Cepheid, the Danaher-owned molecular diagnostics company, has published results from the first randomized clinical trial evaluating a multiplex molecular test for vaginitis at the point of care. The study found that 89.6% of women tested with the Xpert Xpress MVP panel received appropriate treatment within 24 hours of their clinic visit, compared to 51.9% with standard care.
The findings highlight how poorly current diagnostic practices serve women with vaginal symptoms. The study reported that 25% of providers relied solely on symptoms to guide treatment, and standard approaches correctly identified infections only about 50-63% of the time. Among women with no detectable vaginal pathogens, 50% in the standard care group received unnecessary antimicrobial treatment – compared to 27.1% in the Xpert Xpress MVP group.
“Overuse of antimicrobials when no pathogens are detected should be avoided since it can contribute to antimicrobial resistance, may disrupt the vaginal microbiome, may cause side effects and adds costs to women and their insurers,” the study authors noted.
Xpert Xpress MVP is an FDA-cleared, CLIA-waived PCR test that detects the causative agents of bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis – including co-infections – from a single vaginal swab in approximately one hour. The research was led by investigators at Magee-Womens Research Institute and the University of Pittsburgh and published in Sexually Transmitted Diseases.
“Women presenting with vaginal symptoms deserve accurate answers and timely, evidence-based care,” said Cepheid chief medical officer Dr. Connie Savor. “This study demonstrates how molecular point-of-care tests can help clinicians make more informed treatment decisions in a single visit.”
