The first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy has been approved by the FDA.
In concurrence with other patient information, Gen-Probe’s PROGENSA® PCA3 (Prostate Cancer gene 3) assay is indicated for use in the decision for repeat biopsy in men 50 years of age or older who have had 1 or more negative prostate biopsies. Furthermore, the test is for those patients for whom a repeat biopsy would be the next step based on the current standard of care, before consideration of PROGENSA PCA3 assay results.
“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 Chairman and Chief Executive Officer.
“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.”
Source: Gen-Probe.