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Idaho Technology Seeking FDA Clearance for Additional Pathogens on FilmArray System

NEW YORK (GenomeWeb News) – Idaho Technology said late on Monday that it is seeking US regulatory approval for five additional pathogens for its FilmArray Respiratory Panel.

The company is seeking 510(k) clearance from the US Food and Drug Administration for Bordetella pertiussis; Chlamydophila pneumoniae; Mycoplasma pneumoniae; Coronavirus 229E; and Coronavirus OC43. According to Idaho Technology, no assays are currently cleared by FDA for the five pathogens.

FilmArray, a multiplex PCR assay, was cleared by the agency for 15 other respiratory pathogens last year.

Idaho Technology said that it is developing other applications for the FilmArray system, including a blood culture ID panel, gastrointestinal pathogens panel, and an STD panel, and expects to start clinically testing the blood culture ID panel later this year.