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-
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