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Our latest press releases

September 16, 2026

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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July 28, 2026

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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June 30, 2026

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.

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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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