The U.S. Food and Drug Administration (FDA) has cleared bioMérieux's BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid, a molecular diagnostic test that can simultaneously detect 11 common pathogens associated with gastroenteritis from a single stool sample in approximately 1 hour.

Traditional diagnostic methods for gastroenteritis can be time-consuming and may lack sensitivity, potentially leading to suboptimal treatment decisions and unnecessary antibiotic use. The newly cleared panel, which requires only 2 minutes of hands-on setup time, tests for specific bacteria, viruses, and parasites that cause GI infections.

The panel is designed for use in patients presenting with signs and/or symptoms of GI infection, including populations such as children, elderly individuals, and immunocompromised patients, for whom gastroenteritis can lead to potentially life-threatening health consequences, according to bioMérieux. This development is particularly significant given that diarrheal disease ranks as the third leading cause of death in children younger than 59 months globally, with an estimated 1.7 billion cases occurring annually.

"Our suite of BIOFIRE FILMARRAY [GI] Panels revolutionizes how we approach GI diagnostics. By providing rapid, accurate results, we empower clinicians to make timely, informed decisions, improving patient outcomes and streamlining laboratory workflows," said Charles K. Cooper, MD, Executive Vice President and Chief Medical Officer at bioMérieux, in a company press release.

The panel detects seven bacterial pathogens, including Campylobacter, Clostridioides difficile, and Salmonella; one viral pathogen (Norovirus GI/GII); and three parasitic pathogens. It complements bioMérieux's existing 22-pathogen panel, offering clinicians a streamlined option for patients with less severe conditions.

Jennifer Zinn, Executive Vice President of Clinical Operations at bioMérieux, emphasized that the new panel "target[s] a category of patients with less severe conditions who are currently addressed by slower and less comprehensive diagnostic solutions."

The test runs on bioMérieux's BIOFIRE FILMARRAY 2.0 and Torch polymerase chain reaction platforms. The BIOFIRE GI Panel Mid will become commercially available in the United States by the end of the first half of 2025. 

Reference:

bioMérieux. bioMérieux Receives FDA Clearance for BIOFIRE® Gastrointestinal Panel (GIP) Mid. bioMérieux. https://www.biomerieux.com/us/en/journalists/press-releases/fda-clearance-biofire-gastrointestinal-panel-mid.html