FDA approves prostate cancer assay to determine repeat biopsy need

The FDA has approved Gen-Probe’s Progensa PCA3 (Prostate Cancer gene 3) assay to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.

"Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue," John Wei, MD, MS, of the University of Michigan Health System, Ann Arbor, said in a 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."

The 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 assay result is associated with a decreased likelihood of a positive biopsy.

FDA approval of the assay was based on a clinical study that began in August 2009 and concluded in May 2010 and enrolled 495 eligible men at 14 clinical sites. In the study, the Progensa PCA3 had a negative predictive value of 90%, meaning it predicted a negative prostate biopsy 90% of the time.

The clinical study 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.

Dr. Wei was principal investigator on the PCA3 validation study, funded by the National Cancer Institute. He did not receive funding from Gen-Probe.

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