bioMérieux announced that they have submitted a Dual 510(k)/CLIA Waiver application to the U.S. Food and Drug Administration (FDA) for the BIOFIRE SPOTFIRE Vaginitis (VG) Panel. The panel represents bioMérieux’s first step into women’s and sexual health testing.

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.

The BIOFIRE SPOTFIRE VG Panel reports 8 results, including bacterial vaginosis, yeast and parasite pathogens, with one swab, in about 20 minutes to align within a typical patient’s visit timeframe. The BIOFIRE SPOTFIRE VG Panel aims to support timely treatment decisions and deliver a clear and dignified diagnostic experience, which may be associated with improved patient management.

Following its submission to the U.S. FDA, the BIOFIRE SPOTFIRE VG Panel is also expected to be submitted as a Class C Near Patient Test for CE marking under the IVDR in the European Union.

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