BioMérieux filed with the FDA for a rapid multiplex vaginitis test designed to detect common causes of vaginitis in about 20 minutes at the point of care. The submission targets both 510(k) clearance and a CLIA waiver pathway for its BioFire SpotFire Vaginitis Panel (VG), supporting use in clinical settings without centralized laboratory turnaround. The assay reports eight results from a single vaginal swab and covers bacterial vaginosis-associated bacterial species, multiple Candida strains, and Trichomonas vaginalis. BioMérieux is targeting women’s and sexual health diagnostics, positioning the panel as a way to guide targeted prescribing during a single visit. If cleared, the test could become a practical companion to outpatient management of vaginitis, where delayed identification often contributes to overtreatment and persistent symptoms.