Cancergenetics dos 06 17 16 by Cancer Genetics, Inc.

EMPOWERING PERSONALIZED CANCER TREATMENT

DIRECTORY OF SERVICES

Cancer Genetics is focused on empowering personalized cancer treatment through the development of innovative products and services that drive patient value across the diagnosis, management, and treatment of cancer. RUTHERFORD, NJ

LOS ANGELES, CA

SHANGHAI, CHINA

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CONTACT Web: contact@cgix.com Email: www.cancergenetics.com

CONTENTS About Cancer Genetics

Billing

Clinical Services

Billing Policies

Biopharma Services

CPT Codes

Innovation Services 10

Licensure

Quality Control Program

Licenses and Credentials

Compliance Statement

Reporting

CGI Reports

SummationTM Reports

Requisition Forms

Ordering Requisition Forms

Partnerships and Collaborations 12 Oncospire Genomics 14 Our Clinical Team 16 Our Biopharma Team 20 Our Locations 22

Clinical Testing Services 23 Overview 25 Our Unique Tests 26 Completeâ&#x201E;˘ Testing 36 Technical-Only Testing 39 Clinical Test Menu 40

Specimen Collection 47 Sending Specimens 48 Specimen Collection 49 Specimen Requirements 50

ABOUT OUR COMPANY 5

CLINICAL SERVICES

Empowering Personalized Cancer Treatment By identifying the unique genetic makeup of each patient and their cancer, biomarker-based oncology testing is helping to revolutionize cancer treatment. Testing patients for specific biomarkers can provide insight into diagnosis, prognosis, and a patientâ&#x20AC;&#x2122;s likelihood of responding to certain treatments. With this information, we can help predict the probable outcome of an individualâ&#x20AC;&#x2122;s disease, and enable clinicians to personalize the clinical management for each individual patient. Through our Clinical Services, we provide hospitals and cancer centers with state-of-the-art genomic testing. Our reference laboratory utilizes both our proprietary tests, as well as more common tests, to offer comprehensive genomic testing for a number of cancers. To ensure proper specimen management and quick turnaround time, services are all performed in our CLIAcertified and CAP-accredited clinical laboratories. We continuously expand our test menu as new technologies and biomarkers of clinical utility are developed. Through our range of unique and common cancer testing services, we are empowering personalized cancer treatment.

BIOPHARMA SERVICES

A Partner from Bench to Bedside While tremendous advances have been made in the way we manage and treat cancers, there remains significant need for better, more targeted therapies and drugs. Oncology drugs have the potential to be among the most personalized of therapeutics, yet oncology trials have some of the poorest approval rates. In an effort to improve the outcome of these trials, and more rapidly advance targeted therapeutics, biotechnology and pharmaceutical communities are increasingly moving towards biomarker-based therapeutics. For pharmaceutical companies engaged in oncology-focused clinical trials, CGIâ&#x20AC;&#x2122;s proprietary and comprehensive oncology testing services, pharmacogenomic testing, and clinical trials support services can help better select candidate populations and reduce adverse drug reactions. CGI has deep knowledge and experience in designing, developing, and validating assays with biomarkers of clinical relevance for cancer diagnosis, prognosis and theranosis. Our expansive offerings in pharmacogenomic testing help deliver safer, more effective drugs to market more efficiently.

CGIâ&#x20AC;&#x2122;s clinical team is backed by our strong R&D background. With an in-depth understanding of complex cancer states, our R&D team has developed a number of innovative, proprietary tests. We leverage this knowledge and experience in oncology-based testing to provide solutions that lead to effective patient stratification, increased responder population, and endpoints validation and optimization. The size of our company enables us to respond quickly to the needs of clients and provide them with highquality outcomes for clinical trials. Our laboratories are CLIA-certified and CAP-accredited to ensure the services we provide to clients are accurate and reliable. With locations in the US, India, and China, CGI is a global partner of choice for companies engaged in oncology-based clinical trials.

Greater Insights Require Integrated Information from Multiple Technologies

Our Biopharma Highlights Include:

Immuno-Oncology Companion Diagnostics Partnerships Immunohistochemistry (IHC) to detect critical biomarkers such as PD-L1 [fda-approved]

Phase I to Phase III Global Solid Tumor & Heme Malignancy Clinical Trials from 24 Countries NIH Alchemist Trial Support EGFR mutations (Sanger Sequencing), ALK rearrangements (FISH), PD-L1 (IHC)

Contracts with 8 of 10 Top Biopharma Companies

360+ Number of Clinical Assays

INNOVATION SERVICES

Inspired by Patients, Driven to Discovery Our discovery services are central to our mission and ability to deliver on the promise of personalized medicine. CGIâ&#x20AC;&#x2122;s world-class R&D team boasts expertise across a number of cancer categories and includes some of the leading research scientists from the areas of hematological, urogenital, and HPV-associated cancers. We have established strong research collaborations with major cancer centers and academic research organizations including Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute. Our innovative and collaborative genomics research program puts CGI at the forefront of cancer diagnostics.

CGI has developed a number of unique, proprietary products across a number of technology platforms. These tests are being used in the clinical setting to inform cancer treatment, and by biopharma and biotech customers to improve clinical trial success. Products being delivered at CGI are poised to transform cancer patient management, increase treatment efficacy, and reduce healthcare costs. In addition to our unique diagnostic and prognostic tests for the clinical setting, CGI provides custom assay development for pharmacogenomic testing.

Patents and Applications CGI has a strong and growing portfolio in molecularfocused patents for the diagnosis, prognosis, and risk stratification of difficult-to-diagnose cancers. Our patents are based on unique algorithms that take into account multiple chromosomal regions associated with particular disease outcomes or treatment decision.

CGI’s FISH-probes Methods of Analyzing Chromosomal Translocations Using Fluorescence In Situ Hybridization (FISH). • US Patent No. 7,585,964. Filed May 15, 2002 • US Patent No. 7,964,345. Filed April 5, 2005. • Canadian Patent No. 2,447,320. Pub. Nov. 21, 2002.

FHACT® CGI’s FISH-based HPV-Associated Cancer Test Methods and Tools for the Diagnosis of Female Gynecological Cancers and Precancers. • US Patent Application No. 61/581,350. Filed Dec. 29, 2011. Methods for Detecting Human Papilloma VirusAssociated Cancers. • US Patent No. 8,883,414. Filed May 17, 2012. • US Patent No. 8,865,882. Filed Sept. 7, 2011. • US Patent No. 9,157,129. Issued Oct. 13, 2015. • European Patent No. US/2012/0202200. Pub. Aug. 9, 2012.

MatBA® CGI’s Mature B-cell Array Tool for Diagnosis and Prognosis of Mature B-Cell Neoplasms. • US Patent No. 8,557,747. Filed Dec. 29, 2010. • US Patent No. 8,580,713. Filed May 18, 2012. • European Patent Application Nos. 14199582.9 and 10803548.6. Filed Dec. 29, 2010. • Indian Patent Application No. 6657/DELNP/2012. Filed Dec. 29, 2010. • Canadian Patent Application No. 2,785,656. Filed Dec. 29, 2010.

TOO® CGI’s Tissue of Origin® Test Systems and Methods for Detecting Biological Features. • US Patent No. 8,977,506. Issued Mar 10, 2015. • US Patent No. 8,321,137. Issued Nov 27, 2012. • US Patent No. 7,747,547. Issued June 29, 2010. • US Patent No. 8,473,217 Issued June 25,2013.

UroGenRA® CGI’s Urogenital Cancer Array Panel for the Detection and Differentiation of Renal Cortical Neoplasms. • US Patent No. 8,716,193. Filed Nov. 13, 2013. • US Patent No. 8,603,948. Filed Oct. 31, 2007. • European Patent Application Nos. 14193756.5 and 08844570.5. Filed Oct. 31, 2008. Methods and Tools for the Diagnosis and Prognosis of Urogenital Cancers. • US Patent Application No. 61/765,678. Filed Feb. 15, 2013.

COLLABORATIONS AND PARTNERSHIPS Partnering with Leading Cancer Research & Academic Centers

CGI has established strong research collaborations with key thought leaders and major cancer centers in the US and abroad. These collaborations enable us to develop and validate proprietary tests in a clinical setting by providing access to robust patient data. Beth Israel Deaconess Medical Center

Groupe Hospitalier Pitié Salpétriêre, Paris

A collaboration between CGI and Beth Israel Deaconess Medical Center was initiated in 2014 to correlate genetic markers to outcome in patients with diffuse large B-cell lymphoma (DLBCL). The study seeks to assess the relationship of shared genetic variants to overall survival in order to develop a robust model of DLBCL patient survival and outcome. Genetic markers validated in the study will be integrated into CGI’s proprietary tests and genetic signature for the prediction of outcome in DLBCL.

Heterogeneity within kidney cancer specimens is being addressed in a collaboration established with Groupe Hospitalier Pitié Salpétriêre, Paris. The variability of genomic alterations assessed by both array-CGH and NGS will be analyzed in independent samples taken from different segments of tumor samples from the same patients to examine the extent of this phenomenon in this cancer. The impact of site of specimen sampling is of high importance in the clinical diagnostic setting.

Cleveland Clinic

Huntsman Cancer Institute, Univ. of Utah

CGI and Cleveland Clinic have been collaborating on a renal cell carcinoma diagnostic test focused on validating genomic biomarkers from DNA. CGI received numerous specimens from the Cleveland Clinic. Associated clinical and laboratory data was used for the validation of CGI’s proprietary microarray, UroGenRA®–Kidney. Samples were analyzed in CGI’s clinical laboratory and resulting data has been published and additional data will be published jointly.

A collaboration has been established with a leading urology clinician to examine and validate genomic biomarkers of response of kidney cancer patients to frontline FDA-approved tyrosine kinase inhibitors. In this collaborative study, CGI is applying both FOCUS::Renal™ and array-CGH to validate polymorphisms associated with response and determine if within this independent geographically distinct dataset of patients, novel biomarkers of response are identified or the clinical relevance of previously identified prognostic genomic biomarkers are substantiated.

Columbia University CGI entered into a collaboration with leading researchers from Columbia University to identify genomic signatures, biomarkers, and novel treatments for myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The collaboration seeks to identify markers to be used in a novel next-generation sequencing (NGS) based panel for the diagnosis and prognosis of MDS and AML, as well as novel therapies to target these diseases.

Kamineni Hospital (India) CGI and Kamineni Hospital are collaborating to evaluate FHACT®, CGI’s proprietary FISH-based HPV-Associated Cancer Test, as a screening tool for the identification of pre-cancerous and cancerous cervical cells. In February of 2014, Kamineni launched FHACT® as a key diagnostic tool in evaluating and managing cervical cancer in its multi-center hospital system.

Keck Medicine of USC

National Cancer Institute

In 2014, CGI entered into a collaboration with a leading pathologist from Keck Medicine of the University of Southern California to evaluate the utility of genomics to assist in the diagnosis and prognosis of DLBCL and FL. The collaboration seeks to identify and validate unique gene copy number changes and mutations assessed by NGS that can serve as additional prognostic markers in DLBCL. Furthermore, novel variants are being identified to assist in sub classification of FL that have potential therapeutic and clinical utility.

The collaboration with NCI was formed to investigate FISH (Fluorescence in situ hybridization) as a screening tool for the detection of HPV-associated pre-cancerous and cancerous cells. NCI provided liquid biopsy specimens for analysis by FHACT®. Results were published jointly.

Memorial Sloan-Kettering Cancer Center Memorial Sloan-Kettering Cancer Center and CGI are engaged in several collaborations across multiple cancer categories. Current collaborative efforts are focused on kidney cancer where projects are investigating multiple aspects of the care of these patients, from improvement of diagnostic and prognostic utility of core needle biopsy genomic analyses by array-CGH and NGS, to evaluation of genomic alterations associated with metastasis, site of metastasis, to prognostic markers of response of patients to frontline therapeutic agents.

Moffitt Cancer Center CGI entered into a series of collaborative studies with leading researchers at Moffitt Cancer Center. The studies will examine a number of genetic variants as predictors for the most common side effects associated with chemotherapy treatment. A second collaboration will examine the role of individual genetic variants in the effectiveness of pain control in cancer. Through these studies, genetic biomarkers found to have clinical significance in predicting CINV and effectiveness of pain control in patients will be integrated into the company’s comprehensive pharmacogenomics panels. These panels will allow clinical trials investigators and oncologists to better tailor treatments to reduce CINV-related side effects. CGI plans on launching a comprehensive next-generation sequencing based panel focused on pharmacogenomics later this year.

