Gen-Probe seeks FDA approval of prostate cancer test Gen-Probe seeks FDA approval of prostate cancer test - SignOnSanDiego.com BY KEITH DARCÉ TUESDAY, SEPTEMBER 21, 2010 AT 2:53 P.M. San Diego medical diagnostics maker Gen-Probe said it submitted a premarket approval application to the Food and Drug Administration for its Progensa PCA3 test, which screens urine samples for a gene tied to prostate cancer. The PCA3 gene is present at abnormally high levels in 90 percent of men with prostate cancer, the company said. The new test is designed for patients who have had a negative biopsy test. A negative PCA3 test result would avoid putting the patient through another biopsy. Gen-Probe President and Chief Executive Officer Carl Hull said the company plans to submit premarket approval applications for two additional tests by the end of the year. PROGENSA® PCA3 Assay Progensa PCA3 Assay, APTIMA HPV Assay, Healthcare-Associated Infections (HCAIs), Nucleic Acid Tests (NATs), Methicillin-Resistant Staphylococcus Aureus (MRSA), Detect Prostate Cancer, Detect Cervical Cancer, Tigris Platform, Panther Platform, Industr PCA3.org - Helping you to decide when prostate biopsy is right In Europe, Gen-Probe's PROGENSA PCA3 assay received marketing clearance in 2006. The assay detects the overexpression of a gene called PCA3 in urine. Studies have shown that PCA3 is highly over-expressed in the vast majority of prostate cancers, indicating that PCA3 may be a useful biomarker for the disease. Preliminary data show that the PCA3 assay is more specific to prostate cancer than the traditional serum prostate specific antigen (PSA) test, thus decreasing the likelihood of false positive results. PSA is produced by both cancerous and non-cancerous prostate cells. Non-cancerous conditions can therefore cause elevated serum PSA levels that must be investigated, resulting in unnecessary medical procedures and patient anxiety. The PROGENSA PCA3 assay remains under development in the United States, and has not been approved for marketing by the FDA.