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FDA Clears Idaho Technology's Biothreat Tests

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared two pathogen-detection kits, including one for tularemia and one for a plague, made by Idaho Technology, the company said today.
The tests will run on the company’s Joint Biological Agent Identification and Diagnostic System, which was selected by the US Department of Defense in 2003 for biothreat detection, ITI said. These tests can use blood, sputum, positive blood cultures, and colonies and can generate results in under four hours.
The cleared kits identify Yersinia pestis and Francisella tularensis, both of which are classified as Category A Select Agents by the Centers for Disease Control and Prevention, which means they are considered high-priority biothreats to national security.
The clinical trials for the JBAIDS Plague and the JBAIDS Tularemia detection kits were conducted by the Army, Navy, and Air Force, the company said.
The company also plans to seek FDA clearance for its JBAIDS Brucellosis Detection Kit, ITI added.

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