Idaho Technology said today that it has filed a submission with the US Food and Drug Administration for 510(k) clearance of five additional respiratory pathogens for its FilmArray Respiratory Panel.
Approved by the FDA in May 2011, the FilmArray Respiratory Panel is a multiplex PCR-based assay panel designed to simultaneously test nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections (PCR Insider, 5/5/2011).
The FilmArray instrument integrates sample preparation, amplification, detection, and analysis, and is designed to provide results in about an hour with about two minutes of hands-on time, according to the company. FilmArray performs PCR to initially amplify nucleic acids from target pathogens, but its multiplexed detection capabilities are primarily enabled by high-resolution melt curve analysis.
The current version of the FilmArray Respiratory Panel detects nucleic acids from the following viruses: adenovirus, coronavirus HKU1, coronavirus NL63, human metapneumovirus, influenza A, influenza A subtype H1, influenza A subtype H3, influenza A subtype H1 2009, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, rhinovirus/enterovirus and respiratory syncytial virus.
Idaho Tech has submitted the following additional pathogens for approval: Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, coronavirus 229E, and coronavirus OC43. According to the company, there are currently no FDA-cleared assays for these five pathogens.
Idaho Tech said that 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.
"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," CEO Kirk Ririe said in a statement. "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."
Idaho Technology is currently developing additional panels for its FilmArray system including a blood culture ID panel, gastrointestinal pathogen panel, and STD panel. The company said it expects to begin clinical testing on its blood culture ID panel later this year.