Press Releases

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.

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.

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.

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.

bioMérieux introduces Salmonella testing kit on GENE-UP® TYPER to support root cause analysis in the food industry

bioMérieux, a world leader in the field of in vitro diagnostics, today introduces the launch of GENE-UP® TYPER SLM, a new real-time PCR solution supporting rapid root cause analysis by discriminating Salmonella in the food industry environments.

Business & Solutions

bioMérieux invests in France with a new facility to produce innovative diagnostics for the European market

Marcy l’Étoile, France – May 29, 2026 – bioMérieux, a world leader in the field of in vitro diagnostics, announces a strategic investment of more than €250 million to build a new manufacturing facility in France (La Balme-les-Grottes, Isère) dedicated to the production of PCR tests from its BIOFIRE® range. The project is expected to create approximately 400 jobs over time. This new facility will help secure the supply of essential diagnostic solutions for the European market while strengthening the resilience of healthcare systems in the face of infectious diseases.