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Epic Sciences, Genomic Health Receive Favorable Draft LCD for Prostate Cancer AR-V7 Test

NEW YORK (GenomeWeb) – Epic Sciences and Genomic Health said today that Medicare contractor Palmetto GBA has issued a draft local coverage determination (LCD) for the Oncotype DX AR-V7 Nucleus Detect test.

The companies said that if finalized, the LCD would extend coverage of the test to 25,000 Medicare patients with advanced prostate cancer.

The draft recommends limited coverage for use of the test to help determine which patients with metastatic castration-resistant prostate cancer may benefit from androgen receptor signaling inhibitor therapy and which may benefit from chemotherapy.

Developed by Epic and offered through its lab, the test analyzes AR-V7 expression in the nuclei of circulating tumor cells. Genomic Health partnered with Epic in 2016 to bring the assay to market, and launched it commercially earlier this year.

"The rapid issuance of the draft LCD … highlights the clinical utility and value of this new test in prolonging survival for men with metastatic castration-resistant prostate cancer," Epic Sciences CEO Murali Prahalad said in a statement.

Data collected by Epic in its studies of the test have shown that detection of AR-V7-positive CTCs indicates that a patient will no longer benefit from commonly prescribed AR inhibitor therapies but may have better survival if switched to chemotherapy.

The draft LCD will now go through a review process, including a public comment period that began on March 26, before being finalized.