FDA Nod for Gen-Probe's PROGENSA

Diagnostic products maker Gen-Probe Inc. ( ) has secured the approval of the U.S. Food and Drug Administration ("FDA") for its PROGENSA PCA3 assay, a novel molecular test designed to aid the diagnosis of prostate cancer.

The assay is geared for testing urine specimens from men who earlier had a negative prostate biopsy.

Gen-Probe submitted a Pre-market Approval (“PMA”) application to the FDA for PROGENSA PCA3 in September 2010. The California-based company, in November 2011, said that it received a notice from the FDA that stated the regulator had concluded that a panel review was no longer necessary in the review process of the PMA. The panel review was expected in October 2011.

Gen-Probe acquired the exclusive global rights to the PCA3 (a genetic marker for prostate cancer) from Canadian cancer diagnostic tests company DiagnoCure in November 2003. The PROGENSA PCA3 assay, the first urine-based molecular diagnostic assay for prostate cancer, is currently marketed in the European Union and Canada.

Prostate cancer is the second most prevalent cancer (after skin cancer) among American men and the second-leading cause (after lung cancer) of cancer-related death. According to the American Cancer Society (ACS), roughly 241,000 people were diagnosed with prostate cancer in the U.S. in 2011 and around 34,000 of them succumbed to the disease.

The PROGENSA PCA3 assay detects the presence of cell-associated PCA3 in urine. PCA3 is over-expressed in 90% of prostate tumors (quantifiable in urine samples) and predicts biopsy results better than traditional prostate-specific antigen (PSA) testing, as observed in clinical studies. The assay is expected to help reduce unnecessary repeat prostate biopsies in men who have had at least one previous negative biopsy.

Gen-Probe has been a pioneer in the commercial and scientific development of nucleic acid testing (“NAT”) for the diagnosis of infectious diseases. It competes with larger, more established players in the molecular diagnostic industry such as Roche ( RHHBY ) , Becton Dickinson ( BDX - Analyst Report ) , and Abbott Labs ( ABT - Analyst Report ) .

Gen-Probe is a leading pure-play molecular diagnostics company. The company’s molecular diagnostic tests and instruments are designed to improve results and increase laboratory operating efficiency.

Molecular testing enables real-time detection of the primary cause of a disease at the molecular level. Gen-Probe is positioned to benefit from the ongoing market shift away from traditional diagnostic methods (such as antibody-based assays) toward molecular testing, which offers greater precision and sensitivity in detecting biological events.

Gen-Probe’s clinical diagnostics business posted healthy results in the most recent quarter with revenues soaring nearly 13% year over year. The company expects double-digit organic sales and earnings growth in 2012 riding on new product launches (including PROGENSA PCA3). We are currently Neutral on the stock, backed by a short-term Zacks #3 Rank (Hold).