Oncotype DX® Genomic Prostate Score™ Test Increases Use of Active Surveillance by 30 Percent in Low-risk Patients, Resulting in Greater Adherence to Guideline-based Care
Unprecedented Study of Nearly 10,000 Patient Medical Records from Large Private U.S. Health Insurer Published in Reviews in Urology
REDWOOD CITY, Calif., Feb. 5, 2018 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the publication of real-world clinical evidence demonstrating that use of the Oncotype DX® Genomic Prostate Score™ (GPS™) test resulted in significantly higher use of active surveillance at six and 12 months compared to no testing within the same time period. Results of this large, independently conducted study, published in Reviews in Urology, bring the collective published clinical utility evidence to four studies in nearly 8,300 men, demonstrating the actionable impact of the GPS test in treatment planning.
"As the largest clinical utility study of a genomic test in prostate cancer patients to date, this publication solidifies the mounting evidence for the role of GPS testing in the initial management of early prostate cancer and its ability to appropriately direct active surveillance use among low-risk patients. No other test has this type of impact on driving guideline-based recommendations for these patients," said Steven Canfield, M.D., chief of urology at UT Health McGovern Medical School and lead author of the study.
Using the Optum™ Research Database of electronic health records and administrative claims from a large U.S. health insurer offering both commercial and Medicare Advantage health plans, the study reviewed nearly 10,000 de-identified patient records to assess active surveillance use for patients tested with the Oncotype DX GPS test. Results showed that active surveillance use was more than 30 percent higher in men who received the GPS test than in men who did not receive the genomic test.
"There is remarkable consistency across four published clinical utility studies demonstrating a substantial increase in the use of active surveillance with the GPS test," said Phil Febbo, M.D., chief medical officer, Genomic Health. "We believe this breadth of compelling clinical evidence will drive broad private reimbursement beyond Medicare, which will enable more men in the United States to benefit from the GPS test this year."
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 850,000 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. 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 applicability of clinical study results to actual outcomes; the impact of results from clinical studies on market adoption and utilization of Oncotype DX tests; unanticipated costs or delays in research and development efforts; and other risks and uncertainties set forth in our filings with the Securities and Exchange Commission, including our most recent report on Form 10-Q for the quarter ended September 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, Liquid Select, Genomic Prostate Score, Oncotype DX AR-V7 Nucleus Detect 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.
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SOURCE Genomic Health, Inc.
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