North Shore-Long Island Jewish Health System CGI’s partnership with North Shore-Long Island Jewish Health System was established for the clinical validation of CGI’s proprietary microarray, MatBA® -CLL. We are also involved in collaborative studies for additional molecular biomarkers of CLL.

University of Alabama CGI and the University of Alabama School of Medicine entered into a collaboration to investigate biomarkers for primary central nervous system lymphomas (PCNSL). PCNSL is a group of poorly understood, aggressive cancers. The collaboration leverages CGI’s proprietary array-CGH and NGS techniques to investigate genomic changes in PCNSL.

University of Iowa Cancer Center CGI and the University of Iowa are involved in the validation of the DLBCL microarray. Data from these studies have been published and more studies are ongoing.

ONCOSPIRE GENOMICS

Cancer Genetics, Inc. and Mayo Clinicâ&#x20AC;&#x2122;s Joint Venture focused on developing Next-Generation Sequencing for areas of critical need in oncology.

Discover. Personalize. Deliver.

In May 2013, CGI and Mayo Clinic launched Oncospire Genomics, an equally owned joint venture. Oncospire is currently working on the development of novel nextgeneration sequencing (NGS) based diagnostic panels that provide clinically relevant and actionable insights in areas of critical need in oncology. The joint-venture will initially pursue the development of NGS panels for lung cancer, multiple myeloma, and follicular lymphoma.

MULTIPLE MYELOMA There are approximately 115,000 new cases of multiple myeloma diagnosed annually, and no comprehensive genomic panel that can be utilized to predict early transformation from monoclonal gammopathy of undetermined significance (â&#x20AC;&#x153;MGUSâ&#x20AC;?) to multiple myeloma. Currently available tests are expensive, invasive, and often require multiple biopsies.

LUNG CANCER With over 1.8 million new cases diagnosed annually, lung cancer is a category where earlier diagnosis and differentiation is critical to improved patient outcomes. To date, only a handful of biomarkers for lung cancer have been identified, and they do not fully address the need for diagnostic and predictive information.

FOLLICULAR LYMPHOMA represents approximately 30% of all non-Hodgkin lymphomas, and is the second most common lymphoma in the U.S. We believe predicting the risk progression of follicular lymphoma is a key unmet clinical need, with a potential market of up to 45,000 tests annually based on disease prevalence and number of biopsies performed.

OUR CLINICAL TEAM Clinical Directors

Rita Shaknovich, MD, Ph.D. Group Medical Director, and Vice President of Hematopathology Dr. Shaknovich joined CGI in 2015. She brings over 10 years of experience in Hematopathology, translational research and experimental therapeutics. The focus of her research has been in epigenetic mechanisms governing normal B cell development and lymphomagenesis. Her PhD work and her postdoctoral training focused on pathobiology of hematologic malignancies. Dr. Shaknovich received her MD and PhD degrees from the Medical Scientist training program in Mount Sinai School of Medicine in New York, after which she completed clinical training in Anatomic Pathology specializing in Hematopathology and finished her post-doctoral training in the laboratory of Dr. Ari Melnick in Weill Cornell Medical College.

Jane Houldsworth, Ph.D. Vice President of Research & Development Dr. Houldsworth joined CGI in 2007. She has over 25 years of experience in translational research and has a long-standing interest in the biology and genetics of lymphoma and more recently renal and HPV-associated cancers. She is an active member of the American Society of Hematology (ASH) and the American Association for Cancer Research (AACR). She also holds a New York State certificate of qualification as a laboratory director for oncology, molecular and cellular tumor markers.

Anna Israyelyan, M.D., Ph.D. Clinical Affairs Manager Dr. Israyelyan joined CGI in 2015. She has over 15 years of extensive cancer research and management experience in industry and academia covering wide range of medical areas, including basic, translational, and clinical research. Anna is an active member of the American Society of Hematology (ASH), the American Association for Cancer Research (AACR), and American Association for the Advancement of Science (AAAS). Dr. Israyelyan has a scientific advisory role with matrix management of scientific, technical, and operational aspects related to various biopharma projects and collaborations involving biomarkers in solid tumors and hematologic malignancies.

Lan Wang, M.D. Medical Director Dr. Wang joined CGI in 2008. She is certified by the American Board of Pathology, as well as Hematopathology. In New Jersey, Dr. Wang holds a Medical License and Bioanalytical Laboratory Director License from the Board of Medical Examiners. She also has a Certificate of Qualification from New York State as a Laboratory Director in Histopathology and Cytopathology. Dr. Wang holds the position of Staff Pathologist/ Hematopathologist and serves as a cancer liaison physician at Chilton Memorial Hospital in New Jersey. She is also responsible for overseeing the pathology and flow cytometry departments at CGI. 16

Frank Bauer, M.D. Associate Medical Director, Staff Hematopathologist Dr. Bauer joined CGI in 2013. With over 15 years of consultant experience with several commercial laboratories, Dr. Bauerâ&#x20AC;&#x2122;s work at CGI is focused on business development in hematopathology. Dr. Bauer is also Director of the Department of Pathology and Laboratory Medicine and the Department of Hematopathology and Transfusion Medicine Subsections at Saint Francis Hospital and Medical Center.

Donghong Cai, M.D., Ph.D. Associate Medical Director, Staff Pathologist Dr. Cai joined CGI in 2013. Dr. Cai is certified by the American Anatomic Pathology and Clinical Pathology Boards, the American Hematology-Pathology Boards and holds medical licenses from New Jersey and New York State. He got his fellowship training in hematopathology at Montefiore Medical Center, was recipient of the Advanced Hematopathology Training Grant from College of American Pathologists and was given the Chairâ&#x20AC;&#x2122;s Award for Excellence in Teaching from the SUNY Downstate Department of Pathology.

Gary Zeger, M.D. Medical Director Dr. Zeger graduated from the New York University School of Medicine. He then completed his residency in anatomic and clinical pathology at Cedars Sinai Medical Center in Los Angeles where he also served as chief resident. Fellowship training was done at Cedars Sinai in surgical pathology and the New York Blood Center in transfusion medicine. Dr. Zeger was director of the blood bank at Bellevue Hospital in Manhattan and assistant medical director of the Los Angeles Red Cross before coming to USC. Dr. Zeger is currently co-medical director of Clinical Laboratories at Keck Hospital of USC were he also serves as medical director of the Blood Bank. He is founder and medical director of the USC Blood Donor Center and medical director of Cancer Genetics Inc.

Weiyi Chen, Ph.D., HCLC (ABB) Director, Molecular Diagnostics Dr. Chen joined CGI in 2005. Dr. Chen trained in the Molecular Research Laboratory at MSKCC and has over 10 years of research experience in the genetics of lymphoma and 9 + years of experience in clinical molecular diagnostics. Dr. Chen is certified as a High-Complexity Clinical Laboratory Director (HCLD) and Clinical Consultant (CC) from the American Board of Bioanalysis (ABB) and holds a certificate of qualification as a laboratory director for oncology, molecular, and cellular tumor markers from the New York State Department of Health. She is an active member of the Association of Molecular Pathology. 17

OUR CLINICAL TEAM Clinical Directors

Pal Singh-Kahlon, Ph.D., FACMG Director, Cytogenetics Dr. Singh-Kahlon joined CGI in 2010 and has more than 20 years of experience in the field of clinical cytogenetics. Dr. Singh-Kahlon is recognized as a leader in the field of cytogenetics and has experience from both academic institutions and reference laboratories. Dr. Singh-Kahlon is board certified in clinical cytogenetics by the American Board of Medical Genetics and holds a Certificate of Qualification (COQ) for the states of New York and New Jersey.

V. Subhadra Nandula, Ph.D., FACMG Associate Director, Cytogenetics Dr. Nandula came to CGI in 2012. Her focus has been on human genetics and especially cytogenetics for over 19 years. She is certified by the American Board of Medical Genetics with a subspecialty in clinical cytogenetics. Dr. Nandula has more than 11 years of experience in cytogenetics of hematological malignancies and also holds a Certificate of Qualification from the New York Department of Health in Cytogenetics.

Charles Ma, Ph.D. Principal Clinical Scientist Dr. Ma joined CGI in 2010. He has over 10 years of experience in the biotech industry focusing on translational research. He is a member of the Association for Molecular Pathology (AMP) and holds a New York State certificate of qualification as a laboratory director for oncology, molecular and cellular tumor markers. Dr. Ma earned his Ph.D. degree in Molecular Biology from the University of California, Los Angeles.

OUR BIOPHARM TEAM Experienced Leadership

Kamala Maddali, DVM, Ph.D. Vice President, Biopharma Collaborations & Companion Diagnostics Dr. Cai joined CGI in 2015. Dr. Maddali brings over 10 years of extensive experience of global P&L scientific and commercial management of clinical biomarker and companion diagnostics (CDx) services covering personalized medicine strategy. She has promoted the proper utilization of biomarkers, personalized medicine and diagnostics in drug development and patient management to bridge the gap between drug and diagnostic industries. She was Global Director Scientific Development -Biomarkers & Companion Diagnostics for Q2 Solutions (A Quintiles & Quest Diagnostics joint venture). She brings a lot of strategic values from her previous roles at Quest Diagnostics, Quintiles and Merck Schering Plough in the arena of biomarkers and companion diagnostics. Dr. Maddali holds a DVM Ph.D., in Pharmacology from University of Missouri-Columbia and a DVM Veterinary Medicine from Acharya N.G. Ranga Agricultural University in India.

Narasimha Marella, Ph.D. Vice President of Operations Dr. Marella joined CGI in 2010. His research interests were in investigating the three dimensional structural and functional architecture of the human nucleus in normal and cancer cell types. While involved in Corporate Business Development, Dr. Marella led CGI’s Clinical Trial initiative (SELECT ONE) along with members from the research and clinical lab departments. Since June 2015, he is leading the operations of CGI’s Rutherford, New Jersey facility in addition to continuing managing several business development projects of strategic importance to the growth and expansion of CGI. Dr. Marella earned his PhD in Biological Sciences from University at Buffalo, New York and obtained his Master’s degree in Biotechnology from Andhra University, India.

Rob Fannon, MBA, MPH Vice President of Operations Rob joined CGI in 2014. Rob Fannon brings more than 10 years of experience in operations, client management, molecular test and panel development, and biorepository management to CGI. Before joining CGI, Mr. Fannon served with Roche Molecularâ&#x20AC;&#x2122;s Biospecimen Management Division, where he oversaw biospecimen acquisition, panel production, project management, and client relations. Prior to his tenure at Roche, Fannon served as clinical operations manager at BioServe Biotechnologies, Ltd. In Beltsville, MD, where he was responsible for sales, business development, and client relations. From 2006 to 2010, Fannon served as an editor and analyst at Stansberry and Associates Investment Research, where he established an investment advisory publication focused on investment opportunities in publicly-traded biotech, life science, and healthcare companies. Fannon also spent two years as a business development associate at the Johns Hopkins Bloomberg School of Public Health, where he assessed intellectual property opportunities and sought licensing opportunities for research with provisional patent coverage. Mr. Fannon received his B.S. from East Carolina University and holds a Master of Public Health (MPH), and a Master of Business Administration (MBA) from Johns Hopkins University in Baltimore, MD.

OUR LOCATIONS

RUTHERFORD, NJ LOS ANGELES, CA

SHANGHAI, CHINA RALEIGH, NC

HYDERABAD, INDIA

New York Metro Located at CGI’s corporate headquarters in Rutherford, NJ, CGI Laboratories provides clinical testing services and is home to our world-renowned R&D department. Our Rutherford, NJ laboratory is HIPAA compliant, CLIA-certified, CAP-accredited, and holds licensure in several US states.

Research Triangle Park Located in Raleigh, NC, CGI’s Research Triangle Park location provides clinical trials testing, pharmacogenomic testing, and biorepository services. Our Raleigh, NC facility is CLIA-certified, is GLP-compliant, and follows ISBER Best Practices. The facility also boasts a CAP-accredited biorepository.

