 27-30; Barcelona, Spain; eccmid.org

Advertising Index Page

Inq.No.

Advertiser

Vol. 40 No. 7 11/2023 Page

–

ADLM......................................... 33

108

Mast . . . . . . . . . . . . . . . . . . . . . . 8

105

Agappe......................................... 5

115

Nova Biomedcal. . . . . . . . . . . . 15

116

Awareness Technology Inc........ 16

102

Quantimetrix. . . . . . . . . . . . . . . . 2

124

Awareness Technology Inc........ 24

111

Randox. . . . . . . . . . . . . . . . . . . 11

120

B&E Bio-technology................... 20

121

Sekisui. . . . . . . . . . . . . . . . . . . . 21

107

DiaSys Diagnostic Systems......... 7

127

Sentinel Diagnostics. . . . . . . . . 27

110

DxGen........................................ 10

126

Singuway. . . . . . . . . . . . . . . . . . 26

125

Dymind....................................... 25

103

Snibe. . . . . . . . . . . . . . . . . . . . . . 3

118

Globe Scientific.......................... 18

123

The Lee Company . . . . . . . . . . 23

–

IFCC WorldLab 2024................. 29

113

Urit . . . . . . . . . . . . . . . . . . . . . . 13

–

LabMedica EXPO..................... 35

119

Vedalab. . . . . . . . . . . . . . . . . . . 19

122

Lifereal....................................... 22

109

Vircell . . . . . . . . . . . . . . . . . . . . . 9

114

Lifotronic. . . . . . . . . . . . . . . . . . 14

117

Werfen. . . . . . . . . . . . . . . . . . . . 17

112

Lumiquick . . . . . . . . . . . . . . . . . 12

136

Werfen. . . . . . . . . . . . . . . . . . . . 36

Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.

MAY Immunology 2024 – Annual Meeting of the American Association of Immunologists (AAI). May 3-7; Chicago, IL, USA; immunology2024.aai.org AACE Annual Meeting 2024 – American Association of Clinical Endocrinology. May 9-11; New Orleans, LA USA; pro.aace.com ECE 2024 – 26th Annual Congress of the European Society of Endocrinology. May 11-14; Stockholm, Sweden; ese-hormones.org ASRI 2024 – 43rd Metting of the American Society for Reproductive Immunology. May 18-22; Houston, TX, USA; theasri.org Hospitalar 2024. May 21-24; Sao Paulo, Brazil; hospitalar.com 107th Annual Meeting of the German Society for Pathology. May 23-25; Munich, Germany; pathologie-dgp.de IFCC WorldLab 2024 – 26th International Congress of Clinical Chemistry and Laboratory Medicine. May 2630; Dubai, UAE; dubai2024.org SLAS Europe 2024 Conference and Exhibition - Society of Laboratory Automation and Screening. May 27-29; Barcelona, Spain; slas.org ISLH 2024 – International Society for Laboratory Hematology. May 30 - Jun 1; Nantes, France; islh.org EAACI 2024 – Annual Congress of the European Academy of Allergy & Clinical Immunology. May 31 Jun 3; Valencia, Spain; eaaci.org

JUNE

ESHG 2024 – European Human Genetics Conference. Jun 1-4; Berlin, Germany; eshg.org UKMedLab24 – National Meeting of the Association for Clinical Biochemistry and Laboratory Medicine. Jun 10-12; Brighton, UK; acb.org.uk 9th International Symposium on Critical Care Testing and Blood Gases. Jun 13-14; Saint-Malo, France; criticalcaretesting-saintmalo2024.eu ASM Microbe 2024 – American Society for Microbiology. Jun 13-17; Atlanta, GA, USA; asm.org 49th CBAC – Congress of the Brazilian Society of Clinical Analysis. Jun 16-19; Natal, Brazil; sbac.org.br 2024 CSCC Annual Conference – Canadian Society of Clinical Chemists. Jun 17-20; Mont Sainte-Anne, QC, Canada; cscc-sccc.ca

LINKXPRESS COM

R E A D E R

S E R V I C E

P O R T A L

Renew/Start Your Free Subscription Access Instant Online Product Information

Every advertisement or product item contains a LinkXpress number as below: LINKXPRESS COM

LMI-11-23 999

LinkXpress codes of 1 Identify interest as you read magazine on LinkXpress.com 2 Click to reach reader service portal code(s) of interest on 3 Mark LinkXpress inquiry matrix

ATTENTION: IF YOUR APPLICATION IS NOT RECEIVED AT LEAST ONCE EVERY 12 MONTHS YOUR FREE SUBSCRIPTION MAY BE AUTOMATICALLY DISCONTINUED

