Diagnostic products maker Gen-Probe Inc (GPRO) has submitted a 510 (k) application to the U.S. Food and Drug Administration (“FDA”) for the PANTHER system, its fully automated molecular testing platform designed to address a vast spectrum of testing needs. The company received the European CE mark for the instrument in December 2010.
Gen-Probe has developed several assays designed to run on the PANTHER system. These include the company’s market-leading chlamydia and gonorrhea (sexually transmitted infections) test APTIMA COMBO 2. Gen-Probe has filed regulatory application to run APTIMA COMBO 2 assay on the PANTHER system.
The PANTHER system, aimed at low-to-mid volume labs, features a sample-in, sample-out model. It allows an operator to process 275 samples in eight hours, generating 550 chlamydia and gonorrhea results with the APTIMA Combo 2 assay. For larger customers, the PANTHER system can process 500 samples and yield 1,000 results in twelve hours.
The PANTHER system complements Gen-Probe’s TIGRIS system, the first fully automated testing system for molecular diagnostics. It is one of the valuable components of Gen-Probe’s product pipeline. The company believes that PANTHER will significantly contribute to its revenue growth in the years ahead as it broadens the testing menu for the instrument. It will allow Gen-Probe to reinforce its presence in the lab community.
Gen-Probe is a dominant player in the rapidly expanding nucleic acid test (“NAT”) market, the fastest growing segment of the clinical diagnostic market. It is a market leader in domestic gonorrhea and chlamydia testing with its PACE and APTIMA assay product lines. Gen-Probe competes with more established firms in the molecular diagnostic industry such as Roche (RHHBY), Becton, Dickinson (BDX) and Abbott Labs (ABT).
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.
We believe Gen-Probe is well placed with a slew of new products that are expected to be the harbinger of growth in the years ahead. Moreover, the ongoing market shift away from traditional diagnostic methods (such as antibody-based assays) towards molecular testing represents a tailwind for the company. Currently, we are Neutral on the stock.
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