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.

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.

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.

Antimicrobial Resistance

Global Agreement Announced at G7 One Health Summit to Accelerate Access to Diagnostics and Responses to Rising Health Threats

A coalition of more than 20 international partners announced the Global One Health Diagnostics Access Compact (GO-Dx) during the G7 One Health Summit in Lyon, France. This new initiative serves as a catalyst for international leaders across different sectors to advance progress toward expanding diagnostics access, enabling early detection and better surveillance, and improving response against existing and emerging threats across human, animal, and environmental health. By aligning efforts, this group aims to strengthen global preparedness through science based One Health solutions.

Business & Solutions

bioMérieux Receives IVDR CE‑Marking for Two BIOFIRE^® SPOTFIRE^® Panels to Strengthen Near‑Patient Respiratory and Sore Throat Diagnostics Across Europe

bioMérieux, a world leader in the field of in vitro diagnostics, announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel and BIOFIRE® SPOTFIRE® Respiratory/Sore Throat plus (R/STplus) Panel Mini have been CE-marked under the IVDR*. The certification includes conformity assessment for near-patient testing, enabling its use outside traditional laboratories, directly at the point of care.

Financial Information

bioMérieux – 2025 Financial Results

Consolidated sales amounted to €4,070 million in 2025, up 6.2% like-for-like from €3,980 million in the prior year period. Reported growth stood at +2.3% for the period.

Food Safety

bioMérieux launches SMARTBIOME™ to help food manufacturers gain deeper insights into spoilage and protect product quality

bioMérieux, a world leader in the field of in vitro diagnostics, today announces the launch of SMARTBIOME™, an innovative solution designed to help food manufacturers better understand, control and prevent microbiological spoilage. By combining high‑precision DNA sequencing, advanced bioinformatics and bioMérieux’s microbiology expertise, SMARTBIOME™ provides actionable insights to protect product quality, reduce waste and better preserve consumer safety.

Mergers & Acquisitions

bioMérieux Acquires Accellix to Elevate Pharmaceutical Quality Control and Accelerate Advanced Therapies

bioMérieux, a world leader in the field of in vitro diagnostics, announces the acquisition of Accellix, a US company specializing in rapid, automated flow cytometry solutions for cell and gene therapy quality control. With this strategic transaction, bioMérieux strengthens its Pharmaceutical Quality Control activity and invests in innovative solutions that will support the growing advanced therapy market and improve patient outcomes worldwide.

WellStreet Urgent Care, bioMérieux celebrate 200,000 patients served through BIOFIRE® SPOTFIRE® tests in urgent care clinics across Georgia, Ohio and South Carolina

WellStreet Urgent Care and bioMérieux announce the 200,000th patient diagnosed via the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini in their urgent clinics since the first instrument placement in February 2025.

Business & Solutions

bioMérieux launches leading endocrinology testing offer dedicated to enhancing equine health

bioMérieux, a world leader in the field of in vitro diagnostics, today announced the launch of its immunoassay endocrinology offer for equine health, consisting of VIDAS® Equine INSULIN and VIDAS® Equine ACTH.

Business & Solutions

bioMérieux Honored with Multiple 2025 IMV ServiceTrak™ Clinical Laboratory Awards for Diagnostic Excellence

bioMérieux received nine 2025 IMV ServiceTrak™ Clinical Laboratory Awards for excellence in Immunoassay Analyzers, ID/AST Systems, Molecular Diagnostics and Blood Culture Systems.

Business & Solutions

Oxford Nanopore and bioMérieux launch AmPORE-TB, a Research Use Only sequencing-based solution to rapidly characterize drug resistant-tuberculosis

Oxford Nanopore Technologies and bioMérieux have announced the launch of AmPORE-TB, a Research Use Only (RUO) solution for the rapid characterization of mutations associated with antimicrobial resistance in Mycobacterium tuberculosis complex, using Oxford Nanopore sequencing technology.