SAN DIEGO, February 15, 2012 /PRNewswire/ --
-- Test May Help Reduce Unnecessary Repeat Prostate Biopsies --
Gen-Probe announced today the US Food and Drug Administration (FDA) has approved its PROGENSA(R) PCA3 (Prostate Cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.
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"When used in conjunction with other diagnostic information, our PROGENSA PCA3 assay provides clinically important information that helps physicians and their patients make better, more informed decisions about one of the most vexing problems in prostate cancer diagnosis," said Carl Hull, Gen-Probe's Chairman and Chief Executive Officer. "From a commercial perspective, this is the third of four potential US regulatory approvals that we expect to generate a significant new sales growth cycle for the Company."
"Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue," said John Wei, MD, MS, Professor of Urology at the University of Michigan Health System. "When evaluated with other risk factors, the PROGENSA PCA3 assay fills an important unmet clinical need by helping physicians identify which men suspected of having prostate cancer should undergo a repeat prostate biopsy."
The PROGENSA PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on the current standard of care, before consideration of PROGENSA PCA3 assay results. A negative PROGENSA PCA3 assay result is associated with a decreased likelihood of a positive biopsy. A prostate biopsy is required to diagnose cancer.
Important Safety Information
The PROGENSA PCA3 assay should not be used for men with atypical small acinar proliferation (ASAP) on their most recent biopsy. Men with ASAP on their most recent biopsy should be treated in accordance with current medical guidelines.
The clinical study of the PROGENSA PCA3 assay only included men who were recommended for repeat biopsy. Therefore, the performance of the assay has not been established in men for whom a repeat biopsy was not already recommended.
FDA approval of the PROGENSA PCA3 assay was based on a clinical study that began in August 2009 and concluded in May 2010. The study enrolled 495 eligible men at 14 clinical sites. Gen-Probe submitted a Premarket Approval Application (PMA) to the FDA in August 2010.
In the clinical study, the PROGENSA PCA3 had a negative predictive value of 90%, meaning that a negative PROGENSA PCA3 assay result predicted a negative prostate biopsy 90% of the time.