NEW YORK (GenomeWeb News) – The US Food and Drug Administration has given 510(k) clearance for five additional pathogens for Idaho Technology's FilmArray Respiratory Panel, the company said today.
FDA cleared the FilmArray instrument and the FilmArray panel, a multiplex PCR assay, a year ago for 15 respiratory pathogens. In January, Idaho Tech announced that it was seeking clearance for the five additional pathogens that were cleared today: Bordetella pertussis; Chlamydophila pneumoniae; Mycoplasma pneumoniae; Coronavirus 229E; and Coronavirus OC43.
The FilmArray Respiratory Panel includes the first FDA-cleared assays for eight of the 20 organisms on it, Idaho Tech said. The Salt Lake City-based company added that the FilmArray is the only FDA-cleared panel that can distinguish between certain bacterial and viral respiratory infections. This capability may provide clinical laboratories and doctors with "more comprehensive, actionable information to guide treatment decisions and improve patient outcomes," the company said.
Current additional applications being developed by Idaho Tech for the FilmArray System include a blood culture ID panel, gastrointestinal pathogens panel, and an STD panel. It expects to start clinical testing of its blood culture ID panel later this year.