Genomic Health launches Oncotype DX AR-V7 Nuclear Detect Test
Genomic Health asserted the U.S commercial launch of Oncotype DX AR-V7 Nucleus Detect test. The Oncotype DX AR-V7 Nucleus Detect test was developed by Epic Sciences to help prolong the lives of men with metastatic castration-resistant prostate cancer (mCRPC) by accurately detecting a splice variant of the androgen receptor protein (AR-V7) in the nucleus of circulating tumor cells (CTCs).
The AR-V7 protein is a prognostic and predictive biomarker. Detection of AR-V7-positive tumor cells by the Oncotype DX test indicates that the patient will no longer benefit from commonly prescribed ARSI therapies but can still benefit from chemotherapy to prolong survival. An estimated 50,000 men in the U.S. with advanced prostate cancer could benefit from knowing their AR-V7 status prior to selecting further treatment.
William R. Berry, M.D., clinical associate in the Department of Medicine at Duke University School of Medicine said “By enabling a tailored treatment approach with Oncotype DX AR-V7 Nucleus Detect, we may improve patient survival in a cost-efficient manner for the health system.”
The Oncotype DX AR-V7 Nucleus Detect test has been corroborated and manifested to accurately ascertain men who are positive for AR-V7 from a single blood draw and a binary result. Two clinical validation studies, led by Memorial Sloan Kettering Cancer Center (MSK) across multiple sites, collectively included 360 patients and demonstrated that men who are AR-V7 positive and treated with chemotherapy survive longer than those on ARSI therapy. Results also demonstrated that approximately 20 percent of men who received initial ARSI treatment became AR-V7 positive and developed drug resistance as a result.
Jamie Bearse, chief executive officer, ZERO – The End of Prostate Cancer “Men and families face anxiety and tough decisions over treatments but this tool, for example, will enable those men to make determinations like when to move on from hormonal therapy to chemotherapy to improve patient outcomes.”