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.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval