Idaho Technology, a provider of instruments for pathogen identification and DNA analysis, has started clinical trial of its FilmArray blood culture identification (BCID) panel.
The FilmArray BCID panel will run on the company’s FilmArray pathogen detection system to identify infectious microbes, immediately following positive blood culture results, as well as certain antibiotic resistance genes.
The panel also provides 27 different tests for identifying gram-positive or gram-negative bacteria and fungal pathogens at the species level.
The study, which is being conducted at several hospital-based clinical laboratories in the US, is designed to demonstrate the safety and efficacy of FilmArray BCID panel.
Kirk Ririe, Idaho Technology chief executive officer, said initiating clinical studies for the company’s BCID panel brings them another step closer to being able to provide more comprehensive, actionable information which may help guide treatment decisions and improve patient outcomes.
"It also marks an important milestone in the expansion of our FilmArray clinical diagnostic test menu," Ririe added.
"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. We believe the additional menu offering will accelerate adoption and utilisation of FilmArray in global markets."
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 that year.
The company also intends to submit a CE IVD-marked application of FilmArray BCID panel for sale in the European Union in early 2013.