By Ben Butkus
Idaho Technology said today that it has received 510(k) clearance from the US Food and Drug Administration to market its FilmArray instrument and FilmArray Respiratory Panel, a multiplex nucleic acid test designed to simultaneously detect 15 respiratory viruses.
The FDA in February approved an earlier version of the FilmArray Respiratory Panel, or RP. However, last week Wade Stevenson, diagnostic product manager at Idaho Tech, told PCR Insider that Idaho Tech chose not to commercialize that product, instead submitting to FDA an updated version of the panel including two additional viral targets, the parainfluenza 1 and 2 viruses. Stevenson also said that Idaho Tech was expecting approval for the new product within a week (PCR Insider, 4/28/11).
The most recently approved version 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.
According to Idaho Tech's website, FilmArray RP is also capable of detecting three bacterial targets: Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. However, Stevenson told PCR Insider this week that FDA did not approve these targets in either version of the panel, and that the company is still developing the bacterial targets and hopes to include them in a future version of FilmArray RP.
FilmArray RP is a multiplex PCR-based assay panel designed to simultaneously test nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. 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.
While FilmArray performs PCR to initially amplify nucleic acids from target pathogens, its multiplexed detection capabilities are primarily enabled by high-resolution melt curve analysis, a method that can "qualitatively pick up PCR products for diagnostic purposes that qPCR can't," Idaho Tech co-founder Carl Wittwer said at a scientific conference last week.
Last January, the company initiated clinical trials for FilmArray RP at University of Texas Southwestern Medical Center, Detroit Medical Center, and the Medical University of South Carolina (PCR Insider, 1/28/2010). Idaho Tech initially filed for 510(k) clearance in November (PCR Insider, 11/4/2010).
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