Cancer Genetics, Inc. Industry Panel analyzes dynamic changes across immune cells.

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Original Press Release:

Cancer Genetics, Inc. Launches a Unique, Industry-Leading Panel that Provides Comprehensive & Precise Information for Immuno-Oncology Therapy Assessment & Patient Monitoring

• Complete::IO™ provides immune endpoint and immune monitoring of patients allowing informed therapeutic decisions and assessment of potential toxicities of IO therapies in blood cancers and solid tumors
• Complete::IO™ can determine precise details of anti-tumor immunity for each cancer patient as it allows the detection of multiple markers on an individual cell, which is limited when utilizing other technology platforms, including next-generation sequencing (NGS) and immunohistochemistry (IHC)

Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or “The Company”), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, announced today the successful CLIA validation and approval of its immuno-oncology (IO) assay, Complete::IO™. Complete::IO™ is a multi-marker, flow cytometry-based panel allowing a comprehensive characterization of the immune repertoire of cancer patients, including circulating immune cell populations and the tumor microenvironment. As IO drugs become more commonplace both as mono- and combination therapies, improved and more comprehensive technology is required to monitor and stratify patient populations during clinical trials. Complete::IO™ was designed to meet this need, and is based on the simultaneous detection of up to 10 markers on each cell, allowing identification of rare and challenging subsets of immune cells.

"With the extremely high promise of IO therapies and CGI's track record in innovative and proprietary assay development and application, we believe that Complete::IO™ will become a key tool in selecting patients, monitoring response, and predicting toxicities in IO therapies. Complete::IO™ is already being utilized in the clinical setting for both hematologic malignancies and solid tumors, and is being implemented by our biopharma partners for clinical trials in such indications as glioblastoma," said Daniel Duncan, MD, Medical Director at CGI.

Immune-modulating agents have been around for decades, but for limited use and with limited success. Newly understood immuno-oncology pathways along with more targeted IO drugs have demonstrated significant advances against a wider range of cancers. Complete::IO™ is able to help address the tremendous demand of clinical trials and routine patient care to better monitor changes, responses and potential toxicities by providing comprehensive assessment of anti-tumor immune response. CGI expects Complete::IO™ to be utilized to improve the great potential of IO drugs and become a key tool in addressing the inherent complications of assessing response and dose scheduling in immunotherapy treatments.

Currently, IO is a highly promising area of medicine and has already seen several blockbuster therapies enter the market in disease areas such as non-small cell lung cancer (NSCLC) and melanoma. Wall Street analysts are projecting over $35 billion in annual worldwide sales for immuno-oncology drugs by 2024, which could account for half of all spending on cancer drugs, according to market research firm IMS Health. Pharmaceutical analysts expect that the major biotech and pharmaceutical companies are all expected to spend nearly $1 billion a year on immuno-oncology research, early access, and development programs and clinical trials.

Complete::IO™ is built on CGI's previous experience in developing high-performance biomarker panels designed for various cancer indications, and offers optimized reagent combinations to minimize cost and unwanted technical bias. The panel analyzes dynamic changes across comprehensive immune cell populations. Besides the commonly studied subsets, Complete::IO™ is able to provide highly accurate immunophenotyping of central memory, effector, effector memory, naïve CD4+ and CD8+ T cells, T-regs, B-regs, NK, and plasmacytoid dendritic cells. Complete::IO™ allows the query of both circulating cell populations and tumor microenvironment as it can be performed on fresh tumor biopsies. The workflow has been specifically designed to maximize information yield from smaller samples. Complete::IO™ offers streamlined specimen setup and reporting for turnaround times as short as 24 hours.

"With the rise of targeted immunotherapies, CGI is committed to staying at the forefront of developing tests that are needed to advance immuno-oncology and precision therapy. Complete::IO™ can become an integral component of immuno-oncology patient monitoring for cancer centers and hospitals nationally. Additionally it can be a valuable tool for patient selection and stratification, as well as monitoring therapy effectiveness for our biopharma customers. We fully expect to continue developing the panel as it uniquely offers complex and comprehensive assessment of the patient immune response within one day of receiving the sample," said Panna Sharma, CEO and President of CGI.

ABOUT CANCER GENETICS

Cancer Genetics Inc. is a leader in enabling precision medicine in oncology from bench to bedside through the use of oncology biomarkers and molecular testing. CGI is developing a global footprint with locations in the US, India and China. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of Medicine at USC and the National Cancer Institute.

The Company offers a comprehensive range of laboratory services that provide critical genomic and biomarker information. Its state-of-the-art reference labs are CLIA-certified and CAP-accredited in the US and have licensure from several states including New York State.

For more information, please visit or follow CGI at: Internet: www.cancergenetics.com

Contact:

Panna Sharma

Cancer Genetics, Inc.

Tel: 201-528-9200

Email: panna.sharma@cgix.com