bioMérieux receives U.S. FDA clearance for the new version of its molecular test targeting causes of gastroenteritis, BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid

Original from: bioMérieux

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid has obtained clearance from the U.S. Food and Drug Administration (FDA). This midplex molecular panel tests for 11 of the most common bacteria, viruses, and parasites associated with gastroenteritis — all from one sample, with results available in approximately one hour.

Acute gastroenteritis, an inflammatory condition of the gastrointestinal tract, is characterized by diarrhea, vomiting, fever, and abdominal pain. This infectious disease can lead to potentially life-threatening health consequences, particularly in children, the elderly, and immunocompromised patients. Globally, diarrheal disease is placed as the third leading cause of death in children under 59 months of age, with approximately 1.7 billion cases of diarrheal disease annually. It presents with many overlapping symptoms that are difficult to distinguish. Furthermore, traditional stool methods can be time-consuming and lack sensitivity, potentially leading to inadequate treatment decisions, unnecessary antibiotic use, inappropriate infection control measures, secondary pathogen transmissions, and suboptimal healthcare resource use.

The newly FDA-cleared BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid, as a polymerase chain reaction (PCR) testing solution, is capable of simultaneously detecting 11 pathogens* directly from stool samples of individuals presenting with signs and/or symptoms of GI infection. Designed for use on bioMérieux’s BIOFIRE® FILMARRAY® 2.0 and Torch PCR platforms, this panel requires about 2 minutes of hands-on time for setup, with an approximate run time of 1 hour.

This new panel complements the bioMérieux’s BIOFIRE® GI offering. It is a variation of the existing highplex BIOFIRE®FILMARRAY® Gastrointestinal (GI) Panel, targeting 22 pathogens, available since 2014, providing laboratories with a streamlined workflow with fast, comprehensive results that increase diagnostic yield, while improving patient outcomes.

“BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid brings clinicians an additional option in diagnosing infectious gastroenteritis depending on the medical status of patients. Our suite of BIOFIRE® FILMARRAY® Gastrointestinal Panels revolutionizes how we approach gastrointestinal diagnostics. By providing rapid, accurate results, we empower clinicians to make timely, informed decisions, improving patient outcomes and streamlining laboratory workflows,”declared Dr. Charles K. Cooper, Executive Vice President, Chief Medical Officer, bioMérieux.

“This new panel broadens bioMérieux’s leadership in syndromic molecular testing for gastrointestinal infections. With BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid, we target a category of patients with less severe conditions who are currently addressed by slower and less comprehensive diagnostic solutions. Now clinicians and laboratories have the opportunity to choose either a 22-target panel or an 11-target one, enabling them to make timely treatment decisions and reduce empirical treatments,” added Jennifer Zinn, Executive Vice President, Clinical Operations, bioMérieux.

BIOFIRE® Gastrointestinal (GI) Panel Mid will be commercially available in the United States at the end of the first half of 2025.

Source: bioMérieux receives U.S. FDA clearance for the new version of its molecular test targeting causes of gastroenteritis, BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid