BioFire's FilmArray gastrointestinal panel receives FDA clearance

May 7, 2014

In vitro diagnostics provider bioMérieux has announced that BioFire, its new molecular biology affiliate, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the FilmArray Gastrointestinal (GI) Panel. The 22-target FilmArray GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses, and parasites in one test.

Company representatives note that current diagnostic practice requires choosing among multiple tests that can be laborious to perform and do not cover the breadth of pathogens that cause gastrointestinal illness. Unlike open-platform testing that leaves labs vulnerable to cross contamination, the FilmArray is a closed system that integrates sample preparation, amplification, and detection. In addition, the FilmArray GI Panel is performed directly from stool in Cary Blair transport media, takes only two minutes to set up, and produces results in about an hour.

“The excitement about this panel from the medical community has been astounding” says Randy Rasmussen, bioMérieux Corporate Vice-President Molecular Biology & CEO of BioFire Diagnostics. “We view this panel as a game-changer in the diagnosis of infectious diarrhea, delivering accurate and timely results. The breadth of pathogens on our GI Panel provides physicians with the underlying causes of gastrointestinal infectious disease, which aids with treatment decisions for their patients.”

In the United States, between 200 million and 375 million episodes of diarrheal illness are estimated to occur each year, resulting in 73 million physician visits, 1.8 million hospitalizations, 3,100 deaths, and $6 billion in medical care and lost productivity. Early diagnosis facilitates timely and appropriate therapeutic interventions that can alleviate symptoms and prevent secondary infections. Read more about the FilmArray Gastrointestinal (GI) Panel.

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