Rapid Gastrointestinal PCR Panels Deliver One-Hour Results

Nonspecific symptoms such as diarrhea, vomiting, fever, and abdominal pain complicate organism-specific diagnosis as pathogen populations shift over time. Rapid, broad molecular panels can support timely clinical decisions and infection control, with diarrheal diseases contributing to an estimated 1.7 billion cases globally each year. A new set of gastrointestinal PCR reaction panels has been submitted for U.S. FDA review and now offers one-hour results with enhanced norovirus detection.

bioMérieux has submitted the BIOFIRE FILMARRAY Gastrointestinal 1.1 (GI1.1) Panel and the BIOFIRE FILMARRAY Gastrointestinal 1.1 Panel Mid to the U.S. Food and Drug Administration for 510(k) review. 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. The revisions introduce enhanced norovirus detection to further strengthen assay specificity.

Both panels use multiplex PCR to simultaneously detect gastrointestinal pathogens directly from stool in individuals presenting with signs and/or symptoms of infection. The target menu includes bacteria such as Campylobacter, Salmonella, and Clostridioides difficile; viruses including norovirus GI/GII, adenovirus F40/41, and rotavirus A; and parasites such as Cryptosporidium and Giardia lamblia. The assays run on the BIOFIRE FILMARRAY 2.0 and TORCH systems, require about two minutes of hands-on setup, and have an approximate run time of about one hour.

Regulatory plans include a U.S. FDA 510(k) review for both panels and an intended In Vitro Diagnostic Regulation (IVDR) CE‑marking submission in Europe for the GI1.1 Panel. Commercialization plans call for the GI1.1 Panel to be available across all regions, while the GI1.1 Panel Mid will be initially available in the United States. The updates are positioned to align gastrointestinal syndromic testing with evolving epidemiology and to support timely clinical decision-making and public health response.

“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. Thanks to strong post-market surveillance efforts and work from research and development scientists, we are happy to bring a revised solution, notably to support the accurate identification of norovirus. Gastroenteritis can be serious, and fast identification of the underlying pathogen is critical for infection prevention and control, and optimal patient care,” said Dr. Charles K. Cooper, Executive Vice President, Chief Medical Officer, bioMérieux.

“In a world where infectious disease threats are constantly evolving, diagnostic innovation plays a critical role in strengthening public health systems. As the global leader in gastrointestinal syndromic testing, bioMérieux continues to enhance its molecular offer with the latest generation of the BIOFIRE® FILMARRAY® gastrointestinal panels. These solutions empower clinicians to quickly make informed treatment decisions, limit disease transmission, and improve outcomes for the most vulnerable populations. This strategic investment reinforces our commitment to continuous improvement, supporting healthcare systems to respond more effectively to the challenging landscape of infectious diseases,” stated Jennifer Zinn, Executive Vice President, Clinical Operations, bioMérieux.