Gen-Probe announced the FDA has approved its PROGENSA 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.
“Overexpression 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.
FDA approval of the PROGENSA PCA3 assay was based on a clinical study 495 eligible men enrolled at 14 clinical sites that began in August 2009 and concluded in May 2010. In the study, the PROGENSA PCA3 had a negative predictive value of 90%. The 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.
The PROGENSA PCA3 assay should not be used for men with atypical small acinar proliferation on their most recent biopsy. ■