Los Angeles, California Located in Los Angeles, CA, CGI’s southern California location provides proprietary tests and panels for lung, colon, gastric cancer, and melanoma, as well as the FDA-cleared Tissue of Origin® (TOO® ) test. Our Los Angeles, CA facility is CLIA-certified, GLP-compliant, CAP-accredited, and holds licensure in several states.

Hyderabad, India Based in Hyderabad, India, Cancer Genetics India delivers CGI’s cancer diagnostics to the Indian market. Specializing in next-generation sequencing, biomarker discovery and validation, DNA extraction and sequencing, and GMO testing, Cancer Genetics India is an important partner for a number of clinics, hospitals, and research institutions in India.

Shanghai, China Located in Zhangjiang Hi-Tech Park in Shanghai, our China facility provides clinical trials services for companies engaged in global or China-specific clinical trials. CGI’s China facility meets or exceeds all local regulatory compliance expectations and is both CLIA-certified and CAP-accredited. 22

TESTING SERVICES 23

OVERVIEW OF CLINICAL TESTING SERVICES

Technology Agnostic, Methodologically Complete At Cancer Genetics, we know that clinicians, patients, and their families rely on us to provide the most advanced and comprehensive testing available.

Comprehensive Clinical Testing Through our CLIA-certified, CAP-accredited clinical laboratories, we offer comprehensive testing for both solid tumor and hematological cancers. We utilize an expansive range of tests and technologies to provide the most comprehensive profile for each patient we serve. Clinical testing is available for anatomic pathology, flow cytometry, cytogenetics, FISH, and molecular diagnostics (including next-generation sequencing).

CGI’s Specialty Tests Cancer Genetics has developed a number of proprietary tests for difficult-to-diagnose cancers including B-cell neoplasms, urogenital cancers, and HPV-associated cancers.

MatBA® CGI’s Mature B-cell Neoplasm Array Available for CLL/SLL, DLBCL, FL, MCL.

UroGenRA® CGI’s Urogenital Cancer Array Available for Kidney Cancer.

Complete™ Programs

FHACT®

Cancer Genetics’ Complete™ offering is a unique suite of common and proprietary tests that assists clinicians in determining the best treatment options to improve patient outcomes. Each program integrates the latest diagnostic and prognostic biomarkers across multiple methodologies. CGI offers Complete™ testing for a number of hematological neoplasms and solid tumor cancers, including AML, CLL, DLBCL, MCL, MDS, MPN, colorectal, lung, and breast.

CGI’s FISH-based HPV-Associated Cancer Test Available for Cervical Cancer.

Expand Dx™ Technical-Only Testing

TOO®

CGI’s technical-only testing service allows communitybased hospitals and pathology labs to access the most advanced testing technologies available while managing costs for their patients. Testing technologies available through the Expand Dx™ technical-only program include digital pathology (IHC, ISH, AP) fluorescence in situ hybridization (FISH), and flow cytometry.

CGI’s Tissue of Origin® Test Available for solid tumor testing (thyroid, breast, nonsmall cell lung, pancreas, gastric, colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma, melanoma, ovarian, sarcoma, testiclular germ cell, and prostate).

Focus::NGS™ CGI’s Next-Generation Sequencing Panel Available for Lymphomas, Myeloid Malignancies, and Solid Tumors (such as lung, colon, skin, breast, and bladder cancers and diagnosis/prognosis use in thyroid cancer).

OUR UNIQUE TESTS

MatBA® for Mature B-cell Neoplasms

Predict Outcome for B-cell Neoplasms Microarray based technology assesses a large number of genetic alterations in a single experiment. One application of this technology, known as array-CGH, is utilized to evaluate DNA copy number changes (gains/ losses) observed frequently in tumor genomes.

MatBA®-CLL/SLL

The Mature B-cell Neoplasm Array (MatBA®) utilizes Array-CGH technology and has been designed to detect chromosomal gains and losses at 80 specific genomic sites associated with mature B-cell neoplasms. MatBA® is optimized for use on a range of specimen types such as peripheral blood, bone marrow, cell suspension, and formalin-fixed paraffin-embedded tissue specimens.

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MatBA® improves prognostication by determining each patient’s unique genetic profile, allowing doctors to more accurately select the best treatment options.

MatBA®-FL

Advantages of MatBA®

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• • • •

Higher resolution that FISH (1-2 Kb vs. 100 Kb) Detects multiple distinct genomic aberrations in one hybridization (gain and loss) Identifies alterations not currently assessable by other techniques Identifies more abnormalities than FISH. For instance, MatBA®-CLL/SLL detects more abnormalities than FISH in 30% of CLL cases

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Identifies information on 20 distinct chromosomal regions Provides prognostic outcome and can stratify patients into three prognostic groups (good / intermediate / poor) Can help clinicians determine best course of action

MatBA®-DLBCL • • •

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Assesses 15 distinct chromosomal regions Can predict whether the patient has overall adverse outcome Assists in the prediction of treatment response

Assesses 14 genomic biomarkers Can predict whether the patient will respond favorably to treatment Assists clinicians in determining best treatment options

MatBA®-MCL • • •

Tests for 9 genomic biomarkers Can predict whether the patient has overall adverse outcome Assists clinicians in determining the best treatment options

Publications

Patents

“Genomic Imbalance Defines Three Prognostic Groups for Risk Stratification of Chronic Lymphocytic Leukemia Patients.”

• • •

Houldsworth J, et. al. Leukemia & Lymphoma, April 2014; 1-9

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Specimen Requirements

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One EDTA tube (lavender) of peripheral blood or bone marrow aspirate with minimum 2-3ml or 3-5 FFPE sections at 10µm thickness on regular slides or in a tube. Stored and transported at room temperature.

US Patent No. 8,557,747. Filed Dec. 29, 2010. US Patent No. 8,580,713. Filed May 18, 2012. European Patent Application Nos. 14199582.9 and 10803548.6. Filed Dec. 29, 2010. Indian Patent Application No. 6657/DELNP/2012. Filed Dec. 29, 2010. Canadian Patent Application No. 2,785,656. Filed Dec. 29, 2010.

Turn Around Time 10-14 days

OUR UNIQUE TESTS

UroGenRA® for Kidney Cancer

Go Beyond Diagnosis. UroGenRA®, CGI’s custom oligonucleotide array product line, is designed to detect genomic copy number alterations (CNA) with prognostic and diagnostic value in kidney, prostate and bladder cancers UroGenRA®-Kidney is specifically designed to classify renal tumors into three major malignant subtypes and one benign: clear cell renal cell carcinoma (ccRCC), papillary RCC (pRCC), chromophobe RCC (chrRCC), oncocytoma (OC). By accurately diagnosing and subtyping renal tumors, UroGenRA®-Kidney helps guide doctors in the clinical management of their patients and may help reduce unnecessary nephrectomy for patients with benign tumor.

KidneyPathTM

Patents Panel for the Detection and Differentiation of Renal Cortical Neoplasms. • US Patent No. 8,716,193. Filed Nov. 13, 2013. • US Patent No. 8,603,948. Filed Oct. 31, 2007. • European Patent Application Nos. 14193756.5 and 08844570.5. Filed Oct. 31, 2008. Methods and Tools for the Diagnosis and Prognosis of Urogenital Cancers. • US Patent Application No. 61/765,678. Filed Feb. 15, 2013.

Publications “Subtyping of renal cortical neoplasms in fine needle aspiration biopsies using a decision tree based on genomic alterations detected by fluorescence in situ hybridization” Banumathy Gowrishankar, et. al.

Results from the UroGenRA -Kidney test are analyzed using CGI’s proprietary algorithm, KidneyPathTM. Specimens classified “normal” by the decision tree are reflexed to FISH (CCND1 break apart) in order to rule in/out OC subtype. ®

KidneyPathTM was validated using over 100 fresh frozen RCC specimens (surgically-resected) and needle biopsy specimens (MSKCC), publicly available data and published literature, and the Cancer Genome Atlas (TCGA) database, which contains more than 500 specimens.

BJU International 2014 Dec; 114(6):881-90.

Specimen Requirements Biopsy: minimum 3-4 needle/core biopsies (18-gauge needle) placed in a cryovial containing saline, transport frozen. (Minimum 70% tumor population). Resected Specimen: minimum of 0.2 cm3 tissue, snap-frozen in a cryovial and transported in frozen condition. (Minimum 70% tumor population).

Turn Around Time 10-14 days

OUR UNIQUE TESTS

FHACT® for Cervical Cancer

Take the Guess Work Out of Cervical Cancer Testing Fluorescence in situ hybridization (FISH) is used to detect chromosomal aberrations such as DNA copy number changes (gain/loss) and rearrangements (translocation/break apart). FISH is a method of choice for diagnosis, prognosis, and treatment response prediction for a number of hematological and solid tumor cancers.

Methods for Detecting Human Papilloma VirusAssociated Cancers. • US Patent No. 8,883,414. Filed May 17, 2012. • US Patent No. 8,865,882. Filed Sept. 7, 2011 • European Patent No. US/2012/0202200. Pub. Aug. 9, 2012.

Publications CGI’s FISH-based HPV-Associated Cancer Test (FHACT®) is the only four color FISH probe available for cervical cancer testing. When used as an additional triage before colposcopy, FHACT® can help identify those women most at risk for cervical cancer. By reducing the number of unnecessary colposcopies performed, FHACT® helps reduce complications associated with over treatment and reduces healthcare costs.

No Resampling Necessary FHACT® is non-invasive and is performed on leftover liquid-based cytology and conventional Pap smears, so no resampling is necessary.

Patents Methods and Tools for the Diagnosis of Female Gynecological Cancers and Precancers. • US Patent Application No. 61/581,350. Filed Dec. 29, 2011.

“Chromosomal gains measured in cytology samples from women with abnormal cervical cancer screening results” Luhn P, et. al. Gynecologic Oncolgy; 2013 Sep; 130(3):595-600. FHACT: the FISH-based HPV-associated cancer test that detects nonrandom gain at four genomic loci as biomarkers of disease progression Jane Houldsworth Expert Review of Molecular Diagnostics; 2014; 1-14.

Specimen Requirements Liquid cytology in PreservCyt or SurePath. Specimens may be shipped at room temperature (≤ 25˚C) but shipping at 4˚C is recommended. Specimens shall not be frozen. Specimen volume recommended >10 mL.

Turn Around Time 10-14 days

FHACT® assesses non-random genomic alterations associated with progression of cervical disease Positive for Gain of FHACT® Regions POSITIVE FHACT® RESULT

Referred for colposcopy

Negative for Gain of FHACT® Regions NEGATIVE FHACT® RESULT

No colposcopy required at this time

OUR UNIQUE TESTS

Next-Generation Sequencing

Access the Next-Generation of Cancer Diagnostics.™ One of the major challenges in diagnosing hematological and solid tumor cancers is the high degree of tumor heterogeneity. Mutations that have critical clinical implications may only be present in very low levels, making detection of these mutations difficult. Detection of such mutations is especially important in hematological malignancies, where tumors show a great deal of heterogeneity and accurate prognosis is essential to identifying patients with more aggressive disease. Next-generation sequencing (NGS) helps respond to these challenges by providing a comprehensive view of the tumor’s genomic profile. Importantly, NGS can detect multiple mutations present at very low levels within the tumor.

Solid Tumors NGS Panel Focus::Oncomine™ The Focus::Oncomine™ NGS panel includes 47 genes and provides treatment guidance for solid tumors such as lung, colon, skin, breast, and bladder cancers and diagnosis/prognosis use in thyroid cancer.

Lymphoma NGS Panels Targeted NGS Panels for B-Cell Lymphomas CGI’s Lymphoma NGS panels provide as powerful and clinically validated tools for the molecular characterization of lymphomas. The targeted NGS panels in the table below report on clinically actionable gene mutations present in the most common types of B-cell lymphomas, representing nearly 300,000 patients living with the disease in the USA. These Focus::NGS™ panels for lymphoma have been used to power several clinical trials with biopharmaceutical companies and are also available for routine clinical management and therapy selection for lymphoma patients. The Lymphoma Extended™ NGS panel is also available to report on 220 gene mutations associated with and being researched for lymphoma. Lymphoma NGS Panels # of Genes Indication Focus::CLL™

Chronic Lymphocytic Lymphoma

Focus::MCL™

Mantle Cell Lymphoma

Focus::DLBCL & FL™

Diffuse Large B-Cell Lymphoma & Follicular Lymphoma

Focus::Lymphoma™

Other Subtypes of Lymphoma

Lymphoma Extended™

220

Full Lymphoma Research Panel

Specimen Requirements FFPE block or 5-10 FFPE sections at 10 μm thickness on positively coated slides shipped at room temperature, with H&E slide(s). Please submit 15 sections for small biopsies. The tumor tissue must be ≥ 20% tumor cells for accurate test results.

