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Genomic Health Announces Initiation of Clinical Validation Study of Prostate Cancer Test; Acceleration of Next Generation Sequencing Program
Date:1/9/2012

REDWOOD CITY, Calif., Jan. 9, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that it has started a large clinical validation study of its prostate cancer test.  The study, being performed in collaboration with leading prostate cancer researchers at the University of California, San Francisco (UCSF), is designed to determine if a multi-gene test can help distinguish aggressive disease requiring surgery from less aggressive disease that may undergo active surveillance in patients with early-stage prostate cancer. The study will utilize Genomic Health's proprietary RT-PCR process for analyzing very small amounts of formalin-fixed paraffin-embedded (FFPE) prostate tissue obtained by needle biopsy prior to removal of the prostate. Complete results are expected to be presented at the end of this year or early next year, and if positive, are expected to support the launch of the Oncotype DX® prostate cancer test in 2013.

"Moving our prostate cancer test into the final stage of clinical validation, combined with the recent successful launch of our Oncotype DX DCIS Score and MMR colon cancer testing service, reflects our ability to deliver better outcomes for cancer patients," said Kim Popovits, President and Chief Executive Officer, Genomic Health.  "Once validated, we believe the Oncotype DX prostate cancer test will provide physicians and prostate cancer patients with much needed information for making treatment decisions, similar to what our tests for breast and colon cancer do today."

The company also announced that it is accelerating its Next Generation Sequencing (NGS) program by moving it into clinical development studies that will examine both RNA-Seq expression and mutation analysis. This decision comes after the company successfully conducted the first clinical outcomes study for biomarker discovery u
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SOURCE Genomic Health, Inc.
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