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Epic Sciences Nabs NY State Approval for AR-V7 Prostate Cancer Test

NEW YORK (360Dx) – Epic Sciences said today that its lab is now licensed by the New York State Department of Health to provide its Oncotype DX AR-V7 Nucleus Detect test for residents with metastatic castration-resistant prostate cancer.

The assay, which has already been available for patients in other states under the lab's CLIA certification and is marketed by Genomic Health, uses Epic Sciences' proprietary circulating tumor cell platform to identify the presence of AR-V7 protein in these cells' nuclei.

Studies by the company and its academic collaborators — including one published in JAMA Oncology last year — have shown that the presence or absence of nuclear AR-V7 in CTCs can help predict which patients are likely to respond well to androgen receptor signaling inhibitor drugs and which may benefit more from chemotherapy.

Last October, Palmetto GBA finalized its positive local coverage determination, providing coverage for the test, effective December 10, 2018, for qualified patients. Specifically, the test is covered for patients who have failed on one of the two widely used AR drugs — Xtandi (enzalutamide) and Zytiga (abiraterone) — and who are being considered for treatment with the other.