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Genomic Health Announces Positive Topline Clinical Validation Study Results Demonstrating Oncotype DX® Prostate Cancer Test Predicts Risk of Metastasis and Mortality

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...


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