NEW YORK (GenomeWeb News) – 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 GenomeWeb Daily News sister publication 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.
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.
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.
A more detailed version of this article can be found on PCR Insider.