To advance development of the FilmArray system and pursue CLIA waiver effort
The Defense Threat Agency (DTRA), on behalf of the US Air Force Assistant Surgeon General, Modernisation Directorate (AF/SGR), has awarded Idaho Technology, a $3.3m to advance development of the FilmArray system and pursue Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA.
The company said that CLIA waiver applies to tests that are simple to perform and interpret, such as rapid Strep tests and pregnancy tests, and can be used in virtually any laboratory setting by non-technically trained operators
The FilmArray integrates sample preparation, Polymerase Chain Reaction (PCR) amplification, detection and analysis into one easy-to-use system capable of detecting greater than 100 targets in one sample in less than an hour.
Kirk Ririe, chief executive of Idaho Technology, said: “The FilmArray system’s ability to test for common and emerging respiratory pathogens with sample to result in one-hour, will provide the military a near real-time force protection capability.”
Reportedly, on March 16, 2009, Johns Hopkins University Applied Physics Laboratory has completed a quantitative assessment on existing devices, the current state of biodetection technologies/instrument systems and the technologies that most closely align with AF/SGR Epidemic Outbreak Surveillance (EOS), Advanced Concept Technology Demonstration (ACTD) objectives.
The results of this study concluded that Idaho Technology’s FilmArray technology meet current DoD and EOS ACTD needs. A total of 164 instrument systems were scored as part of this technology survey, and more than 200 instruments, from over 100 companies, were researched.