Genomic Health, Inc. announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has initiated reimbursement coverage of the Oncotype DX® prostate cancer test for qualified Medicare patients throughout the United States effective immediately.
“Now, each year, up to an estimated 60,000 eligible Medicare prostate cancer patients and their physicians have access to the unique biological information revealed by the Oncotype DX Genomic Prostate Score in order to optimize treatment decisions,” said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. “This decision marks an important milestone in our efforts to bring precision medicine to more patients and represents a significant growth opportunity for Genomic Health.”
More than 220,000 men are diagnosed with prostate cancer each year in the United States alone. The Medicare coverage decision extends reimbursement for Oncotype DX testing to prostate cancer patients defined as low- and very low-risk by the National Comprehensive Cancer Network (NCCN), who are eligible based on specific Medicare criteria including clinical and pathological factors such as prostate-specific antigen (PSA) and Gleason score.
“With 14 studies that have included more than 2,000 patients, our test has been specifically developed and validated to assess the aggressiveness of prostate cancer and predict both near- and long-term outcomes to enable more precise patient risk stratification and better informed treatment decisions,” said Phil Febbo, M.D., chief medical officer, Genomic Health.
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 90 countries, 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 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 company’s belief that the 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 June 30, 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. press release.