Gen-Probe Files 510(k) for APTIMA – Analyst Blog

Diagnostic products maker Gen-Probe Inc. (GPRO) has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its APTIMA assay for Trichomoniasis, a sexually transmitted disease. This represents the third of the five regulatory submissions the company plans to complete in the U.S. in 2010. Gen-Probe received the European CE mark for the assay in June 2010. 

 

Trichomonas vaginalis, 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, the 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”. 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 is poised 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.