Press Releases

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.

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.

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.