Turn Around Time 7-10 days

Specimen Requirements One Lavender (EDTA) tube of peripheral blood or bone marrow aspirate (2-3 ml) shipped at room temperature or 2-8 °C.

Turn Around Time 10-14 days

Myeloid NGS Panels Targeted NGS Panel for Myeloid Malignancies CGI’s unique Myeloid NGS panels provide actionable information for improved diagnosis, prognosis, and risk stratification for myeloid malganancies including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN). Based on the Focus::NGS™ result, each patient can receive the most suiteable treatment tailored to their unique cancer. By personalizing diagnosis and improving risk stratification, the Myeloid NGS panels deliver on the promise of precision medicine. Myeloid NGS Panels

# of Genes

Indication

Focus::AML™

Acute Myeloid Leukemia

Focus::MDS

Myelodysplastic Syndrome

Focus::MPN

Myeloproliferative Neoplasms

Focus::Myeloid

Other Myeloid maligancies

™ ™

™ Specimen Requirements

One Lavender (EDTA) tube peripheral blood or bone marrow aspirate (2-3 ml) shipped at room temperature.

Turn Around Time 10-14 days

OUR UNIQUE TESTS TOO® for Solid Tumors

TOO ®

Tissue of Origin®

Diagnostic Accuracy & Confidence in Site-Specific Treatment Decisions Mestastatic tumors with an uncertain primary site can be a difficult clinical problem. In tens of thousands of patients every year, no confident dianosis is ever issued, making standard-of-care treatment impossible. Tissue of Origin® FDA-cleared test reports the most likely tissue of origin of 58 morphologic subtypes from 15 of the most common tumor types: thyroid, breast, non-small cell lung, pancreas, gastric, colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma, melanoma, ovarian, sarcoma, testicular germ cell, and prostate.

Specimen Requirements FFPE block containing at least 1 mm2 of tumor tissue by area and an H&E stained slide if possible. Unstained slides of at least 5 μm thickness (10 μm thickness preferred) that contain no less than 1 mm2 of tumor tissue.

Turn Around Time 5-11 days 1.

Validation and reproducibility of microarray-based gene expression test for identifying the primary site of tumors in

TOO® is a Medicare-remibursed test and provides extensive analytical and clinical validation for statistically significantly improvement in accuracy over other methods, including IHC2. In challenging cancers that require a second round of IHC, TOO® increases diagnostic accuracy and confidence in site-specific treatment decisions.1 Tissue of Origin® leads to change in patient treatment 65% of time.

Patents Systems and Methods fo Detecting Biological Features. • US Patent No. 8,977,506. Issued Mar 10, 2015. • US Patent No. 8,321,137. Issued Nov 27, 2012. • US Patent No. 7,747,547. Issued June 29, 2010. • US Patent No. 8,473,217 Issued June 25,2013.

formalin-fixed paraffin-embedded specimens. R Pillai, R Deeter, CT Rigl, JS Nystrom, M Halks Miller, L Buturovic, WD Henner. J Molec Diag 13 2011;13:48-56 2.

A multicenter study directly comparing the diagnostic accuracy of gene expression profiling and immunohistochemistry for primary site identification in metastatic tumors. CR Handorf, A Kulkarni, JP Grenert, L Weiss, W Rogers, O Kim, F Monzon, M Halks-Miller, G Anderson, M Walker, R Pillai, WD Henner. Am J Surg Pathol 2013;37:1067

Clinical utility of gene-expression profiling for tumor-site origin patients with metastatic or poor differentiated cancer: impact on diagnosis, treatment, and survival. JS Nystrom, J Hornberger, G Varadhachary, R Hornberger, H Gutierrez, WD Henner, S Becker, M Amin, M Walker. Oncotarget 2012 Jun;3(6):620-8

O igin O T Or

f o e

d e u r s a Tis DA-Cle F

COMPLETE™ TESTING

The Right Therapy for Each Patient the First Time®

Comprehensive Testing, Integrated Results. Cancer Genetics’ Complete™ programs offer a unique suite of common and proprietary tests which can assist clinicians in determining the best treatment options to improve patient outcomes. Each program integrates the latest diagnostic and prognostic biomarkers across multiple methodologies. Compete testing is performed in CGI’s state-of-the-art CLIA-certified, CAP-accredited laboratories. AML Complete™ Acute myeloid leukemia (AML) is a bone marrow cancer that progresses rapidly creating a therapeutically challenging disease to accurately diagnose and prognosticate. Bone marrow analysis with cytogenetics is used to predict remission rates, relapse risks, and overall survival outcomes. Molecular markers such as mutations and small insertions/deletions exhibit clinical relevance by helping to refine prognostic groups. Common molecular markers include CEBPA, FLT3-ITD, cKIT, and NPM1. AML Complete™ testing includes: • Molecular Pathology • Focus::AML™ (NGS) • CEBPA, FLT3, cKIT, NPM1 Mutation Analysis

• Morphology • Flow Cytometry • Myeloid/Lymphoid Panel • IHC Evaluation • Karyotyping • FISH-AML Panel

Breast Complete™ Breast cancer subtyping is critical to determining the appropriate targeted therapy option for each patient. By offering the most comprehensive testing panel available, CGI’s Breast Complete™ program can help determine the best personalized course of action for each patient. Breast Complete testing includes: ™

• IHC Evaluation • Focus::Oncomine™ (NGS) • HER2 Mutation

CLL Complete™ Accurate prognostication of CLL patients is essential in order to determine the most effective course of treatment. CLL patients tend to display significant clinical heterogeneity -some patients have aggressive disease requiring careful active monitoring or treatment at diagnosis, while others exhibit a more indolent (slowly progressing) course of disease. CGI’s Complete testing program for CLL/SLL integrates the latest diagnostic and prognostic molecular markers, including CGI’s proprietary array-CGH based panel, MatBA®-CLL/SLL, and our NGS-based panel, Focus::CLL™. CLL Complete™ testing includes: • Molecular Pathology • Focus::CLL™ (NGS) • IGHV Mutation • MatBA®-CLL/SLL • NOTCH1 Mutation

• SF3B1 Mutation • TP53 Mutation • Morphology • Flow Cytometry • ZAP-70; CD38 • Karyotyping • FISH-CLL Panel

Colorectal Complete™ CGI’s Complete™ Program colorectal cancer (CRC) assists in determining the best personalized course of action for the patient by predicting overall prognosis and treatment response. CRC Complete™ also risk stratifies patients for likelihood of developing Lynch Syndrome leading to earlier CRC screening and diagnosis for those identified as high risk. CRC Complete™ testing includes: • KRAS Mutation • NRAS Mutation • BRAF Mutation • IHC Evaluation • Focus::Oncomine™ (NGS)

DLBCL Complete™ DLBCL is a clinically, pathologically, and genetically heterogenous disease – meaning that patients display a diverse range of clinical symptoms, pathological presentation, and genetic mutations. While DLBCL is an immunochemo-sensitive disease, only about 60% of patients are cured. Therefore, risk stratification is highly desirable for DLBCL patients in order to differentiate those who are likely to have refractory disease or relapse from those who may be cured with the standard therapy. CGI’s complete program for DLBCL integrates the latest diagnostic and prognostic molecular markers, including CGI’s proprietary MatBA®-DLBCL, in order to risk stratify individual patients for disease progression, response to treatment, and overall prognosis. DLBCL Complete™ testing includes: • Molecular Pathology • Focus::DLBCL™ (NGS) • MatBA®-DLBCL • TP53 • B-Cell Clonality • Morphology • Flow Cytometry • Lymphoid Panel

• Karyotyping • FISH Panel • NHL Panel • IHC Evaluation • GCB vs. Non-GCB Subtyping • MYC, Ki-67, p53, Bcl-2, Bcl-6, CD30, EBER

Lung Complete™ Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancers, with more than 185,000 new cases diagnosed in the US each year. It is estimated that ~40% of lung cancer tumors are driven by certain genetic mutations that could be targets for specific drugs. Genetic testing for these mutations can provide important insight into a patient’s disease, and help determine an individual’s diagnosis, prognosis, and whether they are likely to respond to certain treatments. Lung Complete™ testing includes: • Morphology • KRAS, BRAF, HER2 • EGFR Mutation Mutation • ALK-Break Apart FISH • RET FISH Probe Probe • IHC Evaluation • ROS1 FISH Probe • Focus::Oncomine™ (NGS) • MET FISH Probe

MDS Complete™ Myeloproliferative neoplasms (MPN) correspond to a group of blood cancers that include chronic myelogenous leukemia (CML), primary myelofibrosis (PMF), polycythemia vera (PV), essential thrombocythemia (ET), hyper eosinophilia and mast cell disorders. Most cases develop slowly, and some MPNs can progress to leukemia. In addition to the patient’s general clinical features, the treatment depends upon the MPN subtype, therefore determining the right MPN subtype is critical. MDS Complete™ testing includes: • Molecular Pathology • Myeloid/Lymphoid Flow • Focus::MDS™ (NGS) Panel • Morphology • IHC Evaluation • Flow Cytometry • Karyotype • FISH-MDS Panel MPN Complete™ By offering the most comprehensive testing panel available, CGI’s MPN Complete™ Program can help in determining the best personalized course of action for the patient. Tests being offered in the Complete™ Programs include biomarkers that rely on various methodologies and that have diagnostic and prognostic significance for each patient. MPN Complete™ testing includes: • Molecular Pathology • Focus::MPN™ (NGS) • Morphology • Flow Cytometry • Myeloid/Lymphoid Panel • FISH-MPN OR MPN/MDS Panel

• IHC Evaluation • CD34, CD117, MPO, Muramidase, Glycophorin A, mast cell tryptan, CD25 • Karyotyping • Focus::Myeloid™ (NGS) • JAK2 V617F Mutation • JAK2 Exon 12 Mutation • MPL 515/505 Mutation • cKIT D816 Mutation • CALR Mutation-ET/PMF • Quantitative BCR-ABL1 Mutation (PCR)

TECHNICAL-ONLY TESTING Innovating the Way You Diagnose Patients About Expand Dx™ The Expand Dx™ program is a partnership initiative offered by CGI to help community hospitals and clinics expand their clinical services. By partnering with CGI Laboratories™, community-based hospitals and pathology labs can provide the same cuttingedge technology and testing available at large cancer centers, and reduce the burden of travel and cost for their patients. Expand Dx™ works to build on laboratories’ capabilities to increase efficiency, drive revenue, and help community-based hospitals and clinics stay competitive in today’s evolving market. Gain Access to CGI’s CLIA and CAP Accredited Technical-Only Testing CGI’s oncology-focused laboratory is committed to providing patients and providers with the highestquality testing services. Through CGI’s technical-only testing service, pathologists and clinicians are able to access the most advanced testing technologies available, and leverage CGI’s unique expertise in hematological and solid-tumor oncology diagnostics.

CGI’s Expand Dx™ technical-only testing ensures that clinicians and pathologists have the tools they need to better diagnose their patients. By providing more flexible ordering options, technical-only testing helps healthcare providers manage costs for their patients, and allows for increased collaboration on difficult cases. Technical Only Test Reports Technical-only test results can be accessed through CGI’s secure, HIPAA compliant web portal. For providers interested in leveraging technical-only testing, CGI will help set up secure access to the system. With technical-only testing, pathologists and clinicians are able to sign out cases remotely, saving them valuable time and resources.

With CGI’s technical-only testing service, specimens are sent to CGI Laboratories, where the technical component of testing is performed. Clinicians can then access the test results through an online portal in order to perform the professional component and provide a diagnosis.

ANATOMIC PATHOLOGY ANATOMIC PATHOLOGY In addition to special staining, we offer both tissue in situ hybridization (ISH) and a full immunohistochemistry (IHC) library including over 150 antibodies (see next page) with a core expertise in hematological tumors and common solid tumors. IHC stains can be ordered as global or technical component only.

