Oncotype DX AR-V7 Nucleus Detect test launched in US for prostate cancer identification.- Genomic Health.

Genomic Health has announced the U.S. commercial launch of the Oncotype DX AR-V7 Nucleus Detect test. The first 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).

Through a blood draw, the test detects AR-V7 protein in the nucleus of circulating tumor cells utilizing Epic Sciences' platform to accurately identify patients who are resistant to androgen receptor (AR)-targeted therapies and who should instead switch to chemotherapy.

Two clinical validation studies, led by Memorial Sloan Kettering Cancer Center 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 study were published in JAMA Oncology in 2016. Results from the second validation study were presented at the 2018 Genitourinary Cancers Symposium.