NEW YORK (GenomeWeb News) – Idaho Technology has filed for US Food and Drug Administration clearance of its FilmArray Respiratory Panel as an in vitro diagnostic product for patients with symptoms of upper respiratory tract infection.
The FilmArray RP is a multiplex PCR-based assay designed to detect and differentiate 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.
"Several hospitals have expressed a strong interest in the FilmArray RP and many have already placed orders for it or are currently evaluating the system," Idaho Technology CEO Kirk Ririe said in a statement.
He also said that the firm expects "rapid and significant adoption" of the FilmArray RP partly because of its ability to detect and differentiate the novel influenza A H1 2009 virus.
Salt Lake City-based Idaho said that it is developing other FilmArray tests including a GI track panel, a blood culture ID panel, and an STD panel.