Genomic Health Announces Positive Topline Clinical Validation Study Results Demonstrating Oncotype DX Prostate Cancer Test Predicts Risk Of Metastasis And Mortality
Published: Nov 02, 2016
REDWOOD CITY, Calif., Nov. 1, 2016 /PRNewswire/ -- Genomic Health, Inc. (NASDAQ: GHDX) today announced topline results from a large clinical validation study of its biopsy-based Oncotype DX® Genomic Prostate Score (GPS). The study, performed in collaboration with a large integrated healthcare system, met its primary endpoint by demonstrating that the multi-gene Oncotype DX® test, assessed in prostate needle biopsy tumor tissue, is a strong predictor of the development of metastasis and prostate cancer death in patients with early-stage prostate cancer. With these new results, the Oncotype DX test becomes the first genomic test validated in all major short- and long-term end points: adverse pathology, biochemical recurrence, metastasis and prostate cancer-specific death.
"As part of our commitment to provide urologists with actionable biological information to guide treatment decisions, we have investigated our test's ability to predict all critical features of tumor aggressiveness in early-stage prostate cancer," said Phil Febbo, M.D., chief medical officer, Genomic Health. "Adding to 21 clinical studies in more than 3,600 patients, we believe this new data will expand and reinforce the clinical utility of the Oncotype DX test and lead to increased adoption of the test by physicians and patients making critical treatment decisions."
The complete data analyses will be submitted for presentations at major urological meetings in 2017.
Designed by Genomic Health based on the results from multiple studies led by Cleveland Clinic and University of California, San Francisco, the Oncotype DX GPS analyzes 17 genes across four biological pathways from tumor tissue removed during the 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 invasive treatment.
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 more than 700,000 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 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 assay. 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 the other risks and uncertainties set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended June 30, 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, Oncotype DX Genomic Prostate Score, Recurrence Score, DCIS Score, Oncotype SEQ, Oncotype SEQ Liquid Select, 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.