Press Releases
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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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24 Sep 2026
Business & Solutions
bioMérieux Launches SPINCHIP® hs-cTnl, a Major Innovation for the Measurement of High-Sensitivity Cardiac Troponin I and Faster Management of Cardiac Emergencies
Marcy-l’Étoile (France), September 24, 2026 – bioMérieux, a global leader in in vitro diagnostics, today announced the launch of SPINCHIP®, an innovative point-of-care platform, featuring its first test for the measurement of high-sensitivity cardiac troponin I from a single drop of blood: SPINCHIP® hs-cTnl. Presented at the European Society of Emergency Medicine (EUSEM) Congress in Paris, this rapid diagnostic solution will initially be available in Europe, bringing a critical test closer to the point of care and helping emergency teams quickly triage adult patients with suspected acute myocardial infarction.
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16 Sep 2026
Business & Solutions
bioMérieux Receives IVDR Class D CE Marking for BIOFIRE® Respiratory 2.1 plus Panel and BIOFIRE® FILMARRAY® Pneumonia plus Panel, the first syndromic tests including MERS-CoV to achieve this certification
bioMérieux, a world leader in the field of in vitro diagnostics, announced that its BIOFIRE® Respiratory 2.1 plus (RP2.1plus) Panel and BIOFIRE® FILMARRAY® Pneumonia plus (PNplus) Panel have received CE marking under the IVDR* as Class D in vitro diagnostic devices, the highest risk classification under the regulation. The classification is driven by the inclusion of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) on both test menus.
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28 Jul 2026
Financial Information
First-Half 2026 Results
bioMérieux's Q2 2026 sales totaled €981 million, with solid organic growth at +5%, reaching +7% excluding BIOFIRE® respiratory panels. The sales of the GO•28 growth drivers increased by 8.5% organically in Q2 26.
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30 Jun 2026
Business & Solutions
bioMérieux submits 510(k) to U.S. FDA for the latest versions of the BIOFIRE® FILMARRAY® Gastrointestinal Panels to enhance detection of gastrointestinal pathogens
bioMérieux, a world leader in the field of in vitro diagnostics, today announces the submission of the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel and the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel Mid to the U.S. Food and Drug Administration (FDA) for 510(k) review. These PCR* molecular panels test 22 and 11, respectively, of the most common bacteria, viruses, and parasites associated with gastroenteritis, all from one sample, with results available in approximately one hour.