By IDSE News Staff
The FDA granted marketing clearance to bioMérieux for its Biofire FilmArray Gastrointestinal (GI) Panel Mid, which tests for 11 of the most common bacteria, viruses and parasites associated with gastroenteritis—all from one sample, with results in approximately one hour.
The newly cleared panel is a polymerase chain reaction testing solution that can simultaneously detect 11 pathogens directly from stool samples of individuals presenting with signs and/or symptoms of GI infection.
- Bacteria: Campylobacter jejuni/C. coli/C. upsaliensis, Clostridioides difficile (toxin A/B), Salmonella, Vibrio parahaemlyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2,
- Shigella/Enteroinvasive E. coli (EIEC)
- Viruses: Norovirus GI/GII
- Parasites: Cryptosporidium, Cyclospora cayetanensis, Giarda lamblia
Designed for use on BioMérieux’s Biofire Filmarray 2.0 and Torch PCR platforms, this panel requires about two minutes of hands-on time for setup, with an approximate run time of one hour.
This new panel is a variation of the existing high plex Biofire Filmarray Gastrointestinal (GI) Panel, targeting 22 pathogens, available since 2014, providing laboratories with a streamlined workflow with fast, comprehensive results that increase diagnostic yield, while improving patient outcomes (BMC Gastroenterol 2020;20[1]:246).
Acute gastroenteritis, an inflammatory condition of the GI tract, is characterized by diarrhea, vomiting, fever and abdominal pain. This infectious disease can lead to potentially life-threatening consequences, particularly in children, elderly people and immunocompromised patients. Globally, diarrheal disease is the third-leading cause of death in children under 59 months of age, with approximately 1.7 billion cases of diarrheal disease annually, according to the WHO.
The infection presents with many overlapping symptoms that are difficult to distinguish. Furthermore, traditional stool testing methods can be time-consuming and lack sensitivity, potentially leading to inadequate treatment decisions, unnecessary antibiotic use, inappropriate infection control measures, secondary pathogen transmissions and suboptimal healthcare resource use.
The panel “brings clinicians an additional option in diagnosing infectious gastroenteritis depending on the medical status of patients,” said Charles K. Cooper, MD, the executive vice president and chief medical officer at BioMérieux. “Our suite of Biofire Filmarray gastrointestinal panels revolutionizes how we approach gastrointestinal diagnostics. By providing rapid, accurate results, we empower clinicians to make timely, informed decisions, improving patient outcomes and streamlining laboratory workflows.” .
The new panel will be commercially available in the United States at the end of the first half of this year.
