The US Food and Drug Administration (FDA) has cleared Gen-Probe‘s PROGENSA® PCA3 (Prostate Cancer gene 3) assay, the first molecular test to help demonstrate the need for repeat prostate biopsies in men who have had a previous negative biopsy.
The PROGENSA urine-based molecular diagnostic assay is designed to be used along 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 is recommended.
Gen-Probe chairman and CEO Carl Hull said, "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."
"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," Hull added.
University of Michigan Health System urology professor John Wei said, "Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue."
"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," Wei added.
The approval is based on a clinical study that demonstrated that the PROGENSA PCA3 test showed a negative predictive value of 90%, indicating that a negative assay result predicted a negative prostate biopsy 90% of the time.
Earlier data from more than 80 peer-reviewed publications suggested that PCA3 gene testing, when used with other patient information, may help to identify prostate cancers, while reducing unnecessary repeat biopsies.
The PROGENSA PCA3 diagnostic test is now available for sale in the US, Canada and the European Union.
Image: Micrograph of prostatic acinar adenocarcinoma, the most common type of prostate cancer. Photo: Nephron.