REDWOOD CITY, Calif., May 21, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: 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.
About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The Oncotype DX prostate cancer test identifies which clinically low-risk patients are eligible for active surveillance, as well as those who may benefit from immediate treatment by predicting disease aggressiveness. With half a million patients tested in more than 80 countries, the Oncotype DX testing has redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX prostate cancer test, visit www.OncotypeDX.com or www.myprostatecancertreatment.org.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring. The company is based in Redwood City, California, with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's belief that the draft LCD is an important step toward ensuring that all prostate cancer patients covered by Medicare have access to the test; and the benefits of the test to physicians, patients and payors. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the issuance by Palmetto of an LCD and the scope of any such LCD; the ability of test results to change treatment decisions in the clinical setting; the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's quarterly report on Form 10-Q for the year ended March 31, 2015. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
SOURCE Genomic Health, Inc.