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Our latest press releases

October 22, 2026

bioMérieux receives Dual 510(k) Clearance and CLIA Waiver from the FDA for the BIOFIRE^® SPOTFIRE^® Vaginitis Panel to Advance Women’s Health with Rapid Molecular Diagnostics

bioMérieux's BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel has received Dual 510(k) Clearance and CLIA Waiver* from the U.S. Food and Drug Administration (FDA).

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October 19, 2026

WHO Grants Emergency Use Listing for BIOFIRE® Global Fever Special Pathogens Panel, Expanding Access to Differential Diagnostics for the Ebola Response

bioMérieux, a world leader in in vitro diagnostics, announced that the World Health Organization (WHO) has granted Emergency Use Listing (EUL) for the BIOFIRE® Global Fever Special Pathogens Panel, strengthening access to differential diagnostic testing in support of the ongoing Ebola Bundibugyo outbreak affecting the Democratic Republic of the Congo (DRC) and neighboring countries.

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June 26, 2026

Advancing Women’s Health with Rapid Diagnostics: bioMérieux files a Dual 510(k) /CLIA Waiver application to the FDA for the BIOFIRE® SPOTFIRE® Vaginitis Panel

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.

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April 23, 2026

First-Quarter 2026 Business Review

bioMérieux, a world leader in the field of in vitro diagnostics, today releases its business review for the three months ended March 31, 2026. Consolidated sales totaled €984 million in the first quarter of 2026.

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