Genomic Health's Oncotype DX® Prostate Cancer Test Receives Medicare Coverage

Decision Brings Precision Medicine to Nearly 60,000 Prostate Cancer Patients

Aug 17, 2015, 08:00 ET from Genomic Health, Inc.

REDWOOD CITY, Calif., Aug. 17, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued its final local coverage determination (LCD) approving coverage of the Oncotype DX® prostate cancer test for qualified Medicare patients throughout the United States.

"With Medicare's coverage, each year, nearly 60,000 prostate cancer patients and their physicians will now have the opportunity to make more optimal treatment decisions based on the unique biological information revealed by the Oncotype DX Genomic Prostate Score," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "This marks an important milestone in our work to expand the impact of our Oncotype DX platform to meet a significant need for prostate cancer patients and represents a large 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 clinical and pathological factors such as prostate-specific antigen (PSA) and Gleason score.  The effective date for Medicare coverage will be after the 45-day notice period according to Palmetto GBA's process.

With 14 prostate cancer studies that have included more than 2,000 patients, Oncotype DX is the only genomic test that has been validated to predict both near- and long-term outcomes, and addresses the most clinically actionable question of adverse pathology remaining in the prostate to enable more precise patient risk stratification and better informed treatment decisions.

"More than 50 percent of newly diagnosed men have low-risk prostate cancer that is unlikely to spread, yet a majority of them receive immediate aggressive treatment resulting in unnecessary surgery and radiation," said Phil Febbo, M.D., chief medical officer, Genomic Health.  "A recently published multi-center review of patient charts showed a relative increase of 56 percent in the use of active surveillance in patients who received their Oncotype DX GPS compared to patients from the same practices with similar risk factors who were not tested." 

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.

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SOURCE Genomic Health, Inc.



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