REDWOOD CITY, Calif., March 29, 2017 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of new results from a large multi-center validation study, which confirmed that the Oncotype DX® Genomic Prostate Score™ (GPS) is a strong independent predictor of metastases at 10 years in prostate cancer patients across all National Comprehensive Cancer Network (NCCN) clinical risk groups. The clinical validation study data were designated one of the "best posters" (abstract #352) at the 32nd Annual European Association of Urology (EAU) Congress in London
"Now validated for all major near- and late-term endpoints of adverse pathology, biochemical recurrence, metastasis and prostate cancer-specific death, Oncotype DX becomes the only genomic test to provide physicians with an assessment of both the current state and future risk of their patient's cancer based on biology to help them confidently decide between active surveillance or surgery," said Phil Febbo, M.D., chief medical officer, Genomic Health. "We believe the breadth of clinical evidence from 22 studies in more than 4,200 patients further supports the test's broader adoption in the U.S."
Researchers evaluated biopsy tissue from 259 patients in Kaiser Permanente's Northern California region, identified from a database of men treated with radical prostatectomy and diagnosed with low-, intermediate- or high-risk prostate cancer. The majority of patients (67%) included in this study had intermediate-risk disease.
Results showed a range of 10-year risk within each NCCN risk group and confirmed that the GPS was strongly associated with metastases (p < 0.001) in multivariable analysis when compared to other risk criteria and provided additional independent information about tumor aggressiveness and long-term outcomes. An additional key finding was that that no patients with low- or intermediate-risk prostate cancer and a GPS result of less than 20 developed metastatic disease following radical prostatectomy.
"It is important to seek ways to better understand how to tell a man with newly diagnosed prostate cancer what his risk of developing metastatic disease or dying of the disease is," said Stephen Van Den Eeden, Ph.D., Kaiser Permanente Division of Research, Oakland, Calif. "Our study suggests that this test may help some men and their physicians make better decisions on whether to pursue active surveillance or receive definitive treatment."
Additional results from this clinical validation study using Kaiser Permanente data, which also analyzed the GPS performance in predicting prostate cancer-specific mortality in patients with early-stage disease, have been accepted for presentation at the American Urological Association 2017 Annual Meeting in May.
About the Oncotype DX® Genomic Prostate Score™
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 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 a man's risk prior to treatment intervention. The test enables confident treatment decisions to provide the opportunity for low-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, 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 help optimize cancer care by 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 700,000 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™. 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: our business model; the applicability of clinical study results to actual outcomes; the impact of results from clinical studies on market adoption of Oncotype DX tests, our ability to develop and commercialize new tests and expand into new markets domestically and internationally; 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-K for the year ended December 31, 2016. 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, 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.