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FDA Clears Flu Tests for Use on Idaho Tech's JBAIDS

NEW YORK (GenomeWeb News) – The US Food and Drug Administration last week cleared two molecular diagnostic flu tests for use on the Joint Biological Agent Identification and Diagnostics System, Idaho Technology, the developer of the system, said on Wednesday.

The Influenza A/B detection kit identifies influenza A and B. The influenza A subtyping kit is for detecting and differentiating influenza A subtypes, such as seasonal H1, seasonal H3, and 2009 H1N1. Both kits identify viral nucleic acids isolated and purified from nasopharyngeal swabs and washes from patients with respiratory infection symptoms.

Idaho Technology optimized and performed analytical testing of the assays that were designed for the Centers for Disease Control and Prevention for use on JBAIDS. The assays were converted to Idaho Technology's freeze-dried reagent formulations from traditional wet chemistry, an effort that took 16 months, the company said.

JBAIDS was originally developed for the identification of biological warfare agents but has been built out as a testing platform for infectious diseases. More than 350 systems are currently installed in US Department of Defense laboratories worldwide, Idaho Technology said.

During the spring, FDA cleared the company's molecular diagnostic test for Q fever infection for use on JBAIDS.

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