Antibody Listing • Actin, α-Smooth Muscle

• CD34

• Fascin

• MLH1

• Actin, Muscle Specific

• CD35

• FGF2

• MOC31

• PR

• ALK1

• CD43

• FLI-1

• MSH2

• Prostate Acid Phosphatase (PSAP) • Prostate Triple Stain

• ALK (IHC) D5F3 FDA (crizotinib)

• CD45 (LCA)

• Foxp1

• MSH6

• Alpha Fetoprotein (AFP)

• CD45RA

• Gastrin

• MUC2

• Annexin A1

• CD45RO

• GCDFP-15

• MUC5AC

(ck903, p63 & Racemase) • PSA

• Basal Cell Cocktail

• CD56

• GCET-1

• MUC6

• PSAP

• Bcl-2

• CD57

• GFAP

• MUM1

• Pyloric

• Bcl-6

• CD61

• Glucagon

• Myelin Basic Protein

• RCC

• BRAF

• CD68

• Glycophorin A

• Myeloperoxidase (MPO)

• S100 • SMMHC

• Beta-catenin

• CD79a

• Glypican 3

• MyoD

• BOB-1

• CD99

• Granzyme B

• Myogenin

• Somatostatin

• BCL2-Break Apart

• CD117 (c-KIT)

• HBME-1

• Myoglobin

• Sox11

• Breast Triple Stain

• CD138 (Syndecan-1)

• hCG

• Napsin A

• Synaptophysin

• CD163

• Helicobacter pylori

• Neurofilament (NF)

• TAG-72

• c-MET

• CDX-2

• HepPar-1

• Neuron Specific Anolase (NSE)

• TdT

• c-MyC

• Chromogranin A

• HER-2/neu (IHC)

• Oct-2

• Thrombomudulin

(CK5+p63+CK8/18)

• Podoplanin (D2-40)

• CA 19-9

• CMV

• HER-2 (ISH)

• Oct-3/4

• Thyroglobulin

• CA 125

• Cyclin D1(BCL-1)

• HHV-8

• p16 INC4A

• TIA-1 • Toxoplasma

• Calcitonin

• Cytokeratin (CAM 5.2)

• HMB-45

• Double Stain (p16/Ki-67)

• Caldesmon

• Cytokeratin (Pan) (AE1/AE3)

• HPV Probe ISH

• p53

• TTF-1 Thyroid Transcription

• Calponin-1

• Cytokeratin 903 (34βE12)

• HSA

• p57

• TRAcP

• Calretinin

• Cytokeratin 14

• HSV I

• p63

• Tryptase

• CEA (m)

• Cytokeratin 17

• HSV II

• p120

• Tyrosinase • Uroplakin III

• CEA (p)

• Cytokeratin 19

• IgA

• p504S (Racemase)

• CD1a

• Cytokeratin 20

• IgD

• Pan-Cytokeratin

• Villin

• CD2

• Cytokeratin 5 & 6

• IgG

• Parathyroid Hormone (PTH)

• Vimentin • WT1

• CD3

• Cytokeratin 7

• IgG4

• Parvovirus B19

• CD4

• Cytokeratin 8 (34BH11)

• IgM

• PAX-2

• CD5

• Cytokeratin 8 & 18

• Inhibin, alpha

• PAX5 (BSAP)

• CD7

• DBA44

• Insulin

• PAX8 • PD-1

• CD8

• Desmin

• Kappa

• CD10 (CALLA)

• DOG-1

• Kappa By ISH

• PD-L1 22C3 FDA (Keytruda®)

• CD14

• EBER (ISH)

• Ki-67

• PD-L1 28-8 FDA (Opdivo®)

• CD15

• E-cadherin

• Lambda

• PD-L1SP263 (non-lung, LDT)

• CD20

• EGFR

• Lambda By ISH

• PD-L1 SP142 FDA (Tecentriq™) • Perforin

• CD21

• EMA

• LMO2

• CD22

• Ep-CAM (BER-EP4)

• Lysozyme (muramidase)

• Placental Alkaline

• CD23

• ER

• Mammaglobin Cocktail

• Phosphatase (PLAP) • PLAP

• CD25

• Factor-1

• Melan A (MART-1)

• CD33

• Factor VIII Rel. Antigen

• Melanoma HMB-45

• PMS2

• CD31

• Factor XIIIa

• Mast cell tryptase

• Pneumocystis carinii

FLOW CYTOMETY FLOW CYTOMETRY PANELS Lymphoid Panel CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11c, CD19, CD20, CD23, CD38, CD45, CD56, CD57, sKappa, sLambda

Myeloid Panel CD11b, CD13, CD14, CD15, CD16, CD22, CD33,CD34,CD64,CD71, CD117, HLA-DR

Acute Leukemia Panel [Reflex] cMPO, cCD79a, cCD3, cTdT, CD1a, cCD22, CD45

Hairy Cell Leukemia [Reflex] CD20, CD25, CD45, CD103

ZAP-70 Panel [Reflex] CD3, CD5, CD19, cZAP-70, CD45

MRD-CLL CD3, CD5, CD19, CD20, CD22, CD38, CD43, CD45, CD79b, CD81 sLambda, sKappa

Multiple Myeloma Panel CD3, CD4, CD5, CD7, CD8, CD10, CD19, CD20, CD28, CD34, CD38, CD45, CD56, CD117, CD138, sKappa, sLambda, cKappa, cLambda, clgM, clgA, clgG

Paroxysmal Nocturnal Hemoglobinuria Panel CD14, CD15, CD24, CD33, CD45, CD59, FLAER

Also Available CD25, CD30, CD37, CD41, CD49d, CD61, CD235a, FMC7, HLA-ABC, ROR-1, cIGD

CYTOGENETICS KARYOTYPE Karyotyping enables genome-wide detection of aberrations at low resolution that have diagnostic and prognostic significance. Diagnosis and prognosis in cytogenetics includes karyotyping with reflex to FISH.

Normal Karyotype

Abnormal Karyotype

49, XY, der(1;6)(q10;p10), +der(1;6)(q10;p10), +3, t(8;22)(q24;q11.2), -13, +15, +18

46,XY

FISH TESTING SOLID TUMORS Bladder Cancer

Gastric Cancer

Brain Cancer

Lung Cancer

Breast Cancer

Non-Small Cell Lung Cancer (NSCLC)

UroVysion® [FDA-Cleared] PTEN, 1p/19q Deletion PathVysion® (HER2/neu) [FDA-Cleared], FGFR1, PTEN

Cervical Cancer FHACT®

Colorectal Cancer MET

HER2 Amplification ALK, ROS1, MET, RET, FGFR1 ALK-Break Apart [FDA-Cleared], RET, ROS1

Thyroid Cancer RET

FISH

HEMATOLOGICAL MALIGNANCIES Acute Lymphocytic Leukemia (ALL) B-ALL 11q23 (MLL-Break Apart) t(9;22) (BCR/ABL/ASS) CEP4,10, 17 9p21 (CDKN2A [p16]) t(12;21) (ETV6/RUNX1) 17p13 (TP53)

Acute Lymphocytic Leukemia (ALL) T-ALL 14q11 (TCR-Alpha/Delta Break Apart)

Acute Myeloid Leukemia (AML)

11q23 (MLL-Break Apart) t(8;21) (ETO/AML1) [M2] t(15;17) (PML/RARA) [M3] inv(16) (CBFB-Break Apart) [M4, Eos]

Anaplastic Large Cell Lymphoma (ALCL) 2p23 (ALK-Break Apart)

BM Transplant Monitoring CEP X/Y

Chronic Lymphocytic Leukemia (CLL) 11q22.3 (ATM)/17p13 (TP53) CEP12/13q14 (D13S319)/13q34 CEP6/6q23 (c-MYB) t(11;14)(CCND1/IGH)

Chronic Myelogenous Leukemia (CML) t(9;22) (BCR/ABL/ASS)

CML in blast crisis

t(9;22) (BCR/ABL/ASS) 17p13 (TP53) CEP8

Multiple Myeloma (MM)

Multiple Myeloma (MM) - CD138 Plasma Cell Purification 1p/1q IGH-Break Apart* D5S23/D5S7a/CEP7/CEP15 17p13 (TP53) 13q14/13q14 *if positive, reflex to: CCND1/IGH IGH/MAF FGFR3/IGH IGH/MAFB CCND3/IGH

Myelodysplastic Syndrome (MDS) 5q15.2/5q31 CEP7/7q31 20q12 CEP8 11q23 (MLL-Break Apart)

Myeloproliferative Neoplasms (MPN) 4q12 (FIP1L1/CHIC2/PDGFRA) 5q33 (PDGFRB-Break Apart) BCR/ABL (BCR/ABL/ASS) FGFR1-Break Apart

Non-Hodgkinâ&#x20AC;&#x2122;s Lymphoma (NHL) t(8;14) (MYC/IGH)

MALT1-Break Apart c-MYC Break Apart t(11;14) (CCND1/IGH) t(14;18) (IGH/BCL2) IGH-Break Apart

3q27 (BCL6-Break Apart)

BCL2-Break Apart

1p/1q 17p13 (TP53) t(4;14) (FGFR3/IGH) D5S23/D5S71/CEP9/CEP15 t(11;14) (CCND1/IGH) t(14;16) (IGH/MAF) 13q14/13q14

MOLECULAR DIAGNOSTICS MOLECULAR DIAGNOSTIC TESTING SOLID TUMORS NGS Panel Solid Tumors NGS Panel Focus::Oncomine™ (35 genes) Lung, CRC, Breast, Gastro., Brain, Melanoma, Thyroid, Bladder, Kidney

Breast Cancer EGFR Mutation PIK3CA Mutation

Upper Gastrointestinal Cancer BRAF Mutation Lung Cancer CKIT Mutation EGFR Mutation cobas® [FDA-Cleared] - Reflex to PDGFR∝ BRAF Mutation PDGFR∝ HER2 Mutation cMET Gene Expression KRAS Mutation ERCC1 Expression PIK3CA Mutation TS Gene Expression cMET Gene Expression Brain Cancer EGFR Expression EGFRvIII Mutation ERCC1 Expression IDH1 & IDH2 Mutations RRM1 Gene Expression MGMT Methylation TS Gene Expression EML4-ALK (PCR) ROS1(PCR) Colorectal Cancer (CRC) KRAS Mutation NRAS Mutation BRAF Mutation EGFR Mutation by sequencing PIK3CA Mutation UGT1A1 Genotyping cMET Gene Expression EGFR Expression ERCC1 Expression TS Gene Expression VEGFR2 Gene Expression

Melanoma BRAF Mutation cobas® [FDA-Cleared] BRAF Mutation NRAS Mutation KIT Mutation Thyroid Cancer BRAF Mutation KRAS Mutation NRAS Mutation Ovarian Cancer BRAF Mutation PIK3CA Mutation KRAS Mutation

Endometrial Cancer PIK3CA Mutation Kidney Cancer UroGenRA®-Kidney Array-CGH Tissue of Origin® Tissue of Origin® [FDA-Cleared] Tissue of Origin® Endometrial Tissue of Origin® Head & Neck

HEMATOLOGICAL MALIGNANCIES NGS Panels Lymphoma NGS Panels Focus::CLL™ (25 genes) Focus::DLBCL/FL™ (45 genes) Focus::MCL™ (34 genes) Focus::Lymphoma™ (50 genes) Lymphoid Extended ™ (220 genes) Myeloid NGS Panels Focus::AML™ (37 genes) Focus::MDS™ (27 genes) Focus::MPN™ (25 genes) Focus::Myeloid™ (50 genes) Acute Myeloid Leukemia (AML) KIT Mutation (Exon 8 and 17) CEBPA Mutation FLT3 Mutation (ITD, D835) NPM1 Mutation (Exon 12) Chronic Lymphocytic Leukemia/ Small Lymphocytic Lyphoma (CLL/SLL) IGHV Mutation MatBA®-CLL/SLL Array-CGH NOTCH1 Mutation SF3B1 Mutation TP53 Mutation

Lymphoma B-Cell Clonality (IGH) BRAF Mutation(Hairy Cell) MatBA®-DLBCL Array-CGH MatBA®-FL Array-CGH MatBA®-MCL Array-CGH MYD88 L265P Mutation NOTCH1 Mutation TP53 Mutation T-Cell Clonality (TCRβ & TCRy) Non-CMLMyeloproliferative Neoplasms (MPN) CALR Mutation (ET,PMF) KIT (D816) (Mast Cell Disease) JAK2 V617F (PV, ET, PMF) JAK2 V617F, if negative reflex to - Reflex to CALR - Reflex to MPL - Reflex to JAK2 Exon 12 JAK2 Exon 12 (PV) MPL (ET, PMF)

Chronic Myelogenous Leukemia (CML) ABL Kinase Domain Mutation BCR-ABL Quantitative & Qualitative - Major (p210) (IS) - Minor (p190)

SPECIMEN COLLECTION 47

SENDING YOUR SPECIMENS

Specimen Retrieval Kits Supplies and containers for our laboratory services are permitted by State and Federal laws. CGI will provide you, at no charge, with all the supplies you need: requisition forms, tubes, packaging transport forms, etc. Supply requests can be submitted to us by contacting your account manager or by contacting our accessioning department. You can reach the department by phone at (888) 334-4988 or by email specimen@cgix.com.

