T2 Biosystems, Inc. announced the initiation of a U.S. clinical trial evaluating the performance of its T2Biothreat® Panel designed to support a submission to the U.S. Food and Drug Administration (FDA). The T2Biothreat® Panel, which runs on T2 Biosystems' T2Dx® Instrument, is a direct-from-blood test panel that provides results in 3-5 hours and simultaneously detects six biothreat pathogens identified as threats by the U.S. Government, including B. anthracis, F. tularensis, Burkholderia spp., Y. pestis, and R. prowazekii. The Company plans to file the FDA submission for the T2Biothreat® Panel in 2022 following completion of the clinical trial, which includes positive samples being prepared and analyzed at a high-containment Biosafety Level 3 laboratory and negative samples being analyzed at a single site, and is estimated to cost T2 Biosystems $400,000 - $500,000.
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