New Published Data and Recent Positive Private Payor Coverage Decisions Underscore Value and Utility of the Oncotype DX Genomic Prostate Score® (GPS™) Test
REDWOOD CITY, Calif., Sept. 28, 2018
REDWOOD CITY, Calif., Sept. 28, 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 compared to no testing. Results of this new analysis, published in Reviews in Urology, build on the original study by using propensity score matching and coarsened exact matching to increase the confidence in the impact of GPS testing in clinical practice. To date, the collective published clinical utility evidence for the GPS test includes four studies in nearly 9,000 men, demonstrating the actionable impact of the GPS test in treatment planning.
Using the original study of 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 new analysis of more than 7,000 de-identified patient records assessed active surveillance use for patients evaluated with the GPS test. Results reconfirmed the original finding that active surveillance use was 30 percent higher in men who received the GPS test than in those who did not.
"This publication of the new, rigorous analysis confirms the previously-published original study results, highlighting the role of the Oncotype DX GPS test in driving more guideline-based recommendations for patients with clinically low-risk disease," said Steven Canfield, M.D, chief of urology at UT Health McGovern Medical School and lead author of the Optum study.
Separately, an independent study published by University of California, San Francisco (UCSF) researchers in the Journal of Urology demonstrated that the Oncotype DX GPS test was associated with an increased risk of biopsy upgrade in men with clinically low-risk prostate cancer managed by active surveillance. The results of this study showed an independent continuous association between the GPS results and the increased risk of biopsy upgrade. Moreover, results showed that based on the positive predictive value of the GPS test for the UCSF cohort, a GPS score of greater than 29 demonstrated higher patient incidence of failure on active surveillance within three years following biopsy. These data underscore the independent clinical value of the GPS test in identifying patients with more aggressive tumor biology who should be more aggressively managed.
"Growing clinical evidence, combined with NCCN's updated guidelines and multiple positive private payor coverage decisions, is increasing access to the GPS test to all eligible patients in the U.S. This enables optimal use of active surveillance to spare unnecessary side effects and reduce healthcare costs," said Steven Shak, M.D., chief scientific officer, Genomic Health.
In recent months, multiple private insurers, including a top five national payor, established new coverage for the GPS test, bringing the total number of U.S. covered lives to more than 92 million, including Medicare.
About the Oncotype DX® Genomic Prostate Score™ Test
Developed by Genomic Health based on results from multiple studies led by Cleveland Clinic and the University of California, San Francisco, the Oncotype DX® GPS test is the only genomic assay designed for men with clinically low-risk or favorable intermediate-risk cancer to help make treatment decisions at the time of diagnosis. The test analyzes 17 genes across four biological pathways from tumor tissue removed during biopsy to provide a GPS result with a score ranging from 0-100 that corresponds to the biologic aggressiveness of the tumor and the patient's likelihood of prostate cancer metastasis and death at 10 years. The GPS test is included within NCCN Guidelines® as a Category 2A molecular testing option for consideration in prostate cancer patients with clinically low-risk and favorable intermediate-risk disease and is covered by Medicare and multiple private insurance companies in the United States. 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 900,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype DX® AR-V7 Nucleus Detect™ 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 utility studies on market adoption and test 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 June 30, 2018. 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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