Gen-Probe Inc announced today that it has received a European CE mark for its APTIMA® assay for Trichomonas vaginalis, a common parasitic sexually transmitted disease.
Gen-Probe’s APTIMA Trichomonas assay utilizes the same nucleic acid amplification technologies as the APTIMA COMBO 2® assay, the Company’s market-leading test for chlamydia and gonorrhea, and 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.
"Trichomoniasis is a common sexually transmitted infection that can lead to serious health consequences in the genital tract if left untreated," said Dr. Angelika Stary, University Professor, Outpatient Center for STD Diagnosis, Vienna, Austria. "The APTIMA Trichomonas assay offers clinicians and laboratorians a new method of detection that is significantly more sensitive than current tests."
With this CE mark, Gen-Probe is allowed to market the assay in European Union countries. The test has not been cleared for marketing in the United States, but the Company has completed its US clinical trial and remains on track to submit a regulatory application later this year.