GPRO GoPro Inc

Diagnostic products maker Gen-Probe Inc (GPRO) has won the approval of the U.S. Food and Drug Administration (“FDA”) for its APTIMA assay for Trichomonas vaginalis, a sexually transmitted disease. The California-based company filed the 510 (k) application for the assay with the regulator in October 2010. The APTIMA Trichomonas assay was cleared in Europe in June 2010.  

Trichomonas, a sexually transmitted parasite, can cause inflammatory conditions such as vaginitis and urethritis and can make women susceptible to the HIV infection. According to the U.S. Centers for Disease Control, Trichomonas infection afflicts roughly 7.4 million people annually in North America, making it more prevalent than chlamydia and gonorrhea, the most common sexually transmitted bacterial infections.  

Currently, screening for Trichomonas is limited, in part, due to the shortcomings of the existing testing methods such as culture and wet mount microscopy (microscopic examination of a sample). These traditional techniques are slow and less sensitive vis-à-vis molecular tests.  

The APTIMA Trichomonas assay leverages the same nucleic acid amplification technologies as Gen-Probe’s market leading chlamydia and gonorrhea test APTIMA COMBO 2 assay. It is the first approved amplified nucleic acid test (“NAT”) to specifically detect Trichomonas vaginalis. Based on the clinical study results, Gen-Probe’s amplification technology offers greater sensitivity than the current test techniques.

Moreover, the APTIMA Trichomonas assay can be used with Gen-Probe’s TIGRIS system, the only fully automated testing system for molecular diagnostics, to test the same samples used with APTIMA COMBO 2. This will offer a convenient way for physicians and laboratories to provide fast and accurate detection of infectious diseases.

Gen-Probe is a dominant player in the rapidly expanding 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).

Gen-Probe has a strong pipeline of novel assay products that are expected to drive future growth. Moreover, the ongoing market shift away from traditional diagnostic methods towards molecular testing represents a tailwind for the company. Currently, we have a Neutral recommendation on Gen-Probe.

 
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