FDA Approves PROGENSA PCA3 for Prostate Cancer Detection

According to a press release from the manufacturer, Gen-Probe (GPRO) has been given the green light from the US Food and Drug Administration (FDA) for its PROGENSA® PCA3 (Prostate Cancer gene 3) assay.

The approval from the FDA clears the way for sales availability for the first urine-based molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. A major obvious benefit of the PROGENSA screening test is eliminating the need for repeat prostrate biopsies.

“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.