FDA Clears Idaho Technology's Flu Tests for JBAIDS

 


 

SALT LAKE CITY, UTAH – (September 28, 2011) Last week, the U.S. Army Office of the Surgeon General received Food and Drug Administration (FDA) clearance of two Influenza test kits for use on the Joint Biological Agent Identification and Diagnostic System (JBAIDS). Idaho Technology, Inc. (ITI), developer and manufacturer of the JBAIDS instrument, performed the optimization and analytical testing of the Center for Disease Control and Prevention-designed influenza assays for work on the JBAIDS. The assays were converted from a traditional wet chemistry to Idaho Technology’s proprietary freeze-dried reagent formulations. This 16-month effort continues ITI’s collaborative efforts with the DoD and other agencies to significantly increase JBAIDS diagnostic capabilities.

The Influenza A/B detection kit identifies Influenza A and B, two viruses that cause seasonal flu. The Influenza A subtyping kit is used detect and differentiate Influenza A subtypes (seasonal H1, seasonal H3 and 2009 H1N1). Both kits identify viral nucleic acids isolated and purified from nasopharyngeal swabs and nasopharyngeal washes from patients with signs and symptoms of respiratory infection.

“It’s very rewarding to see a mature product like the JBAIDS continue to grow in capability. When we designed the system we knew it was capable of so much more than testing for biothreat agents. We look forward to our continued work with DoD on designing and optimizing additional tests for the system,” said Kirk Ririe, chief executive officer of ITI.

The JBAIDS, fielded in 2005, is utilized across all branches of the military for diagnostic testing. Originally designed to identify biological warfare agents, the system’s capability has grown to testing for emerging infectious disease. More than 350 JBAIDS are deployed in DoD laboratories across the world.

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.