RUTHERFORD, N.J. USA 15 May 2017 (GLOBE NEWSWIRE) — Cancer Genetics, Inc. (Nasdaq: CGIX) (“CGI” or “The Company”), a leader in precision diagnostics for oncology, announced today that it has partnered with Ventana Medical Systems, Inc., a member of the Roche Group (Roche), to enable rapid patient access to testing following the FDA’s recent approval of Roche’s VENTANA PD-L1 (SP263) Assay.
CGI participated in a new program launched by Ventana that provides pre-launch pathologist training and supports the lab in validating the assay to ensure early availability of testing. The agreement ensures that CGI is one of the first laboratories in the United States with pathologists trained to use and interpret the VENTANA PD-L1 (SP263) test to help inform patient treatment decisions. Prequalification of select laboratories ensures patients have immediate access to the PD-L1 (SP263) test across the United States.
The use of the VENTANA PD-L1 (SP263) Assay for PD-L1 expression testing in either tumor or immune cell membranes in urothelial carcinoma may be a useful tool to help determine the likelihood of responding to the anti-PD-L1 immuno-oncology (IO) therapy IMFINZI™ (durvalumab), developed by AstraZeneca, but is not required for use of IMFINZI.
Urothelial carcinoma, a disease with an unmet need for new therapies, is the most common type of bladder cancer (over 90%) and encompasses cancers of the ureters, urethra, and renal pelvis. It is estimated that in 2017, approximately 79,000 Americans will be diagnosed with bladder cancer, and almost 17,000 will die from this disease.[1]
“CGI is very well positioned to provide broad and rapid access to the VENTANA PD-L1 (SP263) Assay and thereby support potentially lifesaving treatment decisions. We are very excited to have been selected by Roche as we see ourselves at the forefront of enabling precision diagnostics in immuno-oncology. We are pleased about the opportunity to bring these advances into a large-scale clinical setting benefiting patients,” said CGI President and CEO Panna Sharma.
[1] American Cancer Society 2017 Facts and Figures/pg 29/col 1/para 4/lines 1-2
About durvalumab; IMFINZI™ (durvalumab) is a human monoclonal antibody directed against PD-L1. Durvalumab is also being studied in the first-line treatment of patients with unresectable and metastatic bladder cancer as a monotherapy and in combination with tremelimumab, a checkpoint inhibitor that targets CTLA-4, as part of the DANUBE Phase III trial, which enrolled its first patient during the fourth quarter of 2015. Additional clinical trials are ongoing to investigate durvalumab as monotherapy or in combination with tremelimumab in non-small cell lung cancer, head and neck squamous cell carcinoma, bladder, hepatocellular carcinoma and blood cancers. IMFINZI is a trademark of the AstraZeneca group of companies and is manufactured and distributed by AstraZeneca.
