Epic, Genomic announce favorable draft local coverage determination
Epic Sciences and Genomic Health (GHDX) announced that Palmetto GBA, a Medicare Administrative Contractor that assesses molecular diagnostic technologies, has issued a draft local coverage determination for the Oncotype DX AR-V7 Nucleus Detect test. The draft LCD recommends Medicare coverage for use of the test throughout the United States to help determine which patients with metastatic castration-resistant prostate cancer may benefit from androgen receptor signaling inhibitor (ARSi) therapy and which may benefit from chemotherapy, the companies said in a statement. 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. "Prior to the Oncotype DX AR-V7 Nucleus Detect test, there was no clear consensus on therapeutic sequencing after initial exposure to an ARSi therapy, and the most common clinical decision in mCRPC was whether to start a second ARSi or taxane chemotherapy," Epic and Genomic write. Murali Prahalad, CEO of Epic Sciences, said, "The rapid issuance of the draft LCD recommending Medicare coverage highlights the clinical utility and value of this new test in prolonging survival for men with metastatic castration-resistant prostate cancer."