On October 29, 2018 Epic Sciences, Inc. (Epic) and Genomic Health, Inc. (Nasdaq: GHDX) reported that Palmetto GBA, a Medicare Administrative Contractor that assesses molecular diagnostic technologies, has issued a positive final local coverage determination (LCD) for the Oncotype DX AR-V7 Nucleus Detect test (Press release, Genomic Health, OCT 29, 2018, View Source [SID1234530442]). The final LCD recommends Medicare coverage for use of the test effective December 10, 2018, throughout the United States to help determine which patients with metastatic castrate resistant prostate cancer (mCRPC) may benefit from continued androgen receptor signaling inhibitor (ARSi) therapy, such as enzalutamide, abiraterone and apalutamide, as well as those who are resistant who may benefit from chemotherapy.
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An estimated 50,000 men in the United States with advanced prostate cancer, of which approximately 25,000 have Medicare coverage, could benefit from knowing their AR-V7 status prior to selecting further treatment. The Oncotype DX AR-V7 Nucleus Detect test is a circulating tumor cell-based liquid biopsy test that is commercially available in the United States through Epic’s partnership with Genomic Health. The final LCD is posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website.
The test, commercially launched by Genomic Health on February 28, 2018, is supported by three clinical utility studies including two multicenter validation studies. Results from a Memorial Sloan Kettering Cancer Center-led validation study were published online on June 28, 2018, in JAMA Oncology, establishing the predictive benefit of the test. Additionally, new validation data from the PROPHECY study were presented on June 4, 2018, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
"For men with advanced prostate cancer, these independent, blinded, multicenter studies demonstrated that the Oncotype DX AR-V7 Nucleus Detect test is a clinically validated and useful test that can predict therapeutic response and, through its use, extend life. Importantly, with this final Medicare LCD, approximately 50 percent of addressable patients in the United States can gain access to the test," said Murali Prahalad, Ph.D., President and CEO of Epic Sciences. "Receiving a positive, final LCD for the test less than a year after commercial launch speaks to the importance and impact that this test has in improving patient survival."
Prior to the Oncotype DX AR-V7 Nucleus Detect test, there was no clear consensus on the therapeutic sequencing after initial exposure to an ARSi therapy. The most challenging clinical decision in mCRPC is whether to start a second ARSi therapy or taxane chemotherapy. Detection of nuclear-specific AR-V7-positive circulating tumor cells as measured by the Epic Sciences approach indicates which patients are resistant to AR-targeted therapies, such as enzalutamide, abiraterone and apalutamide, as well as those who are likely to live longer when placed on chemotherapy rather than on ARSi therapy. Conversely, patients negative for nuclear-localized AR-V7 are likely to live longer with ARSi therapy than with chemotherapy.
The Oncotype DX AR-V7 Nucleus Detect test was developed using Epic’s proprietary No Cell Left Behind technology. Epic is delivering a portfolio of blood-based tests that are predictive of drug response in cancer and are clinically proven, personalized and focused on improving patient survival and healthcare economics worldwide.
About the Oncotype DX AR-V7 Nucleus Detect Test
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 is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and is offered exclusively by Genomic Health. To learn more about the Oncotype DX AR-V7 Nucleus Detest test, visit www.OncotypeIQ.com and watch this video.