Pretty familiar w/ biotechs that produce drugs and the pre-clinical to phase three to approval process.
I also know that medical devices, such as ISRG's went through a different FDA process than drugs. Can any of you clarify for me the main steps to what I assume is a FDA approval for tests? Prostate cancer market seems huge, love the Baker Brothers, but couldn't really understand clinical trials, phases, approval from their website.
The procedures the FDA looks for with diagnostics is much different than the Phase 1 2 3 NDA etc for a drug.For the sake of this board - ; - ) look on the FDA site. "trials are replaced with data that is "peer reviewed" (Academia) .The process helps the FDA sort ot the Commercialism of some bios.What makes Genomic Health the class act ,is that they almost furnish "drug trial" dat to insure the decision quickly ,,,as they did on prostate Best ! Terry
Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results from a large clinical validation study of its biopsy-based prostate cancer test. The study, performed in collaboration with leading 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 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."
As was the case for the established Oncotype DX breast and colon cancer tests, Genomic Health and its collaborators used a rigorous clinical development strategy for development and validation of the Oncotype 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 tests, combined with our established global infrastructure, we believe Genomic Health is well positioned to deliver this critical tool to physicians and prostate cancer patients around the world."