TTOO - T2 Biosystems applies for FDA Breakthrough Device designation for its T2Biothreat Panel
T2 Biosystems (NASDAQ:TTOO) on Wednesday said it had applied for a Breakthrough Device designation from the U.S. FDA for its T2Biothreat Panel product. TTOO stock +5.1% to $0.42 in premarket trade. The FDA's Breakthrough Device program aims to speed up the development and access to medical devices that have the potential to offer more effective treatment for life-threatening diseases. TTOO's T2Biothreat Panel is used to directly test a patient's blood to detect six pathogens listen by the U.S. CDC as biothreat agents. These pathogens include the bacterium that cause the diseases anthrax, glanders and meliodosis.
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T2 Biosystems applies for FDA Breakthrough Device designation for its T2Biothreat Panel