What to know about bioMérieux’s BIOFIRE SPOTFIRE Vaginitis Panel, recently Dual FDA-cleared and CLIA waived
bioMérieux’s BIOFIRE SPOTFIRE Vaginitis Panel received FDA 510(k) clearance and a CLIA waiver, enabling rapid detection of eight causes of vaginitis in 20 minutes.
bioMérieux’s BIOFIRE SPOTFIRE Vaginitis Panel has been granted Dual 510(k) Clearance and CLIA Waiver from the U.S. Food and Drug Administration (FDA), the company announced on October 22.
What does the test detect? The BIOFIRE SPOTFIRE Vaginitis Panel detects eight common causes of vaginitis.
What do laboratories need to know about the test? It’s rapid, molecular, and automated. It can be administered at the point-of-care.
Does the test support self-collection? Yes. Healthcare professionals and patients have the option to use a self-collected swab or a clinician-collected swab.
How long does it take for patients to receive results? Results are available during the patient’s visit, in 20 minutes.
When will the test be available in healthcare settings? bioMérieux expects a commercial release in early 2027 in the United States. It will be rolled out worldwide shortly after.
