Genomic Health has commercially launched the Oncotype DX AR-V7 Nucleus Detect test in the US.
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.
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 study 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.
Genomic Health CEO Jamie Bearse said: "AR-V7 is an exciting breakthrough in fighting prostate cancer as it immensely helps in determining the best treatment pathways for patients.”
"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."
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.
Designed by Epic Sciences and based on results from multiple studies led by Memorial Sloan Kettering Cancer Center, the Oncotype DX® AR-V7 Nucleus Detect™ test is the first and only liquid biopsy test of its kind that can potentially prolong the lives of men with metastatic castration-resistant prostate cancer (mCRPC) by helping their physician identify the most effective treatment.
Through a blood draw, the test detects AR-V7 protein in the nucleus of circulating tumor cells utilizing Epic Sciences' No Cell Left Behind® platform to accurately identify patients who are resistant to androgen receptor (AR)-targeted therapies and who should instead switch to chemotherapy. The Oncotype DX® AR-V7 Nucleus Detect™ test will be performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego, Calif.