Genomic Health, Inc. has announced they have had positive results from a large clinical validation study of a biopsy-based prostate cancer test designed to predict adverse pathology in men with early prostate cancer.
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, could predict adverse pathology for men with early-stage prostate cancer. They are planning on submitting their complete data in a 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.”
“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.”
The company conducted six feasibility and development studies in collaboration with the Cleveland Clinic evaluating more than 700 men 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 decisions based on the underlying biology of an individual patient’s tumor.
If their data holds up, we can anticipate less men being treated unnecessarily, minimizing suffering with unneeded side effect and more men with the potential of developing more aggressive advanced prostate cancer obtaining earlier treatment, hopefully allowing extending their life.
I look forward to seeing their data.
Joel T. Nowak, M.A., M.S.W.