Idaho Technology Inc. Seeks FDA Clearance for the Expanded FilmArray® Respiratory Panel
1/31/2012 7:34:27 AM
ALT LAKE CITY--(BUSINESS WIRE)--Idaho Technology, Inc. announced today that it has filed a submission with the U.S. Food and Drug Administration for 510(k) clearance of five additional respiratory pathogens for its FilmArray Respiratory Panel, a user-friendly Multiplex PCR assay currently FDA cleared for 15 respiratory pathogens. The additional five pathogens are: Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Coronavirus 229E, and Coronavirus OC43. There are currently no FDA cleared assays for these five pathogens. The Bordetella pertussis outbreaks in recent months have highlighted the need for an FDA cleared test that can rapidly and accurately distinguish viral infections from more serious bacterial illness.