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Positive Results Reported for Biopsy-Based Prostate Cancer Test

Company plans 2013 commercial launch (Sept. 18)

On September 18, Genomic Health, Inc., based in Redwood City, Calif., announced positive results from a clinical validation study of its biopsy-based prostate cancer test. The study, performed in collaboration with 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 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February.

Based on these results, Genomic Health is completing the necessary work to make the Oncotype DX prostate cancer test available to physicians in the first half of 2013.

The company 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 test was then evaluated in formalin-fixed, paraffin-embedded 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 prostate-specific antigen (PSA), age, and physical examination, the Oncotype DX Genomic Prostate Score will be used to personalize prostate cancer treatment based on the underlying biology of an individual patient's tumor.

Each year, more than 240,000 men are diagnosed with prostate cancer in the U.S. A large percentage of men with low and intermediate-risk disease are over-treated, partly because of the lack of a standardized, validated biopsy-based test to distinguish more accurately between aggressive and clinically indolent tumors.

For more information, visit the Genomic Health Web site.

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