The FDA has approved the first urine-based molecular test to help determine if men who have had a prior negative prostate biopsy should undergo a repeat biopsy.

The PROGENSA assay, which was developed by Gen-Probe of San Diego, measures prostate cancer antigen 3 (PCA3) in urine. It is indicated for use in conjunction with other patient information in men aged 50 years or older.

The FDA based its approval on a clinical study that began in August 2009 and ended in May 2010. The study enrolled 495 eligible men at 14 clinical sites. In the study, a negative assay result predicted a negative biopsy 90% of the time.

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The study only included men who were recommended for repeat biopsy, so the test’s performance has not been established among men for whom a repeat biopsy was not already recommended.

“Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue,” John Wei, MD, MS, Professor of Urology at the University of Michigan Health System in Ann Arbor, said in a company-issued statement. “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.”