Launch of Oncotype DX® AR-V7 Nucleus Detect™ Test Expands Offering to Prostate Cancer Patients - Predicting Treatment Response in Metastatic Disease

Truckee, CA ( Genomic Health, Inc. (NASDAQ: GHDX) announced the U.S. commercial launch of the Oncotype DX® AR-V7 Nucleus Detect™ test. The first and only liquid biopsy test of its kind, 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). Knowledge of a patient’s AR-V7 status enables physicians to confidently decide whether men treated with an androgen receptor-signaling inhibitor (ARSI) therapy, such as enzalutamide and abiraterone, need to start another type of ARSI or switch to chemotherapy.

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.

“Virtually all men with metastatic prostate cancer eventually develop mCRPC, and a substantial portion of these patients’ cancers acquire androgen receptor splice variants that cause drug resistance. This can lead to the use of costly, ineffective hormonal therapies that result in poor patient outcomes,” said William R. Berry, M.D., clinical associate in the Department of Medicine at Duke University School of Medicine. “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.”

Powered by Epic Sciences’ proprietary No Cell Left Behind® platform, the Oncotype DX AR-V7 Nucleus Detect test has been validated to accurately identify 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. Findings from the first validation studyy were published in JAMA Oncology in 2016. Results from the second validation study were presented at the 2018 Genitourinary Cancers Symposium of the American Society of Clinical Oncology and submitted for publication in a major peer-reviewed journal.

“AR-V7 is an exciting breakthrough in fighting prostate cancer as it immensely helps in determining the best treatment pathways for patients,” said 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.”  
“The technology from our collaboration partner, Epic Sciences, powers the Oncotype DX AR-V7 Nucleus Detect test, providing an unbiased approach to minimize the risk of CTCs being missed, resulting in superior test performance, sensitivity and specificity,” said Phil Febbo, M.D., chief medical officer, Genomic Health. “The launch of the Oncotype DX AR-V7 Nucleus Detect test marks an important step forward in our mission to use biology to guide care across the prostate cancer continuum by providing urologists with a suite of actionable genomic tests.”

With the Oncotype DX Genomic Prostate Score™ test for early-stage, low- and intermediate-risk patients, the Oncotype DX AR-V7 Nucleus Detect test for metastatic patients, and a recent collaboration with Cleveland Diagnostics to develop new tests to accurately predict the presence of high-grade cancer prior to prostate biopsy, Genomic Health is well positioned to offer urologists a full portfolio of diagnostic tests that answer critical clinical questions across the spectrum of the disease.

Read More:

Strategic Collaboration to Deliver Novel AR-V7 Liquid Biopsy Test to Predict Treatment Response in Metastatic Prostate Cancer (mCRPC) announced by Genomic Health and Epic Sciences.

Association of AR-V7 on Circulating Tumor Cells as a Treatment-Specific Biomarker With Outcomes and Survival in Castration-Resistant Prostate Cancer.