Cancer Genetics, Inc. Listed by Merck as a National Reference Laboratory for KEYTRUDA® (pembrolizumab) Companion Diagnostic Testing

  • Reinforces CGI’s Position as a Leader in Immuno-Oncology & Companion Diagnostics For PD-L1 Testing & Monitoring
  • Company Expects Significant Growth in Comprehensive Molecular & Immune Profiling for Lung Cancer as KEYTRUDA Enters First-Line Treatment

RUTHERFORD, N.J. & LOS ANGELES, Dec. 05, 2016 (GLOBE NEWSWIRE) — Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in enabling precision medicine for oncology through the use of molecular markers and information, announced today that it is on Merck’s list of national reference laboratories offering the PD-L1 22C3 pharmDx immunohistochemistry (IHC) assay, the first U.S. Food and Drug Administration (FDA)-approved companion diagnostic test for pembrolizumab, KEYTRUDA®, for PD-L1 testing in non-small cell lung cancer (NSCLC). The company first started offering the DAKO PD-L1 IHC 22C3 pharmDx test in early 2016, and was recently listed as a national reference laboratory.

In October, the FDA approved pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test, becoming the first FDA approval of a checkpoint inhibitor for first-line treatment of lung cancer. The approval also expanded the indication in second-line treatment of lung cancer to include all patients with PD-L1-expressing NSCLC. The approval was based on results of two randomized, controlled trials that demonstrated statistically significant improvements in survival for patients randomized to pembrolizumab compared with chemotherapy.

Cancer Genetics now offers all the available FDA approved companion diagnostics for PD-L1 testing across several cancer indications, and is providing these tests for both patient management in the clinical setting as well as for immuno-oncology trials sponsored by leading pharmaceutical companies. Cancer Genetics is now supporting over 100 clinical studies and trials, and over 30 with a component for immuno-oncology testing and monitoring.

Dr. Jorge Nieva, Associate Professor of Clinical Medicine at Keck School of Medicine of USC and a global thought leader in developing multidisciplinary lung cancer programs stated, “PD-L1 testing is critically important for my lung cancer patients. Having a high-quality provider that understands the intricacies of PD-L1 scoring and getting those results in a rapid timeframe means that patients don’t have to wait. Consistent, high-quality molecular testing results translate into improved outcomes, reduced waiting times for patients, and a real change in personalizing therapy.”

Clinical awareness of validated biomarker testing and education of clinicians and pathologists about the guidelines for PD-L1, including 22C3, is critical to making breakthrough therapies like KEYTRUDA® more available for patients. Merck and CGI will both carry out activities to educate the clinical marketplace about the utility of PD-L1 IHC 22C3, one of the most important diagnostic markers for such novel immuno-oncology therapies. CGI believes that these educational and awareness activities targeted at clinicians and cancer care facilities will drive higher volume of compliant PD-L1 testing along with an increased demand for comprehensive lung cancer profiling using CGI’s tests and technologies.

CGI and leading cancer experts believe that the synergistic effect of integrating immuno-oncology and targeted therapies will result in personalized cancer treatment with higher efficacies and improved outcomes. CGI has actively developed and validated PD-L1 markers for a wide range of cancers, including: melanoma, NSCLC, head and neck, breast, gastric, colon, bladder, pancreatic, renal, prostate, and ovarian cancers, urothelial carcinoma, mesothelioma, and B-cell lymphomas. CGI believes that it has validated, under a compliant and CLIA regulated setting, PD-L1 testing across more cancer indications than any other commercial cancer laboratory. Because of this, the company expects to have significant continued acceleration in the number of immuno-oncology studies and clinical trials that it is providing testing and information for in the coming quarters in both PD-L1 and other key immune markers.

“KEYTRUDA’s approval as a first-line treatment will make PD-L1 expression testing more common for both squamous and nonsquamous lung cancers, and will mark an accelerated era of IO awareness and testing for cancer treatment. We are very excited to be on Merck’s list as we have demonstrated again that CGI is at the forefront of enabling precision diagnostics in immuno-oncology, and then bringing these advances into a large-scale clinical setting so that patients can ultimately benefit,” said CGI President and CEO, Panna Sharma.

Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody that is being studied in a broad range of solid tumors and hematological malignancies. It has been granted Breakthrough Therapy Designation status by the FDA four times for the treatment of patients with melanoma, NSCLC, colorectal cancer, and classical Hodgkin lymphoma. Pembrolizumab (KEYTRUDA®) is now indicated for the treatment of patients with NSCLC, melanoma, and head and neck cancer.  KEYTRUDA® sales were already growing rapidly, but following KEYTRUDA’s first-line approval analysts have adjusted peak sale estimates. For example, Bernstein analysts have increased their KEYTRUDA® outlook for 2017 by $1 billion and they now expect KEYTRUDA® sales of $7.8 billion in 2025 which will require a significantly higher number of patients to be tested and diagnosed.

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 of 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:
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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 future financial and/or operating results and potential for our tests and services, and future revenues or growth 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 September 30, 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.


Panna Sharma
Cancer Genetics, Inc.