– Simultaneously Assesses 27 Unique Immune Markers
– Determines Optimal IO Therapies and Tracks Response and Resistance Mechanisms
RUTHERFORD, N.J., Jan. 17, 2018 (GLOBE NEWSWIRE) — Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, today announced the expansion of its immuno-oncology (IO) panel, Complete::IO™, to include five new IO markers. This brings the total number of markers it simultaneously detects to 27, making Complete::IO™ the most comprehensive flow-cytometry-based biomarker panel in the industry, with a 24-hour turn around time.
Since its launch in April 2017, Complete::IO has quickly gained commercial traction and has already been included in notable immunotherapy trials including studies of CAR-T therapies and checkpoint inhibitors. Complete::IO™ is a multi-marker panel enabling comprehensive characterization of the immune repertoire of cancer patients, including circulating immune cell populations and the tumor microenvironment. It plays a unique role in identifying ideal patient populations for specific IO therapies and addresses the unmet need to monitor and stratify patient populations during clinical trials. The panel also assures that patients are monitored for safety and toxicity throughout the trial. The increased number of markers allows for the identification of rare and challenging subsets of immune cells.
Besides the commonly studied subsets, central memory, effector, effector memory cells, naïve CD4+ and CD8+ T cells, T-regs, B-regs, NK, and plasmacytoid dendritic cells, Complete::IO™ is now able to power highly accurate immunophenotyping and the measurement of the frequency of myeloid-derived suppressor cells (MDSCs), as well as those that express PD-1, PD-L1, or PD-L2.
The presence and frequency of MDSCs, which inhibit anti-tumor immune response, in the blood of cancer patients, might represent a novel and accessible biomarker to monitor clinical outcome and response to therapy. In addition, targeting MDSCs to increase the efficacy of immunotherapeutics appears to be a clinically promising strategy, and is being actively evaluated in clinical trials. According to industry reports, there are over 2,500 active clinical trials globally related to IO therapies.
“Complete::IO™ analyzes dynamic changes across immune cell populations, and with this latest expansion, includes additional biomarkers that have emerged as important to immuno-oncology,” said Rita Shaknovich, Chief Medical Officer of CGI. “Complete::IO has the unique ability to determine precise details of anti-tumor immunity for each patient. Complete::IO™ effectively enables informed therapeutic decisions and assessment of potential toxicities of IO therapies in both hematological malignancies and solid tumors.”
The addition of PD-1, PD-L1 and PD-L2 to the panel is in concert with recent studies associating the expression of these markers by tumor cells and/or immune cells in the tumor microenvironment with clinical efficacy of IO therapies. Flow cytometry as compared to other methods has the advantage of simultaneously measuring the expression of PD-1 and its ligands PD-L1 and PD-L2 in malignant cells and various types of immune cells. This provides a more comprehensive understanding of PD-1/ligand interactions between tumor cells and the immune environment.
“Cancer therapy has been revolutionized by the development of IO therapies, including checkpoint inhibitors and others. However, response rates are variable and the development of more robust assays is imperative. To our knowledge, Complete::IO™ is one of the most comprehensive solutions for drug companies and physicians seeking to optimize their novel treatment options, including mono- and combination therapies” said Panna Sharma, CEO and President of CGI. “The pharmaceutical industry has already recognized the merits of applying this solution to biomarker studies as part of the clinical development of novel cancer therapies, both as a valuable tool for patient selection and for monitoring. We expect it to become an integral component of additional IO studies to help patients gain maximum benefit from immunotherapy options in the treatment of cancer. The expansion of our Complete::IO™ panel is key to our continued strategy to move beyond genomics to integrate information about immune marker status, the tumor microenvironment and cell surface biomarker expression in order to predict patient responses.”
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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to Cancer Genetics’ strategic focus and the future development, commercialization and outcomes associated with its tests and testing services.
Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, risks of cancellation of customer contracts or discontinuance of trials, risks that anticipated benefits from acquisitions will not be realized, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Cancer Genetics, Inc. Form 10-K for the year ended December 31, 2016 and the Form 10-Q for the Quarter ended September 30, 2017 along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics, Inc. disclaims any obligation to update these forward-looking statements.
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