Gen-Probe has submitted a Premarket Approval Application (PMA) to the FDA for its PCA3 assay (Progensa), which may help determine the need for repeat prostate biopsies in men suspected of having prostate cancer. Progensa is the first urine-based molecular diagnostic assay for prostate cancer. 

“Based on the results of our U.S. clinical study, data from numerous peer-reviewed publications, and our European commercial experience, we believe the Progensa PCA3 assay can help determine the need for repeat prostate biopsies, thereby improving patient care,” said Carl Hull, Gen-Probe’s president and chief executive officer. 

San Diego-based Gen-Probe is seeking FDA approval to use the assay to test urine samples from men who previously have had a negative prostate biopsy. In support of this objective, the company conducted a prospective, multicenter clinical study of the assay that enrolled 507 men. The trial began in August of 2009 and concluded in May of 2010.  Gen-Probe said it intends to present the results of the study at a future medical meeting.

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PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional PSA testing, according to Gen-Probe.