Idaho Technology said this week that it has launched a 21-target FilmArray Respiratory Panel in Europe after recently receiving CE in vitro diagnostic marking in the European Union.
In addition, the company said that it has established a distribution partnership with DiaMondial, which will distribute FilmArray RP in "strategic territories in Europe." Idaho Tech did not elaborate on which territories are covered by the arrangement.
Idaho Tech launched FilmArray RP at the European Congress of Clinical Microbiology and Infectious diseases in London.
FilmArray RP is a multiplex PCR-based assay panel designed to simultaneously test nasopharyngeal swabs for 21 respiratory pathogens in about an hour, with approximately two minutes of hands-on time. The platform integrates sample preparation, PCR amplification, and detection via high-resolution melt curve analysis.
A 15-analyte version of FilmArray RP received 510(k) clearance from the US Food and Drug Administration in May 2011 (PCR Insider, 5/5/2011). In January, the company filed a submission with the FDA to clear five additional respiratory pathogen targets (PCR Insider, 2/2/2012).
Idaho Tech said this week that it expects to receive FDA clearance for the expanded panel in the second quarter of this year. The company is also developing a broader test menu for the FilmArray platform, including a blood culture ID panel, gastrointestinal pathogen panel, and sexually transmitted infection panel (PCR Insider, 11/10/2011).