Gen-Probe receives FDA approval for PROGENSA PCA3 assay

Feb 15 2012

DiagnoCure, Inc. (TSX: CUR), a Quebec life sciences company that develops and commercializes high‐value cancer diagnostic tests, announced today that the US Food and Drug Administration (FDA) has approved Gen-Probe's (NASDAQ: GPRO) PROGENSA^® 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.

"We are delighted about this long awaited FDA approval for the PCA3 test, which we believe will greatly improve how physicians decide what interventions to do with men who have had a negative biopsy," stated Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure. "This is a pivotal achievement for DiagnoCure. 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".

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.