Diagnostic product maker Gen-Probe Inc (GPRO) has received the European CE mark for its APTIMA assay for Trichomonas vaginalis, a sexually transmitted disease. Having achieved this milestone, the company can now market the assay in the European Union for this disease indication.
 
The APTIMA assay is yet to be cleared for marketing in the U.S. for Trichomonas vaginalis. Gen-Probe has completed clinical trials in the U.S. and is expected to submit a 510 (k) application with the U.S. Food and Drug Administration in late 2010.
 
Trichomonas, a sexually transmitted parasite, can cause inflammatory conditions such as vaginitis and urethritis and can make women susceptible to HIV infection. According to the U.S. Centers for Disease Control, Trichomonas infection afflicts roughly 8 million people annually in North America, making it more prevalent than chlamydia and gonorrhea, the most common bacterial sexually transmitted diseases.  
 
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”. Based on the clinical study results, the company’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.
 
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. 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 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. Gen-Probe’s clinical diagnostics business performed strongly in the last quarter with revenues growing nearly 30% year over year.
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