Idaho Technology said this week that it has initiated a clinical trial to evaluate its FilmArray Blood Culture Identification, or BCID, panel, which is designed to identify more than two dozen sepsis-causing organisms, as well as detect the presence of certain antibiotic resistance genes.
The clinical study is being conducted at several hospital-based clinical laboratories in the US, Idaho Tech said. The company expects the trial to run through the end of this year, and expects to submit a 510(k) application to the US Food and Drug Administration in early 2013.
Pending FDA clearance, Idaho Tech plans to launch the FilmArray BCID panel commercially in the US in the second quarter of 2013. The company also plans to obtain CE IVD marking for the test and launch it in Europe in early 2013.
In parallel with the clinical study, Idaho Tech plans to offer select clinical laboratories limited access to FilmArray BCID as part of an investigational use-only program, the purpose of which will be to familiarize current FilmArray platform users with the investigational BCID panel, Idaho Tech said.
The FilmArray platform 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. The instrument performs PCR to initially amplify nucleic acids from target pathogens, but it uses high-resolution melt curve analysis for multiplexed detection.
FilmArray BCID is designed to provide hospital laboratories with a simple, rapid system to identify infectious microbes immediately following positive blood culture results. It provides 27 different tests for Gram-positive bacteria, Gram-negative bacteria, and fungal pathogens, the majority of which are identified at the species level, the company said.
The panel is designed to correctly identify approximately 90 percent of all microbes commonly found in aerobic blood cultures and to detect the presence of select antibiotic resistance genes.
In May 2011, Idaho Tech received 510(k) clearance from the FDA to market the FilmArray system and its first test, the FilmArray Respiratory Panel, to simultaneously detect 15 respiratory pathogens (PCR Insider, 5/5/2011). In May of this year, the FDA cleared five additional pathogens for the respiratory panel (PCR Insider, 5/17/2012).
Idaho Tech has stated that it is also developing a gastrointestinal pathogen and STD panel for FilmArray.
Initiating clinical studies for the BCID panel "marks an important milestone in the expansion of our FilmArray clinical diagnostic test menu," CEO Kirk Ririe said in a statement. "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 utilization of FilmArray in global markets."