Diagnostic products maker Gen-Probe (GPRO) has secured the license of Health Canada for its PANTHER system, a fully automated molecular testing platform designed to address a vast spectrum of testing needs. This represents a major landmark in the California-based company’s endeavor to make this breakthrough product available to the global lab community.
The PANTHER system complements Gen-Probe’s TIGRIS system, the first fully automated testing system for molecular diagnostics. The company has developed several assays designed to run on the PANTHER system including its market-leading chlamydia and gonorrhea test APTIMA COMBO 2.
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.
Gen-Probe 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 the company to reinforce its presence in the lab community.
Gen-Probe, in May 2011, submitted a 510 (k) application to the U.S. Food and Drug Administration (“FDA”) for the PANTHER system. The company received the European CE mark for the instrument in December 2010.
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).
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. However, the company’s struggling blood screening business is expected to remain under pressure due to lower instrument sales to partner Novartis (NVS). Currently, we are Neutral on the stock.
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