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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
"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
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
About Genomic Health
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
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