T2 Biosystems received 510(k) clearance from the U.S. Food and Drug Administration for the T2Biothreat Panel. The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market. The T2Biothreat Panel is a direct-from-blood molecular diagnostic test that runs on the FDA-cleared T2Dx Instrument and simultaneously detects six biothreat pathogens, including the organisms that cause anthrax, tularemia, glanders, melioidosis, plague, and typhus. These pathogens have been identified as threats by the U.S. Centers for Disease Control and Prevention and identified as material biological threats under section 319-2(c)(2)(A)(ii) of the Public Health Service Act.
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