Genomic Health Announces Publication of Oncotype DX® Prostate Cancer Test Decision Impact Study in Urology Practice, Supporting Wider Adoption and Reimbursement
Use of Test Significantly Impacts Treatment Recommendations for One in Four Men and Improves Confidence in 85 Percent of Physicians
REDWOOD CITY, Calif., April 30, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that Urology Practice, an official journal of the American Urological Association (AUA), published positive results from the first decision impact study of the Oncotype DX® prostate cancer test. Results showed that use of the test substantially increased the number of men who can consider active surveillance, while increasing physician confidence in their treatment recommendations.
"By providing a way to refine risk assessment based on a patient's specific tumor biology, this genomic test allows physicians to confidently determine the best individualized treatment option for each man," said Ketan K. Badani, M.D., who led the study while at Columbia University, and who is currently vice chairman of Urology and Robotic Operations at Mount Sinai Health System, New York.
This prospective study involving 158 newly diagnosed prostate cancer patients showed that incorporation of the Genomic Prostate Score (GPS) changed modality and/or intensity of treatment recommendations in 26 percent of patients across multiple urology practice settings. The NCCN low risk group showed the greatest absolute recommendation change of 37 percent. The increase in recommendations for active surveillance was 24 percent. Additionally, 85 percent of urologists were more confident in their treatment recommendation following review of the GPS.
"These data underscore the significant impact that Oncotype DX has on treatment recommendations and suggest that use of our assay will decrease the burden of low-risk prostate cancer by helping physicians reduce unnecessary immediate treatment while helping identify those who would benefit from invasive treatment at diagnosis," said Phil Febbo, M.D., chief medical officer, Genomic Health. "We believe this publication, along with our second clinical utility study that has been accepted for publication, further strengthens our efforts to secure reimbursement."
The study was conducted in collaboration with academic and community practices at Columbia University, Delaware Valley Urology and Orange County Urology.
Results from the second Oncotype DX prostate cancer test decision impact study have been accepted for future publication in Urology Practice.
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 low- to intermediate-risk patients eligible for active surveillance, as well as those who may benefit from immediate invasive treatment by predicting disease aggressiveness. With half a million patients tested in more than 70 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 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 attributes and benefits of the company's tests to physicians, patients and payors; and the belief that publication of the study and a second clinical utility study will lead to increased usage and secure reimbursement. 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 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; the company's ability to obtain capital when needed 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 annual report on Form 10-K for the year ended December 31, 2014. 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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