Research & Development
bioMérieux secures US FDA clearance for new gastrointestinal diagnostic panel
11 February 2025 -

French diagnostics company bioMérieux (Euronext Paris:BIM) announced on Tuesday that it has received US Food and Drug Administration (FDA) clearance for its BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid.

This midplex molecular test detects 11 common bacteria, viruses and parasites associated with gastroenteritis from a single sample, delivering results in approximately one hour.

Acute gastroenteritis is a leading cause of illness worldwide, particularly affecting children, the elderly and immunocompromised patients. Traditional diagnostic methods can be slow and less sensitive, potentially leading to delayed treatment, unnecessary antibiotic use and inefficient infection control measures.

The newly approved panel is designed for bioMérieux's BIOFIRE FILMARRAY 2.0 and Torch PCR platforms, requiring about two minutes of hands-on setup time. It complements the company's highplex BIOFIRE FILMARRAY Gastrointestinal (GI) Panel, which detects 22 pathogens and has been available since 2014.

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid will be available in the United States by mid-2025, offering laboratories a faster and more efficient diagnostic solution.

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