Idaho Technology, Inc., a privately held clinical diagnostics company dedicated to providing the world's fastest, highest-quality instruments for pathogen identification and DNA analysis, today announced it has commenced a clinical trial to evaluate the Company's FilmArray Blood Culture Identification (BCID) Panel, which 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.
Kirk Ririe, Chief Executive Officer of Idaho Technology, states, "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 (IUO) program. The purpose of this program is to familiarize current FilmArray users with the investigational BCID panel.
About FilmArray BCID
FilmArray BCID is designed to provide hospital laboratories with a simple, more rapid system for identifying 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. It is designed to correctly identify approximately 90% of all microbes commonly found in positive aerobic blood cultures. FilmArray BCID also detects the presence of certain antibiotic resistance genes. Rapid identification of a large range of pathogens in blood culture could improve the medical management of sepsis.
About Idaho Technology, Inc.
Idaho Technology, Inc. is a privately held clinical diagnostics company based in Salt Lake City, Utah. Founded in 1990, the Company currently holds over 70 patents related to polymerase chain reaction (PCR), including rapid PCR cycling. The Company has used its extensive patent portfolio to successfully market nearly 200 products to the clinical, research and military markets. The Company manufactures and distributes its proprietary diagnostic respiratory panel, FilmArray RP, which operates on its user-friendly FilmArray system, to hospital-based clinical laboratories in the U.S. and E.U. The Company also collaborates with various U.S. governmental agencies including the Department of Health and Human Services, and the Department of Defense. Among others, researchers, medical technicians, law enforcement officers, and soldiers in the field use company devices to detect or study disease-causing organisms.