Sending Your Specimens When you first sign up with CGI, your account representative will help you determine your specific courier needs, which are decided according to your geographical location. Our service runs both day and night, based upon our clients’ schedules, to ensure that our clients are able to continue to operate according to their own established schedule. FedEx is available for all clients outside of our local geographic region. Regardless of the method used, CGI will provide prompt and efficient service to ensure that clients receive results in a timely manner. Our accessioning office can be reached by phone (888) 334-4988, or by email specimen@cancergenetics.com.

Labeling Instructions Based on regulatory requirements, all specimen containers must be labeled with at least two patient identifiers such as, patient name and date of birth. Also, the collection dates and times must be on either the requisition or specimen container. All specimens received in the laboratory must have a completed requisition form with all appropriate information filled out, including: • Patient name • Patient DOB • Collection data/time • Specimen type/site • Requesting physician

SPECIMEN COLLECTION Handling of a Bone Marrow Specimen “Dry Tap” CGI has a very high success rate with limited amounts of marrow as well as with more cellular aspirate specimens. The following specimen collection method can help our hemato-pathologists to reach a conclusive diagnosis on these types of specimens: 1. Collect 2 or more bone marrow core biopsies a. Make 5-10 touch imprint slides from the biopsies (for Cytology and Morphology) • Be sure to keep slides AWAY FROM FORMALIN • Do not place open formalin jar anywhere near slides as the formalin fumes may affect the quality of morphologic evaluation • Let all slides AIR DRY COMPLETELY before placing in the plastic container to prevent smudging b. Place the 1st bone marrow core biopsy in a Formalin jar (for Histology & IHC testing) c. Place the 2nd biopsy in RPMI media (for Flow Cytometry and/or Cytogenetics testing) • Store in refrigerator until shipped d. Additional samples/clot should be submitted for histology

2. Indicate on REQUISITION that the specimen is a “DRY TAP” 3. Collect a peripheral blood specimen in a Sodium Heparin or green top tube (for possible Flow Cytometry and/or FISH testing, if indicated). 4. Collect a peripheral blood specimen in an EDTA or purple top tube (for possible molecular testing, if indicated). 5. Place each specimen in the Biohazard bag before placing in kit. 6. Call 888.334.4988 or +1 201.528.9187 for a specimen pickup or contact your local account representative or client services if you have any questions.

SPECIMEN REQUIREMENTS Hematological Malignancies ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

ALCL FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

ACUTE LYMPHOCYTIC LEUKEMIA (ALL) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Myeloid/Lymphoid/Acute Leukemia Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

BM Transplant Monitoring B-ALL FISH Panel T-ALL FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

ACUTE MYELOID LEUKEMIA (AML) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Myeloid/Lymphoid/Acute Leukemia Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

BM Transplant Monitoring AML FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

KIT Mutation (Exon 8 and 17) CEBPA Mutation FLT3 Mutation (ITD, D835)

1 Lavender/EDTA tube of peripheral blood or bone marrow aspirate (2-3 mL) at room temperature.

NPM1 Mutation (Exon 12) Focus::AML™ (NGS) AML Complete™

1 Green/NaHeparin or 1 Lavender/EDTA tube (5-7 ml) peripheral blood or bone marrow at room temperature or 2-8°C; FFPE tissue block at room temperature.

SPECIMEN REQUIREMENTS

BURKITT LYMPHOMA IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

MYC/IGH DNA-FISH Probe

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

ZAP-70 Flow Panel

1 Green/NaHeparin or Lavender/EDTA tube 2 ml peripheral blood/bone marrow at room temp.

MRD-CLL Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube peripheral blood (10 ml) or bone marrow (3 ml) at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

BM Transplant Monitoring CLL FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

IGHV Mutation NOTCH1 Mutation SF3B1 Mutation

1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or 2-8°C.

TP53 Mutation Focus::CLL™ (NGS)

1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature.

MatBA®-CLL/SLL

1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow aspirate at room temperature or 3-5 FFPE sections at 10 μm thickness on regular slides at room temperature.

CLL Complete™

1 Green/NaHeparin and 1 Lavender/EDTA tube (8-10 ml) peripheral blood or bone marrow at room temperature; FFPE tissue block at room temperature or 0.5 cm3 fresh tissue in RPMI on ice.

SPECIMEN REQUIREMENTS

CHRONIC MYELOGENOUS LEUKEMIA (CML) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Myeloid/Lymphoid/Acute Leukemia Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

BM Transplant Monitoring CML FISH Panel CML in Blast Crisis FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

ABL Kinase Domain BCR/ABL Qualitative BCR/ABL Quantitative Major & Minor

1 Lavender/EDTA tube peripheral blood or bone marrow (3-5 ml) at room temperature or 2-8°C within 48 hours after collection.

DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) IHC Evaluation cMYC, Ki-67 (IHC) GCB vs. Non-GCB Subtyping (IHC)

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Lymphoid Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

NHL FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

B-Cell Clonality (IGH)

1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or 2-8°C or 30-50 μm total FFPE sections at room temperature.

TP53 Mutation

1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or Focus::DLBCL/FL™ (NGS) 2-8°C. MatBA -DLBCL

FFPE: block containing ≥ 70% tumor. Minimum size: 2 mm x 2 mm tumor area, shipped at room temperature. Fresh-Frozen Tissue: 0.2 cm3 minimum (in OCT is acceptable) containing ≥50% tumor. Stored at -80°C /-20°C, shipped on dry ice.

DLBCL Complete™

1 Green/NaHeparin and 1 Lavender/EDTA tube (5-7 ml) peripheral blood or bone marrow aspirate at room temperature; FFPE tissue block at room temperature or 0.5 cm3 fresh tissue in RPMI on ice.

SPECIMEN REQUIREMENTS

FOLLICULAR LYMPHOMA (FL) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Lymphoid Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

NHL FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

Focus::DLBCL/FL™ (NGS)

1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or 2-8°C.

MatBA -FL

FFPE block containing ≥ 70% tumor (Min size: 2 mm2 tumor area) shipped at room temperature or 0.2 cm3 fresh frozen tissue (Min >50% tumor, in OCT is acceptable) stored at -80°C /-20°C and shipped on dry ice.

LYMPHOMA IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Lymphoid Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

NHL FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

B-Cell Clonality (IGH) BRAF Mutation MatBA®-DLBCL MatBA®-FL MatBA®-MCL

1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or 2-8°C or 30-50 μm total FFPE sections at room temperature.

MYD88 L265P Mutation NOTCH1 Mutation T-CellClonality (TCRß & TCRУ) Focus::Lymphoma™ (NGS)

1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or 2-8°C.

SPECIMEN REQUIREMENTS

MALT LYMPHOMA IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Lymphoid Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

NHL FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

MANTLE CELL LYMPHOMA (MCL) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Lymphoid Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

NHL FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

Focus::MCL™ (NGS)

1 Lavender/EDTA tube (2-3 ml) peripheral blood or bone marrow at room temperature or 2-8°C.

MatBA®-MCL

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood or bone marrow at room temperature; FFPE block containing ≥ 60% tumor (Min 2 mm2 tumor area) shipped at room temperature or fresh frozen tissue (Min 0.2 cm3, in OCT is acceptable) containing ≥50% tumor stored at -80°C /-20°C and shipped on dry ice.

MYELODYSPLASTIC SYNDROME (MDS) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

BM Transplant Monitoring MDS FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

Focus::MDS™ (NGS)

1 Lavender/EDTA tube of peripheral blood or bone marrow aspirate (2-3 mL) at room temperature.

MDS Complete™

1 Green/NaHeparin or 1 Lavender/EDTA tube (5-7 ml) peripheral blood or bone marrow at room temperature or 2-8°C; FFPE tissue block at room temperature.

SPECIMEN REQUIREMENTS

MULTIPLE MYELOMA (MM) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

MM Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

MM with PPC FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

MYELOPROLIFERATIVE NEOPLASMS (MPN) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Myeloid/Lymphoid/Acute Leukemia Flow Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

BM Transplant Monitoring MPN FISH Panel

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

CALR Mutation c-KIT Mutation (D816) JAK2 Exon 12 Mutation JAK2 V617F Mutation

1 Lavender/EDTA tube of peripheral blood or bone marrow aspirate (2-3 mL) at room temperature.

MPL 515/505 Mutation Focus::MPN™ (NGS) MPN Complete™

1 Green/NaHeparin and 1 Lavender/EDTA tube (5-7 ml) peripheral blood or bone marrow aspirate at room temperature or 2-8°C; FFPE tissue block at room temperature.

PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

PNH Test (Flow)

1 Green/NaHeparin or 1 Lavender/EDTA tube (2 ml) peripheral blood or bone marrow at room temperature.

Karyotype (G-banding)

1 Green/NaHeparin or 1 Lavender/EDTA tube (3-5 ml) peripheral blood, bone marrow or disaggregated tissue at room temperature.

SPECIMEN REQUIREMENTS Solid Tumors BLADDER CANCER IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

UroVysion®

25-50 ml urine in a suitable container. Same day shipping or PreservCyt® should be used if the specimen will remain in transit for more than a day to ensure stability.

Focus::Oncomine™ (NGS)

BRAIN CANCER PTEN 1p/19q Deletion

Three 4 µm thick unstained sections on positively coated slides or FFPE tissue block at room temperature.

Focus::Oncomine™ (NGS) EGFRvIII Mutation IDH1 & IDH2 Mutations

MGMT Methylation

BREAST CANCER IHC Evaluation HER2 Pathway®

4-5 μm thick FFPE sections on positively coated slides at room temperature.

HER2 INFORM

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

HER2 PathVysion®

Three 4 µm thick unstained sections on positively coated slides or FFPE tissue block at room temperature.

PTEN Focus::Oncomine™ (NGS) EGFR Mutation PIK3CA Mutation Breast Complete™

FFPE block or 5-10 FFPE sections at 10 μm thickness on positively coated slides shipped at room temperature, with H&E slide(s). Please submit 15 sections for small biopsies. The tumor tissue must be ≥ 20% tumor cells for accurate test results. Fifteen 4-5 μm thick FFPE unstained sections on positively coated slides or FFPE tissue block at room temperature.

CERVICAL CANCER

IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

FHACT®

Liquid cytology in PreservCyt or SurePath. Specimens should be sent within 3 weeks after collection. Specimens may be shipped at room temperature (≤ 25˚C). Specimen vol >10 mL.

SPECIMEN REQUIREMENTS

COLORECTAL CANCER (CRC) IHC Evaluation MMR Profile Morphology

4-5 μm thick FFPE sections on positively coated slides at room temperature. FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Focus::Oncomine™ (NGS) KRAS Mutation NRAS Mutation BRAF Mutation EGFR Mutation PIK3CA Mutation UGT1A1 Mutation cMET Gene Expression

EGFR Expression ERCC1 Expression TS Gene Expression VEGFR2 Gene Expression Micro-Satellite Instability

FFPE block or 10 4-5 μm thick FFPE sections on positively coated slides at room temp.

CRC Complete™

FFPE block or 3-5 FFPE sections at 10 μm thickness containing at least 20% of tumor cells on regular unstained slides at room temperature with H&E slides.

GASTRIC CANCER IHC Evaluation

3-5 µm thick FFPE sections on positively coated slides at room temperature.

