The new molecular panels are designed to detect up to 22 pathogens in one hour with enhanced norovirus detection.
bioMérieux has submitted 510(k) applications to the Food and Drug Administration (FDA) for the latest versions of its gastrointestinal testing panels. The submission includes the Biofire Filmarray Gastrointestinal 1.1 (GI1.1) Panel and the Biofire Filmarray Gastrointestinal 1.1 (GI1.1) Panel Mid.
These polymerase chain reaction molecular panels are designed to detect the most common bacteria, viruses, and parasites associated with gastroenteritis from a single stool sample. The GI1.1 panel identifies 22 pathogens, while the GI1.1 Mid version identifies 11. Both tests provide results in approximately one hour with about two minutes of hands-on setup time, according to the company.
The new versions include updated capabilities, such as enhanced norovirus detection and increased assay specificity. The panels are intended for use on the Biofire Filmarray 2.0 and Torch systems.
“bioMérieux is continuously seeking opportunities to further advance our existing product portfolio, both to adapt to the evolving needs of patients and clinicians and to respond to emerging changes in epidemiology,” says Charles K Cooper, executive vice president and chief medical officer at bioMérieux, in a release.
Cooper adds that the revised solution supports the accurate identification of norovirus, noting that fast identification of the underlying pathogen is critical for infection prevention, control, and patient care.
Acute infectious gastroenteritis remains a major global health concern, with diarrheal diseases causing an estimated 1.7 billion cases annually worldwide, according to the company. The disease burden is particularly high for young children, older adults, and immunocompromised individuals.
“These solutions empower clinicians to quickly make informed treatment decisions, limit disease transmission, and improve outcomes for the most vulnerable populations,” says Jennifer Zinn, executive vice president of clinical operations at bioMérieux, in a release. “This strategic investment reinforces our commitment to continuous improvement, supporting healthcare systems to respond more effectively to the challenging landscape of infectious diseases.”
The GI1.1 panel is intended for global commercialization, while the GI1.1 Mid panel will initially be available in the US. Following the submission to the FDA, bioMérieux also plans to seek IVDR CE-marking for the GI1.1 panel in Europe.
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