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Idaho Technology, Inc. announced it has commenced a clinical trial to evaluate the company's FilmArray Blood Culture Identification (BCID) Panel. The privately held clinical diagnostics company creates fast, high-quality instruments for pathogen identification and DNA analysis.
The panel is designed to identify the numerous organisms that can cause sepsis, as well as detect the presence of selected antibiotic resistance genes. The study is being conducted at several hospital-based clinical laboratories in the U.S. The FilmArray BCID will be the second clinical diagnostic test to run on Idaho Technology's FilmArray pathogen detection system.
CEO Kirk Ririe said, "Initiating clinical studies for our BCID panel brings us 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. 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."
Idaho Technology anticipates the trial will run through the end of 2012 and expects to submit a 510(k) to the Food & Drug Administration (FDA) in early 2013. Pending FDA clearance, the company intends to launch FilmArray BCID commercially in the U.S. in the second quarter of 2013. The BCID panel will also be CE IVD-marked and offered for sale in the European Union in early 2013.
In parallel with the clinical study, Idaho Technology plans to offer select clinical laboratories limited access to FilmArray BCID as part of an investigational use only program. The purpose of this program is to familiarize current FilmArray users with the investigational BCID panel.