DiagnoCure Inc. announced that the US Food and Drug Administration (FDA) has approved Gen-Probe's PROGENSA(R) PCA3 (Prostate Cancer Antigen 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. 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, before consideration of PROGENSA PCA3 assay results. A negative PROGENSA PCA3 assay result is associated with a decreased likelihood of a positive biopsy. A prostate biopsy is required to diagnose cancer. The PROGENSA PCA3 assay should not be used for men with atypical small acinar proliferation (ASAP) on their most recent biopsy. Men with ASAP on their most recent biopsy should be treated in accordance with current medical guidelines. The clinical study of the PROGENSA PCA3 assay only included men who were recommended for repeat biopsy. Therefore, the performance of the assay has not been established in men for whom a repeat biopsy was not already recommended. FDA approval of the PROGENSA PCA3 assay was based on a clinical study that began in August 2009 and concluded in May 2010. The study enrolled 495 eligible men at 14 clinical sites. Gen-Probe submitted a Premarket Approval Application (PMA) to the FDA in August 2010.