US Food and Drug Administration clears Utah spin-out BioFire's technology.

BioFire, a medical devices spin-out of Utah University, has secured clearance from the US Food and Drug Administration (FDA) for its FilmArray Gastrointestinal Panel.

The device is a gastrointestinal test for a range of pathogens including Ebola and including several pathogens receiving clearance for the first time. The test can be set up in two minutes and analyses stool samples within an hour.

Currently, some 200 million to 375 million cases of gastroenteritis happen each year in the US alone, leading to 73 million trips to the GP, 1.8 million patients being hospitalised and 3,100 patients dying. It costs the US health care system $6bn. Early and quick diagnosis could significantly reduce these numbers.

BioFire has been one of Utah’s spin-out success stories, having been acquired by BioMérieux for $450m in September 2013. It was spun out in 1990 and since grown to close to 500 staff, which have developed 200 products and registered more than 85 patents.

Randy Rasmussen, chief executive at BioFire, said: “The excitement from the medical community about this panel has been astounding. We view this panel as a game-changer in the diagnosis of infectious diarrhoea, delivering accurate and timely results. The breadth of pathogens on our GI Panel provides the big picture in gastrointestinal infectious disease, which will aid clinicians with treatment decisions for their patients.”