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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

otype DX Genomic Prostate Score.  In a three year effort, Genomic Health optimized its proprietary RT-PCR methodology to be able to analyze the very small amounts of formalin-fixed paraffin-embedded prostate tissue obtained by diagnostic prostate needle biopsies.

"The over-treatment of prostate cancer represents one of the most significant issues in men's health today," said Howard Soule, Executive Vice President and Chief Science Officer of the Prostate Cancer Foundation. "With this study, Genomic Health has applied its groundbreaking technology and innovative clinical trial expertise to address a critical treatment decision facing hundreds of thousands of men each year."

Genomic Health conducted six feasibility and development studies in collaboration with the Cleveland Clinic evaluating more than 700 patients and 700 candidate genes to select the genes for this test.  The resulting pre-specified test was then evaluated in prostate needle biopsy specimens in the prospectively-designed UCSF clinical validation study.  It is expected that in conjunction with the Gleason grading system and conventional parameters such as PSA, age, and physical examination, the Oncotype DX Genomic Prostate Score will be utilized to personalize prostate cancer treatment based on the underlying biology of an individual patient's tumor.

"Each year in the U.S. alone, more than 240,000 men are diagnosed with prostate cancer, with the vast majority receiving aggressive treatments associated with serious, long-term side effects.  Based on the results of this study, we believe the Oncotype DX Genomic Prostate Score will increase the number of patients eligible for active surveillance, and identify those who should consider aggressive treatment," said Steven Shak, Executive Vice President of Research and Development and Chief Medical Officer at Genomic Health.  "With our proven record of developing and validating multi-gene t
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SOURCE Genomic Health, Inc.
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