Idaho Technology (ITI) has filed a submission with the US Food and Drug Administration for 510(k) clearance to market its FilmArray Respiratory Panel (RP) as an in-vitro diagnostic product for patients with symptoms of upper respiratory tract infection.
The FilmArray RP is a user-friendly multiplex PCR assay designed for the detection and differentiation of a panel of respiratory viruses and bacteria including adenovirus, bocavirus, corona viruses, human metapneumovirus, influenza A and B viruses, parainfluenza viruses, rhino/entero viruses, respiratory syncytial virus, Bordetella pertussis, and Mycoplasma pneumoniae.
Idaho Technology CEO Kirk Ririe said that the submission to the FDA marks a significant milestone in Idaho Technology’s goal to fill the unmet need for user-friendly multiplex PCR in the hospital clinical laboratory and also said that the company expects rapid adoption of the FilmArray RP partly because of the assay’s ability to detect and differentiate the influenza A H1 2009 virus.
Idaho Technology has several other clinical FilmArray applications currently under development including a GI track panel, a blood culture ID panel and an STD panel.