2026-06-30
bioMérieux, a world leader in the field of in vitro diagnostics, has submitted a Dual 510(k)/CLIA Waiver* application to the U.S. Food and Drug Administration (FDA) for the BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel**. This automated, multiplex PCR*** test can simultaneously detect the most common causes of vaginitis in 20 minutes, directly at the point of care. With this submission, bioMérieux is intending to expand into women’s and sexual health, bringing rapid and accurate diagnostics closer to patients.