Idaho Technology, a provider of instruments for pathogen identification and DNA analysis, has initiated clinical trial of its FilmArray blood culture identification (BCID) panel.
The FilmArray BCID panel, which will run on the company’s FilmArray pathogen detection system to identify infectious microbes and certain antibiotic resistance genes, is designed to demonstrate the safety and efficacy of FilmArray BCID panel.
The panel also provides 27 different tests for identifying gram-positive, gram-negative bacteria and fungal pathogens at the species level.
Idaho Technology chief executive officer Kirk Ririe said initiating clinical studies for the company’s BCID panel brings another step closer to being able to provide more comprehensive, actionable information which may help guide treatment decisions and improve patient outcomes.
"Many of our existing FilmArray customers have expressed strong interest in using our BCID panel, based on the streamlined workflow and rapid results offered by our system," Ririe added.
The company, which anticipates the trial to run through the end of 2012, expects to submit a 510(k) application of FilmArray BCID to the US Food and Drug Administration in early 2013 and launch in the second quarter of 2013.
The company also intends to submit a CE IVD-marked application of FilmArray BCID panel for sale in the European Union in early 2013.