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22 Oct 2026
Press Release
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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19 Oct 2026
Others
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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26 Jun 2026
Business & Solutions
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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23 Apr 2026
Financial Information
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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20 Apr 2026
Sepsis
First-of-its-Kind Health Economic Analysis Shows Early Use of Fast Diagnostics in Sepsis Care Could Save Thousands of Lives and Reduce Health System Costs Across G7 Countries
bioMérieux, a world leader in in vitro diagnostics, announces the publication of a multi-country health economic analysis assessing the impact of deploying fast identification and antimicrobial susceptibility testing (ID/AST) early in the care pathway for patients with bloodstream infections at high-risk of sepsis.
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09 Apr 2026
Pharma Quality Control
bioMérieux Unveils its BIOFIRE® SPOTFIRE® Molecular Testing Solution for the Pharmaceutical Industry, Redefining Rapid Mycoplasma Testing
bioMérieux, a world leader in the field of in vitro diagnostics, announces the launch of BIOFIRE® SPOTFIRE® for pharmaceutical industries, where this innovative molecular testing system is designed to transform quality control. Building on the proven success of the BIOFIRE® FILMARRAY® platform, already adopted by leading global pharmaceutical companies, BIOFIRE® SPOTFIRE® introduces a simple, small and smart approach to mycoplasma detection, helping biopharmaceutical manufacturers strengthen quality control, accelerate decision-making, and protect patients.