Genomic Health Announces Favorable Draft Local Coverage Determination from Palmetto GBA on Medicare Coverage for the Oncotype DX Prostate Cancer Test

Genomic Health, Inc. GHDX today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a draft local coverage determination (LCD) for the Oncotype DX® prostate cancer test. The draft LCD recommends coverage of the Oncotype DX prostate cancer test for qualified Medicare patients throughout the United States "to help determine which patients with early-stage, needle biopsy proven prostate cancer, can be conservatively managed rather than treated with definitive surgery or radiation therapy." "We are very pleased with this draft coverage determination. It is an important step toward ensuring that all prostate cancer patients covered by Medicare, which represents 50 percent of the population eligible for our test, have access to the unique biological information provided by Oncotype DX in order to more precisely assess their cancer's aggressiveness and for their physicians to determine the optimal treatment," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. The draft LCD is posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website. It will go through Medicare's review process, which includes a public comment period, finalization and notification. Palmetto's positive draft local coverage decision follows multiple new Oncotype DX data presentations at the 2015 American Urological Association Annual Meeting. The results from three studies documented the real-world positive impact of the Oncotype DX Genomic Prostate Score (GPS) and the test's value in managing healthcare costs associated with treatment decisions in low-risk patients. With 11 prostate cancer studies that have included more than 1,500 patients, Oncotype DX is the only genomic test that has been validated to predict both near- and long-term outcomes and answers the most clinically actionable question of adverse pathology to enable more precise patient risk stratification and better informed treatment decisions. To date more than 1,800 physicians have used the Oncotype DX prostate cancer test to plan treatment decisions for their patients.