Gen-Probe commences clinical study to secure U.S. approval of the PROGENSA PCA3 assay

Aug 28 2009

A new molecular test to help assess prostate cancer risk -

DiagnoCure Inc. (TSX: CUR) announced that Gen-Probe, Inc. (NASDAQ: GPRO), its partner for the development and commercialization of the PCA3 prostate cancer test, has confirmed today the beginning of a U.S. clinical study intended to secure U.S. regulatory approval of the PROGENSA(R) PCA3 assay, a new molecular test that may help determine the need for a repeat prostate biopsy.

Gen-Probe anticipates to enroll 500 men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites. The study is expected to take less than a year, after which, Gen-Probe intends to submit a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration.

"We are excited about the announcement made today by our partner as it represents a decisive step towards maximizing the commercial value of the PCA3 test," stated John C. Schafer, President and Chief Executive Officer of DiagnoCure.

To date, more than 20 peer-reviewed publications support the clinical utility of the PROGENSA PCA3 assay in addressing the well-known limitations of the PSA (Prostate Specific Antigen) test, currently used by urologists, and therefore minimizing the unnecessary, costly and invasive biopsies that follow from "false positive" PSA results.

According to the American Cancer Society and the Canadian Cancer Society, 218,000 men in the United States and Canada will be diagnosed with prostate cancer this year, and more than 32,000 men will die from the disease. Prostate cancer is the second-leading cause of cancer death in men (after lung cancer).