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BioFire Submits GI Panel for 510(k) Clearance

NEW YORK (GenomeWeb News) – BioMérieux subsidiary BioFire Diagnostics said after the close of the market that it has submitted its FilmArray Gastrointestinal Panel to the US Food and Drug Administration for 510(k) clearance.

The panel tests for more than 20 common bacteria, viruses, and parasites that cause infectious diarrhea. A comprehensive 23-target test, FilmArray GI Panel is performed directly from stool in transport media. BioFire said that it anticipates commercial launch of the assay in the early summer of 2014, pending FDA clearance. At the same time, the panel will receive CE marking.

Submission of the assay follows a clinical study that included more than 1,500 prospective samples. The study was conducted at several hospital-based clinical laboratories in the US, BioFire said.

The panel runs on the company's FilmArray molecular diagnostics platform, a closed system that integrates sample preparation, amplification, and detection. The FilmArray GI Panel has a run time of approximately one hour, and hands-on time of two minutes

BioFire pointed out that in the US there are about 76 million cases of foodborne diseases each year, resulting in 325,000 hospitalizations and 5,000 deaths. The Salt Lake City-based firm added that it has begun studies for its meningitis panel and anticipates submitting it to the FDA in 2015.