Molecular Panels Gain FDA Clearance for One-Hour Gastrointestinal Pathogen Testing

Acute infectious gastroenteritis, caused by viral, bacterial, and parasitic pathogens, remains a significant global health concern that inflames the gastrointestinal tract. Symptoms such as diarrhea, vomiting, fever, and abdominal pain are often nonspecific, making diagnostic testing critical, particularly for young children, older adults, and immunocompromised individuals. A newly authorized set of molecular panels now enhances detection of gastrointestinal pathogens, including norovirus, from a single sample in about one hour.

bioMérieux has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BioFire FilmArray Gastrointestinal 1.1 (GI1.1) Panel and the BioFire FilmArray Gastrointestinal 1.1 (GI1.1) Panel Mid. The GI1.1 Panel has also obtained CE marking under the European Union In Vitro Diagnostic Regulation (IVDR). The panels test for 22 and 11 of the most common bacteria, viruses, and parasites associated with gastroenteritis, respectively.

Image: The multiplex molecular panels assess 22 and 11 targets, respectively, spanning bacteria, viruses, and parasites from a single stool sample, with results available in approximately one hour (Photo courtesy of bioMérieux)

The PCR molecular panels are designed to detect pathogens directly from stool samples from individuals with signs or symptoms of gastrointestinal infection. The new versions include a redesigned norovirus GI/GII assay and a software-based improvement for Campylobacter detection, strengthening specificity and confidence in results. They are designed for use on the BioFire FilmArray 2.0 and Torch systems, require about two minutes of hands-on setup time, and have an approximate run time of about one hour.

The BioFire FilmArray GI1.1 Panel includes bacterial, viral, and parasitic targets, including Campylobacter, Clostridioides difficile, Salmonella, Norovirus GI/GII, Rotavirus A, Cryptosporidium, and Giardia lamblia. The GI1.1 Panel Mid includes selected bacterial targets, Norovirus GI/GII, and the parasites Cryptosporidium, Cyclospora cayetanensis, and Giardia lamblia. The GI1.1 Panel will be deployed across all regions, while the GI1.1 Panel Mid will initially be available in the United States.

“The regulatory authorizations of these enhanced gastrointestinal panels mark an important milestone in ensuring healthcare providers have access to the most up-to-date diagnostic tools to support patient care. This is particularly important for norovirus, which remains one of the most prevalent and disruptive causes of acute gastroenteritis, and can spread rapidly in communities and healthcare settings. By providing timely and reliable diagnostic information, these panels can help clinicians make informed decisions earlier, support infection control efforts, and ultimately improve the patient experience,” said Dr. Charles K. Cooper, Executive Vice President, Chief Medical Officer, bioMérieux.