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T2 Biosystems Up After Submission for FDA Breakthrough Device Designation

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By Michel Dabaie

Shares of T2 Biosystems Inc. rose in premarket trading on Wednesday after the company said it submitted an application to the U.S. Food and Drug Administration for breakthrough device designation for its T2Biothreat Panel.

The T2Biothreat panel is a direct blood test panel intended to be run on the company’s T2Dx instrument. The company said the panel is designed to simultaneously detect six biothreat pathogens that are listed by the U.S. Centers for Disease Control and Prevention as Category A and B biothreat agents. The CDC has determined that these organizations pose a national security risk.

Shares of the company, which focuses on the rapid detection of pathogens that cause sepsis and antibiotic resistance genes, rose 13%, to 45 cents, in premarket trading.

Write to Michael Dabaie at [email protected]

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