RAZOR EX passes Department of Homeland Security sponsored SPADA evaluation
SALT LAKE CITY, UTAH – Idaho Technology, Inc. (ITI) announced that the RAZOR EX BioThreat Detection System was approved and certified as an AOAC Performance Tested SM method for the detection of Bacillus anthracis spores collected by air collection devices onto filter or liquid matrices. The RAZOR EX is the first and only system to successfully pass the rigorous evaluation process. The certification is part of a Department of Homeland Security (DHS) sponsored program with AOAC INTERNATIONAL and the AOAC Stakeholder Panel on Agent Detection Assays (SPADA) to establish a national program for the testing and validation of biosurveillance systems to provide guidance to first responders, public health, and government agencies in procuring equipment.
The extensive validation consisted of three phases: evaluation by the method developer (MD), testing by an independent laboratory (IL) as well as collaborative testing by 12 independent operators. During MD and IL evaluation, 2473 of 2479 samples tested provided expected results (99% success with 95% confidence). “We are proud to have undertaken this extensive evaluation of our RAZOR EX system with our partners at DHS, AOAC and MRIGlobal. The results speak for themselves, the RAZOR EX sets the standard for biothreat detection devices and will continue to be the tool of choice for first responders managing bioterrorism and white powder scenes,” said Todd Ritter, Idaho Technology’s Chief Development Officer. The RAZOR Anthrax System is comprised of a DNA extraction kit, a freeze-dried PCR reagent pouch and the RAZOR EX real-time PCR instrument. Each pouch contains three PCR assays, which distinguish potentially virulent B. anthracis from non-lethal B. anthracis and other Bacillus species. Results from the collaborative study are being analyzed as part of the AOAC Official Methods of AnalysisSM (OMA) program.
A panel comprising over 100 principal stakeholders in biothreat detection including first responders, government agencies, academia, and industry, SPADA was created to develop the criteria for the development, evaluation, and validation of biological threat agent assays and detectors.
About Idaho Technology
Idaho Technology, Inc. is a privately held biotechnology company based in Salt Lake City, Utah. Founded in 1990, Idaho Technology licensed the rapid PCR technology from the University of Utah. Through funds from the United States Department of Health and Human Services and the Department of Defense, the company has created many commercial instruments and reagents for use in research and applied fields. Several of these products, including the LightCycler® Instrument, have been sublicensed to Roche Diagnostics. Researchers, medical technicians, law enforcement officers, and soldiers in the field use the company's devices to detect or study disease-causing organisms. For further information, please visit www.idahotech.com.
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