Idaho Technology submits FilmArray Respiratory Panel for FDA 510(k) clearance

Jan 30 2012

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.

Kirk Ririe, CEO, said, "We have been quite pleased with how well the FilmArray system has been received by the clinical laboratory community and by how quickly it is being adopted. We are very excited about the potential addition of these five respiratory pathogens - particularly the bacterial targets. Many of our potential and current hospital laboratory customers are eagerly anticipating the launch of the expanded FilmArray Respiratory Panel."

A respiratory tract infection can be caused by one of dozens of viral or bacterial pathogens. While the symptoms caused by these pathogens are nearly indistinguishable, how a healthcare provider chooses to treat a respiratory infection may depend greatly on a rapid and accurate diagnosis of the responsible pathogen. The FilmArray RP is designed to aid healthcare providers in making this diagnosis.

Idaho Technology is currently developing additional applications for its FilmArray system including a blood culture ID panel, gastrointestinal pathogens panel, and an STD panel. The company expects to begin clinical testing its blood culture ID panel later this year.