bioMérieux Receives FDA Clearance for its BioFire FilmArray Gastrointestinal Panel Mid

French biotechnology company, bioMérieux, announced today the FDA cleared the its molecular test, the BioFire FilmArray Gastrointestinal (GI) Panel Mid for use in diagnosing gastroenteritis. According to the company, this is a polymerase chain reaction (PCR) testing solution, and can simultaneously detect 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 the BioFire FilmArray Gastrointestinal (GI) Panel, targeting 22 pathogens, available since 2014.

“We target a category of patients with less severe conditions who are currently addressed by slower and less comprehensive diagnostic solutions,” Jennifer Zinn, executive vice president, Clinical Operations, bioMérieux, said in a statement. “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.”

“BioFire FilmArray Gastrointestinal (GI) Panel Mid brings clinicians an additional option in diagnosing infectious gastroenteritis depending on the medical status of patients,” bioMérieux Chief Medical Officer Charles Cooper, MD, said in a statement. “By providing rapid, accurate results, we empower clinicians to make timely, informed decisions, improving patient outcomes and streamlining laboratory workflows.”

The company says its molecular test will be available in the United States at the end of the first half of 2025.

The Impact of Gastroenteritis

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.

Reference

1. bioMérieux receives U.S. FDA clearance for the new version of its molecular test targeting causes of gastroenteritis, BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid. February 11, 2025. Accessed February 11, 2025.
https://www.biomerieux.com/corp/en/journalists/press-releases/fda-clearance-biofire-gastrointestinal-panel-mid.html