First urine-based molecular test to help determine need for repeat prostate biopsies

DiagnoCure, Inc., a Quebec life sciences company that develops and commercializes high value cancer diagnostic tests, announced that the US Food and Drug Administration (FDA) has approved Gen-Probe’s PROGENSA® Prostate Cancer Antigen 3 (PCA3) assay. 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. A negative PROGENSA PCA3 assay result is associated with a decreased likelihood of a positive biopsy.