FDA Approves New Gen-Probe Test for Men at Risk of Prostate Cancer

Xconomy San Diego — 

The FDA has approved a new diagnostic assay for prostate cancer gene 3 (PCA3), according to San Diego’s Gen-Probe (NASDAQ: GPRO), which says the test gives doctors a new diagnostic tool for men who are at higher risk for developing prostate cancer.

The company says the test can help determine if additional prostate biopsies are warranted for men who had negative results from previous prostate biopsies, but who are nevertheless at higher risk for the disease. Gen-Probe says the PCA3 assay gives doctors a new diagnostic tool for addressing concerns that have been raised in recent years about the usefulness of screening men for prostate-specific antigen (PSA), a type of protein that is often elevated in men with prostate cancer and other prostate disorders.

A high PSA level is not a definitive test for determining the presence of cancer, however.

Rather, a prostate biopsy is required. Yet the procedures raise a variety of other issues. Depending on the sample taken, a prostate biopsy could entirely miss a tumor. Such biopsies also are associated with an increased risk for hospital-acquired infections, bleeding, and other complications.

Gen-Probe says its PCA3 test can help resolve this quandary, known as “the PSA dilemma,” because it can detect the presence of the PCA3 gene, a biofactor that the company says is typically over-expressed in 95 percent of prostate cancers.

In its statement, the company quotes John Wei, a professor of urology at the University of Michigan Health System: “Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue,” Wei says. “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.”