BioMérieux Achieves FDA Clearance for Rapid Vaginitis Diagnostic Panel

bioMérieux announced that it has received Dual 510(k) Clearance and a CLIA Waiver from the FDA for its BIOFIRE® SPOTFIRE® Vaginitis Panel. This molecular diagnostic test detects common causes of vaginitis within approximately 20 minutes. It is designed for use at the point of care, enhancing accessibility and accuracy for patients.

Vaginitis, affecting most women in their lifetime, often suffers from misdiagnosis via traditional methods. This panel provides eight results from a single swab, covering bacterial, yeast, and parasitic pathogens. It supports both self-collected and clinician-collected swabs, facilitating swift treatment decisions during patient visits.

This new addition expands bioMérieux’s portfolio of point-of-care diagnostics and is expected to be available in the U.S. by early 2027.