NEW YORK – BioMérieux announced Tuesday that the US Food and Drug Administration has cleared its 11-target gastrointestinal PCR panel on the BioFire FilmArray 2.0 and high-throughput Torch platforms.
Diarrheal diseases impact nearly 2 billion people globally per year and are the third-leading cause of death among children under 5 years of age, yet they can be difficult to differentiate using time-consuming traditional testing.
The Gastrointestinal (GI) Panel Mid tests directly from stool for bacteria, viruses, and parasites that most commonly cause gastroenteritis using a single sample, with results in one hour with approximately two minutes of hands-on time.
"This new panel broadens BioMérieux’s leadership in syndromic molecular testing for gastrointestinal infections," said Jennifer Zinn, executive VP of clinical operations at BioMérieux. With the panel, "we target a category of patients with less severe conditions who are currently addressed by slower and less comprehensive diagnostic solutions," Zinn said, adding, "Now clinicians and laboratories have the opportunity to choose either a 22-target panel or an 11-target one, enabling them to make timely treatment decisions and reduce empirical treatments."
BioMérieux's high-plex FilmArray panel was cleared in 2014, following the firm's acquisition of BioFire.
For bacterial targets, the mid-plex panel detects three species of Campylobacter in a single target, specifically C. jejuni, C. coli, and C. upsaliensis, three strains of Vibrio, specifically V. parahaemlyticus, V. vulnificus, and V. cholerae, Clostridioides difficile toxin A/B, Salmonella, Yersinia enterocolitica, Shiga-like toxin producing E. coli (STEC) stx1/stx2, and Shigella/Enteroinvasive E. coli (EIEC). Its viral target is norovirus, while its parasitic targets are Cryptosporidium, Cyclospora cayetanensis, and Giarda lamblia.
The mid-plex panel, "brings clinicians an additional option in diagnosing infectious gastroenteritis, depending on the medical status of patients," said Charles Cooper, BioMérieux's executive VP and chief medical officer. "By providing rapid, accurate results, we empower clinicians to make timely, informed decisions, improving patient outcomes and streamlining laboratory workflows."
BioMérieux said that as of Dec. 31, 2024, the number of FilmArray systems installed globally reached 26,750 units. The BioFire GI Panel Mid will be available commercially in the US at the end of the first half of 2025.