HER2 Amplification

Three 4 µm thick unstained sections on positively coated slides or FFPE tissue block at room temperature.

Focus::Oncomine™ (NGS) BRAF Mutation CKIT Mutation PDGFR∝ cMET Gene Expression

FFPE Block or 3-5 FFPE sections at 10 μm thickness containing at least 20% of tumor cells on regular unstained slides at room temperature with H&E slides.

ERCC1 Expression TS Gene Expression

KIDNEY CANCER IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

UroGenRA -Kidney

Biopsy: minimum 3-4 needle/core biopsies (18-gauge needle) placed in a cryovial containing saline, transport frozen. (Minimum 70% tumor population). Resected Specimen: minimum of 0.2 cm3 tissue, snap-frozen in a cryovial and transported in frozen condition. (Minimum 70% tumor population).

SPECIMEN REQUIREMENTS MELANOMA IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Focus::Oncomine™ (NGS) BRAF cobas® Mutation BRAF Mutation NRAS Mutation

KIT Mutation

NON-SMALL CELL LUNG CANCER (NSCLC) IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

ALK Break Apart DNAFISH Probe FGFR1 (FISH) MET (FISH)

FFPE block or sections at 3-5 μm thickness on positively coated slides at room temperature.

RET (FISH) ROS1 DNA-FISH Probe cMET Gene Expression EGFR Mutation EGFR cobas® Mutation EML4-ALK RNA Fusion ERCC1 Gene Expression Focus::Oncomine™ (NGS) HER2 Mutation KRAS Mutation

ROS1 RNA Fusion RRM1 Gene Expression TS Gene Expression VEGFR1 Gene Expression Lung Complete™

FFPE tissue block or 3-5 FFPE sections at 10 μm thickness containing at least 20% of tumor cells and 5 FFPE sections at 3-5 μm thickness at room temperature.

SPECIMEN REQUIREMENTS THYROID CANCER IHC Evaluation

4-5 μm thick FFPE sections on positively coated slides at room temperature.

Morphology

FFPE tissue block at room temp. or 0.5 cm3 fresh tissue in RPMI on dry ice.

Focus::Oncomine™ (NGS) BRAF Mutation KRAS Mutation

NRAS Mutation

TISSUE OF ORIGIN® Tissue of Origin® [FDA-Cleared] Tissue of Origin® Endometrial Tissue of Origin® Head & Neck

FFPE block containing at least 1 mm2 of tumor tissue by area and an H&E stained slide if possible. Unstained slides of at least 5 μm thickness (10 μm thickness preferred) that contain no less than 1 mm2 of tumor tissue.

BILLING

BILLING POLICIES

Billing Policy Our primary focus is to ensure excellence in the personalization of cancer treatment by simplifying and providing visibility into our billing processes. Occasionally, CGI may request necessary adjustments within the guidelines of the law. However, it is in direct conflict with CMS and BIPA guidelines to avoid attempts at collecting reimbursement or to routinely waive copays and deductibles. Our policy is to ensure that non-government and non-contracted payors pay at reasonable commercial rates. As part of this effort, we certify that our billing is compliant with the U.S. Code and National Standards and agree to the following: 1. Accept the amount reimbursed by your patientsâ&#x20AC;&#x2122; insurance. 2. Bill clients according to the Explanation of Benefits (EOB) provided by the patientâ&#x20AC;&#x2122;s insurance carrier. 3. If CGI is instructed by the health plan to bill for co-pays and deductibles, then we are required by law to adhere to such instructions. 4. To never issue a balance bill to you or your patients. 5. Your patients will only be responsible for meeting their co-pays and deductibles as assigned.

We are required to demonstrate to the Centers for Medicare and Medicaid Service (CMS) that we make an effort to collect at or above the Medicare rates. When billing a third party insurance, our practices are: 1. To make a minimum of three attempts to collect from the payor. 2. To notify the patient, if CGI is unable to collect from the payor. 3. To make every effort to become a participating provider for a carrier that has been identified as a non-contracted carrier, but through our analysis is determined to be an ongoing provider.

CPT CODES Cytogenetics FLUORESCENCE IN SITU HYBRIDIZATION (FISH) CODE

PROCEDURE

88271

DNA probe each

88275

Analysis 100-300 interphase cells

88291

Interpretation and report

CHROMOSOMAL G-BANDING CODE

PROCEDURE

88237

Tissue Culture

88262

Analyze 15-20 cells, 2 karyotypes, w/ banding

88280

Additional karyotypes, each study

88291

Interpretation & Report

UROVYSIONÂ® CODE

PROCEDURE

88120

Cytopathology in situ hybridization, urinary tract specimen with morphometric analysis, 3-5 probes, manual

88121

Using computer assisted technology

Cytology CODE

PROCEDURE

88173

Cyto FNA, Interpretation

88104

Cyto Non-Gyn Smears

88112

ThinPrep, Non-Gyn Fluids

88108

CytoSpin, Non-Gyn Conc Tech

88162

Extensive study (6 or more slides)

88305

Cell Block

88312

Special Stain, Group 1 (microorganisms)

88313

Special Stain, Group 2

88342

IHC, each Antibody

88360

IHC Quant, each Antibody

85097

Bone Marrow Smear Interpretation

85060

Peripheral Blood Smear Interpretation

CPT CODES Flow Cytometry CODE

PROCEDURE

88184

Individual Antibodies, First Antibody

88185

Individual Antibodies, Each Additional Antibody

88187

Flow interpretation, 2-8 markers

88188

Flow interpretation, 9-15 markers

88189

Flow interpretation, 16 or more markers

Histology

CODE

PROCEDURE

88302

Surgical Lev 2, Gross & Micro

88304

Surgical Lev 3, Gross & Micro

88305

Surgical Lev 4, Gross & Micro

88307

Surgical Lev 5, Gross & Micro

88309

Surgical Lev 6, Gross & Micro

88311

Decal

88312

Special Stain, Group 1 (microorganisms)

88313

Special Stain, Group 2

88314

Special Stain on Frozen Section

88329

Path Consult During Surgery

88321

Consult

88331

Frozen Section, first block

88332

Frozen Section, additional tissue block

88333

Touch prep Introperative Cyto Exam

88334

Touch prep Introperative Cyto Exam Additional

88342

IHC, each Antibody

88360

IHC Quant, each Antibody

88365

Tissue ISH, each probe

CPT CODES MOLECULAR ACUTE MYELOID LEUKEMIA (AML) CODE

MOLECULAR TEST

81272

c-KIT Mutation Analysis (Exon 8 and 17)

81218

CEBPA Mutation Analysis

81245

FLT3 Mutation Analysis

81310

NPM1 Mutation Analysis

81455

Focus::AML™ (NGS)

BLADDER CANCER CODE

MOLECULAR TEST

81445

Focus::Oncomine™ (NGS)

BRAIN CANCER CODE

MOLECULAR TEST

81445

Focus::Oncomine™ (NGS)

81403

EGFRvIII Mutation Analysis

81403 x2

IDH1 & IDH2 Mutation Analysis

81287

MGMT Promotoer Methylation

BREAST CANCER CODE

MOLECULAR TEST

81445

Focus::Oncomine™ (NGS)

CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) CODE

MOLECULAR TEST

81263

IGHV Mutation Analysis

81479

NOTCH1 Mutation Analysis

81479

SF3B1 Mutation Analysis

81405

TP53 Mutation Analysis

81450

Focus::CLLTM (NGS)

81479

MatBA®-CLL/SLL Array-CGH

CPT CODES

CHRONIC MYELOGENOUS LEUKEMIA (CML) CODE

MOLECULAR TEST

81170

ABL Kinase Domain Mutation Analysis

81206; 81207

BCR/ABL Qualitative

81206; 81207

BCR/ABL Quantitative Major & Minor

COLORECTAL CANCER (CRC) CODE

MOLECULAR TEST

81445

Focus::Oncomine™ (NGS)

81275, 81276

KRAS Mutation Analysis

81311

NRAS Mutation Analysis

81210

BRAF Mutation Analysis

81235

EGFR Mutation Analysis

81404

PIK3CA Mutation Analysis

81350

UGT1A1 Mutation Analysis

81479

cMET Gene Expression

81235

EGFR Expression

81479

ERCC1 Gene Expression

81401

TS Gene Expression

81479

VEGFR2 Gene Expression

DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) CODE

MOLECULAR TEST

81450

Focus::DLBCL/FL

81261

B-Cell Clonality (IGH)

81479

MatBA®-DLBCL Array-CGH

81405

TP53 Mutation Analysis

FOLLICULAR LYMPHOMA (FL)

CODE

MOLECULAR TEST

81450

Focus::DLBCL/FL

81479

MatBA®-FL Array-CGH

CPT CODES

GASTRIC CANCER CODE

MOLECULAR TEST

81445

Focus::Oncomine™ (NGS)

81210

BRAF Mutation Analysis

81272

CKIT Mutation

81314

PDGFR∝

81479

cMET Gene Expression

81479

ERCC1 Gene Expression

81401

TS Gene Expression

KIDNEY CANCER CODE

MOLECULAR TEST

81479

UroGenRA®-Kidney Array-CGH

LYMPHOMA CODE

MOLECULAR TEST

81261

B-Cell Clonality (IGH)

81455

Focus::Lymphoma™ (NGS)

81479

MYD88 Mutation Analysis

81340

T-Cell Clonality (TCRß)

81342

T-Cell Clonality (TCRУ)

MANTLE CELL LYMPHOMA (MCL) CODE

MOLECULAR TEST

81479

MatBA®-MCL Array-CGH

MELANOMA CODE

MOLECULAR TEST

81445

Focus::Oncomine™ (NGS)

81210; 88381

BRAF Cobas® Mutation Analysis

81210

BRAF Mutation Analysis

81311

NRAS Mutation Analysis

81272

KIT Mutation

CPT CODES

MYELODYSPLASTIC SYNDROME (MDS) CODE

MOLECULAR TEST

81455

Focus::MDS™ (NGS)

MYELOPROLIFERATIVE NEOPLASMS (MPN) CODE

MOLECULAR TEST

81273

c-KIT Mutation Analysis (D816)

81219

CALR Mutation Analysis

81455

Focus::MPN™ (NGS)

81403

JAK2 Exon 12 Mutation Analysis

81270

JAK2 V617F Mutation Analysis

81403

MPL 515/505 Mutation Analysis

MYELOPROLIFERATIVE NEOPLASMS (MPN) CODE

MOLECULAR TEST

81273

c-KIT Mutation Analysis (D816)

81219

CALR Mutation Analysis

81455

Focus::MPN™ (NGS)

81403

JAK2 Exon 12 Mutation Analysis

81270

JAK2 V617F Mutation Analysis

81403

MPL 515/505 Mutation Analysis

NON-SMALL CELL LUNG CANCER (NSCLC)

CODE

MOLECULAR TEST

81479

cMET Gene Expression

81235

EGFR Mutation Analysis

81235

EGFR Cobas® Mutation Analysis

81401

EML4-ALK RNA Fusion

81479

ERCC1 Gene Expression

81445

Focus::Oncomine™ (NGS)

81479

HER2 Mutation Analysis

81275

KRAS Mutation Analysis

81479

ROS1 RNA Fusion

81479

RRM1 Gene Expression

81401

TS Gene Expression

81479

VEGFR2 Gene Expression

CPT CODES

THYROID CANCER CODE

MOLECULAR TEST

81445

Focus::Oncomine™ (NGS)

81210

BRAF Mutation Analysis

81275

KRAS Mutation Analysis

81311

NRAS Mutation Analysis

TISSUE OF ORIGIN® CODE

MOLECULAR TEST

81504

Tissue of Origin® [FDA-Cleared]

81504

Tissue of Origin® Endometrial

81504

Tissue of Origin® Head & Neck

LICENSURE & COMPLIANCE

Quality Control Program CGI is committed to providing reliable and accurate diagnostic services to our clients. Patient safety, in the form of accurate specimen identification, timely communication of life-altering diagnoses is paramount in everything we do. We monitor and improve our performance through a variety of methods, including performance improvement indicators, proficiency testing, external audits, and satisfaction surveys. All quality concerns and incidents are subject to root cause analysis, and our procedures are all put through periodic evaluation via the Plan-Do-Check-Act model of continuous improvement, to ensure that we are providing the best services possible to our patients and clients. Protection of patient results from misuse or poor access is imperative and thus electronic and paper results are strictly guarded via password-protection and ID cards according to HIPAA guidelines. CGIâ&#x20AC;&#x2122;s laboratory is GCP and HIPAA compliant, CLIAcertified, CAP-accredited, and holds licensure in several US States including New York State. Our commitment to quality extends to our employees as we have a comprehensive safety program to ensure the health and well-being of everyone at CGI.

