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Genomic Health Announces Positive Topline Results of Additional, Large Independent Validation Study of Oncotype DX® Prostate Cancer Test with Multiple Clinical Endpoints
Study Achieved Primary Endpoint of Predicting Recurrence after Surgery and Reconfirmed Original Adverse Pathology Endpoint from Published UCSF Validation Study
|By PR Newswire
|August 6, 2014 08:01 AM EDT
REDWOOD CITY, Calif., Aug. 6, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive preliminary results from an additional independent clinical validation study conducted by the Center for Prostate Disease Research (CPDR) demonstrating that the Oncotype DX® Genomic Prostate Score (GPS) predicts multiple clinical endpoints related to disease aggressiveness in men with low- and intermediate-risk prostate cancer. This study validated the Oncotype DX prostate cancer test as a predictor of biochemical recurrence, a rise in prostate-specific antigen (PSA) following surgery, which is a measure of longer-term outcomes for aggressive disease. It also reconfirmed the test's ability to predict adverse pathology from the biopsy, as previously demonstrated in a published validation study performed by the University of California, San Francisco (UCSF).
Additional, important endpoints of this landmark prostate cancer study include the development of metastatic disease and outcomes in African-American patients. Genomic Health and CPDR have submitted the results from this study for medical meeting presentation later this year.
"Given the need for more accurate risk stratification of men with newly diagnosed prostate cancer, our prospectively designed and rigorously conducted study provides further validation of the earlier studies at Cleveland Clinic and UCSF showing that the Oncotype DX test is an independent predictor of clinical outcomes in patients with low- and intermediate-risk disease," said Shiv Srivastava, Ph.D., co-director of CPDR who led the evaluation of the Oncotype DX test and its utility as an independent predictor of clinical outcomes under a Cooperative Research and Development Agreement with the Uniformed Services University's (USU) CPDR.
The CPDR is a multi-disciplinary prostate cancer research program of the Department of Surgery, USU, the Department of Defense's federal health sciences university, and it is a collaboration with The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., a private, not-for-profit organization authorized by Congress to support medical research and education at the Uniformed Services University of the Health Sciences.
"In the past year, the growing number of physicians and patients using the Oncotype DX prostate cancer test demonstrates the value it provides to help make the most appropriate choice between immediate treatment or active surveillance," said Phil Febbo, M.D., chief medical officer, Genomic Health. "Once presented, we believe these new results will further increase physician and patient confidence in the Oncotype DX prostate cancer test and allow more men with recently diagnosed prostate cancer to make a better informed treatment decision based upon the biology of their individual cancer."
More than fifty percent of men diagnosed with prostate cancer have low-risk disease with less than a three percent chance of developing advanced, life-threatening disease. However, the large majority currently receive immediate invasive treatment because conventional clinical and pathological evaluations of their needle biopsies do not adequately predict whether aggressive cancer is present in the prostate at time of diagnosis.
Developed and validated in collaboration with Cleveland Clinic and UCSF, the Oncotype DX prostate cancer test addresses the unique challenges in making treatment decisions for men with clinically localized prostate cancer, by identifying patients who can consider active surveillance with greater confidence and thus avoid unnecessary treatment, as well as those men who have more aggressive disease and should consider immediate treatment.
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 screening and surveillance, through diagnosis, treatment selection and monitoring. Genomic Health's lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS). In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of March 31, 2014, more than 19,000 physicians in over 70 countries had ordered more than 440,000 Oncotype DX tests. 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. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits of the company's tests for patients with prostate cancer; limitations of current treatment options; the company's expectations regarding reporting study results; the attributes and focus of the company's product pipeline; the applicability of clinical study results to actual outcomes; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize additional tests in the future. 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 full results of the clinical study; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and expand into new markets domestically and internationally; 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 quarterly report on Form 10-Q for the quarter ended March 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 and Oncotype DX are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
SOURCE Genomic Health, Inc.
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