BioMérieux submitted a rapid multiplex PCR assay for vaginitis causes to the FDA for dual 510(k) clearance and CLIA waiver. The BioFire SpotFire Vaginitis Panel (VG) is designed to deliver results for common vaginitis pathogens within 20 minutes at the point of care. The submission targets bacterial vaginosis-associated bacterium panels, Lactobacillus species signals, and yeast and parasite detections, including Candida species and Trichomonas vaginalis. BioMérieux said the platform is intended to support same-visit treatment decisions and improve antibiotic stewardship by narrowing likely etiologies. A faster, multiplex format also expands BioMérieux’s footprint in women’s and sexual health diagnostics, where clinicians rely on syndromic approaches and lab turnarounds can delay targeted therapy.