Medicare Establishes Final Local Coverage Determination (LCD) for Use of the Oncotype DX® Genomic Prostate Score™ Test in Patients with Favorable Intermediate-risk Prostate Cancer Effective October 9, 2017
REDWOOD CITY, Calif., Aug. 24, 2017 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a positive final Local Coverage Determination (LCD) to expand Medicare coverage of the Oncotype DX® Genomic Prostate Score™ (GPS™) test. The final LCD, recommending Medicare coverage for use of the test in qualified patients with favorable intermediate-risk prostate cancer throughout the United States, is scheduled to take effect on October 9, 2017.
"With this additional Medicare coverage we can now broaden the impact of Oncotype DX, the only genomic test validated to predict both the current risk of adverse pathology and future risk of metastasis and death due to prostate cancer, to men with favorable intermediate-risk prostate cancer as defined by the National Comprehensive Cancer Network (NCCN)," said Phil Febbo, M.D., chief medical officer, Genomic Health.
Once the final LCD becomes effective, an estimated 20,000 additional men will have access to the test to help them more confidently decide between active surveillance or immediate intervention. This adds to the existing 50,000 low-risk patients who have been covered by Medicare since 2015 and brings the total number of Medicare patients eligible for GPS test coverage to 70,000.
The final LCD is posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website. Once final, LCDs are subject to annual review by MACs; as such, Genomic Health will continue to generate scientific data and publications to demonstrate enhanced clinical utility of the GPS test.
About the Oncotype DX® Genomic Prostate Score™ Test Designed by Genomic Health based on results from multiple studies led by Cleveland Clinic and the University of California, San Francisco, the Oncotype DX Genomic Prostate Score test analyzes 17 genes across four biological pathways from tumor tissue removed during biopsy to provide an individual score that, in combination with other clinical factors, further clarifies the current and future risk of the cancer prior to treatment intervention. The test enables confident treatment decisions to provide the opportunity for low- and intermediate-risk patients to avoid prostatectomy or radiation - and their side effects - while identifying men who need immediate definitive treatment. To learn more about the Oncotype DX Genomic Prostate Score test, visit www.OncotypeIQ.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 help optimize cancer care, including addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX® gene expression tests that have been used to guide treatment decisions for more than 800,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype SEQ® Liquid Select™ test. The company is based in Redwood City, California, with international 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 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 risk that the company may not obtain or maintain adequate levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop including Medicare coverage for its Oncotype DX Genomic Prostate Score test in favorable intermediate-risk prostate cancer patients; the ability of the company to achieve expanded coverage of reimbursement for its existing tests and the ability of any such expanded coverage to result in additional revenue; the ability of test results to change treatment decisions; the risks of competition; 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 and the ability to demonstrate sufficient clinical utility; 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 our most recent report on Form 10-Q for the quarter ended June 30, 2017. 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, DCIS Score, Oncotype SEQ, Oncotype DX Genomic Prostate Score, Oncotype DX AR-V7 Nucleus Detect, Liquid Select and Oncotype IQ are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.