NEW YORK (GenomeWeb) – Epic Sciences and Genomic Health said today that Medicare Administrative Contractor Palmetto GBA has issued a positive final local coverage determination (LCD) for the Oncotype DX AR-V7 Nucleus Detect test, which was developed and continues to be performed by Epic Sciences.
Palmetto released its draft LCD for the test this March. The final determination recommends limited coverage for use of the test throughout the US to help determine which patients with metastatic castrate-resistant prostate cancer may benefit from continued androgen receptor signaling inhibitor therapy — using drugs like enzalutamide, abiraterone, and apalutamide — and which may be better served by chemotherapy.
The assay uses Epic's "No Cell Left Behind" circulating tumor cell analysis platform to identify AR-V7 positivity in CTC nuclei. Genomic Health partnered with Epic in 2016 to bring the assay to market, and launched it commercially this February.
Studies of the test, including a validation published this June in JAMA Oncology, have shown that detection of AR-V7-positive CTCs indicates that a patient will no longer benefit from commonly prescribed AR inhibitor therapies and will have better survival if switched to chemotherapy.