Cancer Genetics, Inc. Expands Its Immuno-Oncology Franchise With The Addition of The FDA-Approved Ventana PD-L1 (sp142) Assay As A Complementary Diagnostic Test For TECENTRIQ™

Published on: Wednesday, June 29th, 2016 View all Media

Rutherford, N.J., June 29, 2016 – Cancer Genetics, Inc. (Nasdaq: CGIX; “CGI” or “The Company”), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, today announced that it offers the FDA-approved VENTANA PD-L1 (SP142) assay as a complementary diagnostic IHC test for TECENTRIQ™, for treatment of urothelial carcinoma patients and is a site for PD-L1 (SP142) testing.

Genentech’s TECENTRIQ™(atezolizumab) is the first cancer immunotherapy drug indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma. This cancer is the most common type of bladder cancer (over 90%) and encompasses cancers of the ureters, urethra, and renal pelvis. The NCI estimates that there will be 77,000 new cases of bladder cancer in 2016 with 16,390 deaths in the US [1].

Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody, which received Breakthrough Therapy Designation by the FDA in May 2014 for the treatment of patients whose metastatic bladder cancer expresses the protein PD-L1. Atezolizumab is also being studied in various other cancers, notably triple-negative breast cancer and PD-L1-positive non-small cell lung cancer (NSCLC).

Analysts estimate that TECENTRIQ™ will top $2.5 billion a year in sales by 2020, and much higher with additional approvals in other indications.

“This is a breakthrough in the revolutionary era of precision therapy. The ability to determine the patient’s level of PD-L1 expression is critical to providing novel therapy options in a targeted and cost-effective manner,” said CGI president and CEO, Panna Sharma. “We are excited to be one of very few labs in U.S. performing this test as we continue to add to our capabilities in immuno-oncology.”

By adding the VENTANA PD-L1 (SP142) assay to its test menu, CGI now offers all the companion and complementary PD-L1 diagnostic tests available on the market for delivering on immuno-oncology therapeutic selection.

According to Peter Keeling, CEO of Diaceutics, a global advisor to pharmaceutical and biotech companies on commercialization strategy, “Our own data and analysis on PD-L1 markers suggests that PD-L1 is well on its way to being one of the most hyper connected biomarkers in key cancer indications like NSCLC, and that Roche’s PD-L1 testing kits and antibodies will likely dominate the global testing market. CGI has demonstrated yet again that it is at the forefront of enabling precision treatment choices in this field.”

[1] SEER Stat Fact Sheets: Bladder Cancer. Surveillance, Epidemiology, and End Results Program, National Cancer Institute. http://seer.cancer.gov/statfacts. (Accessed on 6-15-2016)


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
Twitter: @Cancer_Genetics
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Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to Cancer Genetics Inc.’s expectations regarding the completion, timing, pricing and size of the offering described in this press release constitute forward-looking statements.

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, 2015 and the Form 10-Q for the Quarter ended March 31, 2016 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.