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Salt Lake City — BioFire Diagnostics, Inc. has commenced clinical and analytical studies to evaluate the company’s FilmArray Gastrointestinal (GI) Panel, with plans to seek both CE IVD marking and FDA clearance.
The comprehensive 23-target panel tests for common bacteria, viruses and protozoa that cause infectious diarrhea. The test is performed in about an hour directly from stool in transport media.
“With the commencement of our GI studies, we continue to expand our FilmArray clinical diagnostic test menu,” said Kirk Ririe, CEO of BioFire. “We are expecting very encouraging results, and our continued advancement in diagnostic testing is a reflection of BioFire’s passion for creating breakthrough solutions that improve health and advance science.”
BioFire plans to launch the GI panel in the second half of 2014 in both the U.S. and Europe. The GI Panel will be the third clinical diagnostic test to run on the company’s FilmArray system.
The clinical study is being conducted at several hospital-based clinical laboratories in the U.S. and is funded by an NIH R01 grant.