Diagnostic products maker Gen-Probe Inc. (GPRO: 69.43 +0.61 +0.89%) has submitted a Pre-market Approval (PMA) application to 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. Gen-Probe is seeking FDA approval to use the assay to test urine specimens from men who earlier had a negative prostate biopsy.
This represents the second of the four PMA submissions that Gen-Probe plans to complete in 2010. The FDA has formally accepted the PROGENSA PMA and has advised Gen-Probe that a meeting (timeline unspecified) of the Medical Devices Advisory Committee’s Immunology Panel will be necessary to support approval of the filling.
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 (launched in 2006) in the European Union.
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 218,000 people are expected to be diagnosed with prostate cancer in the U.S. in 2010 and 32,000 would succumb 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.
California-based Gen-Probe has been a pioneer in the commercial and scientific development of nucleic acid testing (NAT) for the diagnosis of infectious diseases. It is a market leader in domestic gonorrhea and chlamydia testing with its PACE and APTIMA assay product lines.
established players in the molecular diagnostic industry such as Roche (RHHBY: 0.00 N/A N/A), Becton Dickinson (BDX: 83.45+1.64 +2.00%), and Abbott Labs (ABT: 51.90 +0.90 +1.76%).
Molecular testing enables real-time detection of the primary cause of a disease at the molecular level. The global market for molecular diagnostic tests currently exceeds $3 billion and is forecasted to reach roughly $5 billion by 2011. 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.
| Analysts' Targets | |
| Barclays Capital | $70 |
| Overweight | |
| Monday, April 11, 2011 | |
| Oppenheimer & Co. Inc. | $71 |
| Perform | |
| Thursday, March 17, 2011 | |
| RBC Capital Markets | $58 |
| Sector Perform | |
| Friday, January 14, 2011 | |
| Robert W. Baird & Co. | $59 |
| Hold | |
| Tuesday, November 16, 2010 | |
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