Gen-Probe has received European CE mark to market its Aptima assay for Trichomonas vaginalis in European Union countries. The test has not been cleared for marketing in the US, but the company has completed its US clinical trial and remains on track to submit a regulatory application later this year.
Gen-Probe’s Aptima Trichomonas assay utilises the same nucleic acid amplification technologies as the Aptima Combo 2 assay for chlamydia and gonorrhea. The studies have shown that Gen-Probe’s Transcription-Mediated Amplification (TMA) technology provides greater sensitivity than existing tests for Trichomonas vaginalis.
In addition, the Aptima Trichomonas assay may be used on the fully automated Tigris system to test the same female specimens as those used with the Aptima Combo 2 assay, which makes testing more convenient for physicians and laboratories.
Angelika Stary, University professor of outpatient center at STD Diagnosis, Vienna, Austria, said: “Trichomoniasis is a common sexually transmitted infection that can lead to serious health consequences in the genital tract if left untreated. The Aptima Trichomonas assay offers clinicians and laboratorians a new method of detection that is significantly more sensitive than current tests.”