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Genomic Health Announces Positive Topline Results of Large Prostate Cancer Clinical Validation Study; Company to Proceed with 2013 Commercial Launch
Date:9/18/2012

REDWOOD CITY, Calif., Sept. 18, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results from a large clinical validation study of its biopsy-based prostate cancer test.  The study, performed in collaboration with leading prostate cancer researchers at the University of California, San Francisco (UCSF), met its primary endpoint by demonstrating that the multi-gene Oncotype DX® Genomic Prostate Score (GPS), assessed in prostate needle biopsy tumor tissue, has been prospectively validated as a predictor of adverse pathology for patients with early-stage prostate cancer.  UCSF and Genomic Health plan to submit complete data from this study for presentation at the 2013 ASCO Genitourinary Cancers Symposium in February.  Based on these results, Genomic Health is completing the necessary work in its Clinical Reference Laboratory to make the Oncotype DX prostate cancer test available to physicians and patients in the first half of 2013.

"It is widely recognized that a very large percentage of men with low and intermediate risk prostate cancer are over-treated due in part to the lack of a standardized, validated biopsy-based test to more accurately distinguish between aggressive and clinically indolent disease," said Peter Carroll, M.D., M.P.H., Chair, Department of Urology, University of California, San Francisco. "These results have the potential to change medical practice significantly by providing physicians and their patients with a multi-gene prostate cancer test, designed specifically for biopsies, that will improve treatment decisions for early-stage prostate cancer at the time of diagnosis."

As was the case for the established Oncotype DX breast and colon cancer tests, Genomic Health and its collaborators used a rigorous clinical development strategy for development and validation of the Onc
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SOURCE Genomic Health, Inc.
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