FDA Clears Gen-Probe’s PCA3 Urine Assay for Predicting Need for Repeat Prostate Biopsies

FDA approved Gen-Probe’s Progensa® PCA3 (Prostate Cancer gene 3) assay, which the firm claims is the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. Clearance of the urine-based test in the U.S. was based on data from a 495-patient clinical study, which demonstrated that Progensa PCA3 demonstrated a negative predictive value of 90%.

Gen-Probe acquired exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure in November 2003. The gene is highly over-expressed in prostate cancers and, according to DiagnoCure, can predict the results of repeat biopsies more accurately than traditional serum prostate-specific antigen testing in men who have had at least one negative prostate biopsy. “This is a pivotal achievement for DiagnoCure," comments Yves Fradet, M.D., president and CMO. “We expect it will increase our royalty revenues and will help us keep investing in the development of new and clinically relevant diagnostic tests for cancer.”

FDA clearance of the Progensa PCA3 test covers its use in conjunction with other patient information to aid clinicians in deciding the need for repeat biopsies in men aged 50 years or more who have had one or more previous negative prostate biopsy, and for whom a repeat biopsy would be recommended by a urologist based on current standard of care. The Progensa PCA3 test is already approved in Canada and the EU.