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FDA Clears Quidel's Trichomonas Assay

NEW YORK (GenomeWeb) – Quidel today announced that the US Food and Drug Administration has cleared the company's AmpliVue Trichomonas Assay for marketing. 

The assay detects nucleic acids isolated from vaginal swab specimens obtained by clinicians from symptomatic and asymptomatic female patients. It runs on Quidel's AmpliVue handheld molecular diagnostic device and does not require upfront DNA extraction. Quidel said the assay generates results in about 50 minutes. 

The trichomonas assay is the sixth to be cleared by the FDA for the AmpliVue device, following earlier clearances for Clostridium difficile, Group A Streptococcus, Group B Streptococcus, Bordetella pertussis, and herpes simplex viruses 1 and 2. 

Citing statistics from the US Centers for Disease Control and Prevention, Quidel said about 3.7 million people in the US have trichomoniasis, the sexually transmitted disease attributable to infection by the Trichomonas vaginalis parasite. 

"We believe that our test will play a critical role in quickly diagnosing this disease, creating opportunities for patient treatment and thereby limiting its spread," Quidel President and CEO Douglas Bryant said in a statement. 

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