Licenses and Credentials CGI and CGI Laboratories are fully approved, accredited and licensed by CLIA, CAP, Medicare/Medicaid and states of California, Florida, Maryland, New Jersey, New York, and Pennsylvania. Our operations extend throughout the East Coast and include multiple states in New England, Mid-Atlantic and the South. The laboratory operations adhere to HIPAA guidelines and policies.

RUTHERFORD, NJ CAP Accreditation

Lab Number: 7191582, AU-ID: 1434060

CLIA Certificate

Certificate Number: 31D1038733

California License

COS 00800558

Florida License

800018142

Maryland License

1395

New Jersey License

CLIS ID: 0002299

Pennsylvania License

031978

New York License

PFI: 8192

LOS ANGELES, CA CAP Accreditation

Lab Number, LAP#: 7209131

CLIA Certificate

Certificate Number: 05D1066073

California License

CLF00335062

Florida License

800024084

Maryland License

1471

New York License

PFI8384

Pennsylvania License

030842

Rhode Island License

LC00525

RALEIGH, NC CAP Accreditation Biorepository

Lab Number: 8033768, AU-ID: 1636028

CLIA Certificate

Certificate Number: 34D1009209

21 CFR 58 compliant GLP 21 CFR 11 compliant (Electronic Signatures) ISBER Best Practices

SHANGHAI, CHINA Meets or exceeds all local regulatory compliance expectations and is both CLIA and CAP compliant.

Licenses can be printed directly from the Clinical Testing tab on our website at: www.cancergenetics.com/clinicaltrials/regulatory-licensing

LICENSURE & COMPLIANCE

Confidentiality Permitted Uses and Disclosures of Protected Health Information (PHI) CGI policy requires that the identity of anyone who requests access to Protected Health Information (PHI) will be verified before any disclosure of PHI is made. CGI will make reasonable efforts to use or disclose only the “minimum amount of confidential information necessary” in all circumstances. Exceptions to the minimum necessary rule are: • PHI requested for treatment purposes • PHI provided to the patient or authorized by the patient, and/or • PHI requested as required by law for HIPAA compliance

CGI will document and retain the signed authorization in the patient’s folder. Patient will be provided with a copy of the same. Patients have the right to revoke authorizations for release of records. The revocation should be in writing via a letter to CGI. The revocation will not affect any actions already taken by CGI based upon the original authorization.

Physical Safeguards of PHI It is the policy of CGI that physical safeguards will be in place to reasonably ensure that PHI will not intentionally or unintentionally be disclosed in violation of the HIPAA regulation. These safeguards include physical and administrative protection of the PHI. This protection will also be extended to oral communication of PHI.

Authorized Uses and Disclosures of Protected Health Information (PHI) According to HIPAA regulation, CGI must obtain the individual’s written authorization for any use or disclosure of PHI that is not for treatment, payment, health care operations or other functions listed above as permitted uses and disclosures. An authorization must be written in plain language and contain specific information regarding the information to be disclosed or used, the person(s) disclosing and receiving the information, expiration, right to revoke in writing, signature of patient and date. In compliance with state law and regulation,

LICENSURE & COMPLIANCE Compliance Statement It is CGI’s goal to meet or exceed all guidelines and regulations set forth for the operation of a clinical and research laboratory. As such, current and future policies and procedures must be created within the guidelines of all appropriate regulatory agencies. 1. It is CGI’s policy to adhere to current CAP Terms of Accreditation, as well as all applicable federal, state, and local regulations. 2. Each Section Supervisor is responsible for periodically reviewing regulations relevant to his/her discipline for each state in which CGI offers testing. Any regulatory changes should be discussed in order to determine appropriate action by the laboratory. 3. The laboratory will abide by the privacy and information protection regulations set forth by the HIPAA. 4. The laboratory directors will notify CAP whenever the laboratory is investigated by a state or federal agency or for adverse media attention related to the laboratory performance. Notification must occur no later than 2 working days after the laboratory learns of an investigation or adverse media attention. 5. The laboratory directors will notify CAP when there is a change in the laboratory’s test menu. Notification must occur prior to starting new patient testing.

6. The laboratory directors will notify CAP of changes in location, ownership or directorship of the laboratory. Notification must occur prior to the change(s); or, in the case of unexpected changes, no later than 2 working days afterwards. 7. The lab participates in all relevant CAP surveys and the New York State proficiency testing program. 8. CAP checklists will be reviewed annually. A SelfEvaluation will be conducted in the interim year between CAP inspections, and a completed Verification Form will be submitted to CAP. 9. The laboratory director will notify all states in which it offers testing and CAP in the event that the laboratory should cease operation, and where records will be available in accordance with the Record Retention & Disposal Policy.

REPORTING 75

REPORTING

CGI Reports We offer our clients standard methods of communication such as email or fax to HIPAA compliant machines, as well as through the U.S. postal service. Alternatively, we offer HIPAA compliant, web-based report system through which reports can be accessed at anytime and anywhere. We maintain extended office hours so that a qualified member of our staff is always available to send the information to you when you need it.

My CGI Reports & RDxPortal: Access Patient Reports Instantly This service offers clients access to their own patients’ reports through our interactive website. Each client is given an individual username and password that allows them to gain access to their patients’ reports and communicate with our client services staff. This webbased, secure structure puts all of your patients’ reports right at your fingertips. Clients have the capability to access and view reports from the office, at home, or on the go. All patient reports are generated by our pathologists and can be viewed by logging in at https:// cgireports.com or https://portal.responsegenetics.com/ portal/home. Please call our office at 201.528.9187 to be set up with an account to access your patients’ reports.

Patient Name: Sex: Date of Birth: Specimen: Collected: Received: Reported: Clinical Hx:

Male

Accession Number: CGI ID No: Ordering Physician: Client: Client Account No: Client Address:

Female

Telephone:

FLOW CYTOMETRY REPORT Interpretation:

A monoclonal population of sLambda+, CD19+, CD20+, CD5+, CD10-, CD23+, CD11c+ B cells detected, 98% of lymphocytes, 95% of total cells, consistent with B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma, CD38-, ZAP70- (see comment).

Comments:

ZAP70+ B-cells comprise 6% of CLL cells, with the B-cell to T-cell mean fluorescence intensity ratio of 0.35. Correlation with IGHV mutation status is recommended. Cutoff for ZAP70 expression (% of CLL cells): ZAP70 Positive: >30% ZAP70 Borderline: 20-30% ZAP70 Negative: <20%

Results:

Viability (7-AAD): 74% Differential Cell Count :

Lymphocytes Monocytes Granulocytes BLASTS Plasma Cells Abnormal cell population: Present Abnormal cell size: Small T/NK antigens (lymphocyte gate) CD3 CD7 CD5 CD2 CD3+CD4 CD3+CD8 CD56+CD3CD57

1% 1% 1% 1% 1% 0.2% 0.2% 0.2%

B-cell antigens (lymphocyte gate) CD19 CD20 CD19+sKappa CD19+sLambda CD19+CD5 CD20+CD10 CD19+CD11c CD19+CD38 CD19+CD23 ZAP70 (CLL)

96 % 1% 2% 0% 0%

98% 97% 0.5% 98% 98% 0.1% 33% 0.1% 80% 6%

CD19 vs CD5

Myeloid/Other antigens (open gate) CD45 CD38 Bright

100% 0.01%

Electronically signed by: Date: End of Report

The tests utilizing analyte-specific reagents (ASR) were developed and their performance characteristics determined by Cancer Genetics, Inc. as required by CLIA '88 regulations. They have not been cleared or approved for specific uses by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. These tests are used for clinical purposes. Cancer Genetics, Inc., 201 Route 17 North, Rutherford, NJ 07070. Phone number: (888) 334 - 4988 CLIA#:31D1038733; CAP LAP#: 7191582 Lan Wang, MD, Medical Director

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Summation™ Report

Summation™ is a CGI-developed comprehensive one page, one view color diagnostic summary report. By choosing Summation™, our hematopathologists will work up a patient’s case based on the clinical information and diagnosis provided. Our Summation™ report integrates IHC, flow cytometry, cytogenetics, FISH and molecular genetic test results into a concise and clinically relevant summary that: • Provides comprehensive diagnostic information • Utilizes user-friendly and easy to interpret format • Offers appropriate patient management information The integration of all CGI’s testing technologies into a Summation™ report drives quick decisions by enabling clinicians/physicians to efficiently arrive at a definitive diagnosis. Our integrative Complete™ Programs are reported as a Summation™ report.

Patient Name: Sex: Date of Birth: Specimen: Collected: Received: Reported:

Male

Female

Accession Number: CGI ID No: Ordering Physician: Client: Client Account No: Client ID No: Client Address: Telephone:

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Σ Summation Report

CLINICAL DATA: Lymphoproliferative Disorders: CLL/SLL, Relapse, Tx: Rituxan. No CBC information provided. FINAL DIAGNOSIS:

A monoclonal population of sLambda dim+, CD19+, CD20 dim+, CD5+, CD10-, CD23+, CD11c- cells detected by flow cytometry analysis, 75% of lymphocytes, 46% of total cells, consistent with B-cell chronic lymphocytic leukemia, CD38+, ZAP70 borderline+, with a productive mutated IGH V3-21 rearrangement. Abnormal karyotype 46,XY,add(14)(p12),add(17)(q25)[16]/ 46,idem,add(21)(q22)[4] Positive for gain of 8q24.21 and deletion of 13q14 by MatBA analysis. Positive for two pathogenic mutations in ATM gene, and a mutation of uncertain significance in CARD11 gene by NGS-CLL panel analysis. COMMENTS: Usage of IGH V3-21 rearrangement, gain of 8q24.21, complex abnormal karyotype, and ATM mutations are associated with unfavorable prognosis in CLL. Clinical correlation and follow up is recommended.

Flow plot of CD19 vs CD5

FLOW CYTOMETRY: A monoclonal population of sLambda dim+, CD19+, CD20 dim+, CD5+, CD10-, CD23+, CD11c- cells detected, 75% of lymphocytes, 46% of total cells, consistent with B-cell chronic lymphocytic leukemia, CD38+, ZAP70 borderline+. KARYOTYPE: 46,XY,add(14)(p12),add(17)(q25)[16]/46,idem,add(21)(q22)[4] Abnormal Karyotype

CEP12(2 green)/ 13q14(1 red)/ 13q34(2 aqua)

FISH: Abnormal CLL FISH Panel Results with heterozygous deletion of 13q14 (loss of one D13S319 signal) in 68% cells. MOLECULAR: IGHV Mutation Status: Detected a productive Mutated IGHV3-21 rearrangement. Usage of V3-21 is associated with adverse prognosis in CLL independent of IGHV mutation status IGHV Family: V3-21 Functionality: Productive Mutation Frequency: 2.8%

46,XY,add(14)(p12),add(17)(q25) The tests utilizing analyte-specific reagents (ASR) were developed and their performance characteristics determined by Cancer Genetics, Inc. as required by CLIA '88 regulations. They have not been cleared or approved for specific uses by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. These tests are used for clinical purposes. Cancer Genetics, Inc., 201 Route 17 North, Rutherford, NJ 07070. Phone number: (888) 334 - 4988 CLIA#:31D1038733; CAP LAP#: 7191582 Lan Wang, MD, Medical Director

Σ 15-000000

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REQUISITION FORMS

Ordering Requisition Forms Requisition forms are available as fillable PDFs or in traditional hardcopy form. Fillable PDF versions can be downloaded from our website by clicking the â&#x20AC;&#x153;ORDER A TESTâ&#x20AC;? button up in the header or by entering the following URL: http://www.cancergenetics.com/laboratory-services/ order-a-test/ To order hard-copy requisition forms, or for any other questions regarding specimen requirements, shipping instructions, or logistics, please contact our client services team. Client Services: email: ClientServices-NJ@cgix.com phone: +1 201.528.9187 fax: +1 201.933.0787