Events Calendar FOCIS 2024 – Annual Meeting of the Federation of Clinical Immunology Societies. Jun 18-21; San Francisco, CA, USA; focisnet.org FIME 2024 – Florida International Medical Expo. Jun 19-21; Miami, FL, USA; fimeshow.com ISTH 2024 Congress – International Society on Thrombosis and Haemostasis. Jun 22-26, Bangkok, Thailand; isth2024.org ECC 2024 – 45th European Congress of Cytology. Jun 23-26; Leipzig, Germany; cytology2024.eu 38th International Congress of the International Society of Blood Transfusion (ISBT). Jun 23-27; Barcelona, Spain; isbtweb.org AMP Europe 2024. Jun 24-26; Madrid, Spain; amp.org ASV 2024 – 43rd Annual Meeting of the American Society of Virology. Jun 24-28; Columbus, OH, USA; asv.org FEBS 2024 – 48th Congress of the Federation of European Biochemical Societies. Jun 29 Jul 3; Milan, Italy; febs.org ECB 2024 – European Congress on Biotechnology. Jun 30 - Jul 3; Maastricht, The Netherlands; ecb2024.com

JULY

ESHRE 2024 – 40th Annual Meeting of the European Society of Human Reproduction and Embryology. Jul 7-10; Amsterdam, Netherlands; eshre.eu MedLab Asia 2024. Jul 10-12; Bangkok, Thailand; medlabasia. com 2024 ADLM Annual Scientific Meeting & Clinical Lab Expo. Jul 28 - Aug 1; Chicago, IL, USA; meeting.aacc.org

AUGUST

COLABIOCLI 2024 - 26th Latin American Congress of Clinical Biochemistry. Aug 28-31; Cartagena, Colombia; colabiocli.com 64th Annual Academic Assembly of the Japan Society of Clinical Chemistry (JSCC). Aug 30 - Sep 1; Utsunomiya, Japan; jscc-jp.gr.jp

SEPTEMBER

ASCP 2024 – Annual Meeting of the American Society for Clinical Pathology. Sep 4-6; Chicago, IL, USA; ascp.org ECP 2024 – 35th Congress of the European Society of Pathology. Sep 7-11; Florence, Italy; esp-congress.org EUROTOX 2024 – 58th Congress of the European Societies of Toxicology. Sep 8-11; Copenhagen, Denmark; eurotox2024. com Thailand LAB International 2024. Sep 11-13; Bangkok, Thailand; thailandlab.com ESVC 2024 – Annual Meeting for the European Society for Clinical Virology. Sep 17-21; Frankfurt, Germany; escv.eu DKLM 2024 – Annual Congress of the German Society for Clinical Medicine and Laboratory Medicine (DGKL). Sep 25-27; Bremen, Germany; dgkl.de

LabMedica International November/2023

India Lab Expo & Analytica Anacon India. Sep 26-28; Hyderabad, India; analyticaindia.com

OCTOBER

56th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC). Oct 8-10; Bologna, Italy; sibioc.it CAP24 – Annual Meeting of the College of American Pathologists. Oct 19-22; Las Vegas, NV, USA; cap.org ASHI 2024 – 50th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Oct 21-24; Anaheim, CA, USA; ashi-hla.org MedLab Africa 2024. Oct 22-24; Johannesburg, South

Africa; africahealthexhibition.com APFCB Congress 2024 – Asia Pacific Federation for Clinical Biochemistry and Laboratory Medicine. Oct 31 - Nov 3; Sydney, Australia; apfcbcongress2024.org

NOVEMBER

MEDICA 2024. Nov; Dusseldorf, Germany; medica-tradefair.com Analytica China 2024. Nov 18-20; Shanghai, China; analyticachina.com.cn AMP 2024 – Annual Meeting & Expo of the Association for Molecular Pathology. Nov 21-23; Vancouver, BC, Canada; amp.org

Hemostasis automation that works on so many levels. HemoCell delivers workcell efficiency, quality and standardization for Hemostasis labs. Featuring ACL TOP® 750 LAS and HemoHub™ Intelligent Data Manager, it’s the only workcell to combine the leading Hemostasis testing system with specialized lab automation. And, because it can be customized to your lab’s specific needs, HemoCell lets you design the automation layout that’s right for you.

Make your lab a HemoCell lab.

For more information, contact your local Werfen representative. werfen.com

LINKXPRESS COM

LMI-11-23 136

LINKXPRESS COM

LMI-4-23 132

ACL, ACL TOP, HemoCell and HemoHub are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. The Werfen logo is a trademark of Werfen and may be registered in the Patent and Trademark Offices of jurisdictions throughout the world. ©2021 Instrumentation Laboratory. All rights reserved.