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Medical device maker T2 Biosystems (NASDAQ:TTOO) has submitted an application to the US Food and Drug Administration for breakthrough device designation for its detection test for the emerging pathogen Candida auris.
T2 plans to add C. auris detection to its FDA-cleared T2Candida Panel. The pathogen, which is a multi-drug resistant fungus, has been declared a serious public health threat by the US Centers for Disease Control and the World Health Organization and carries a mortality rate of up to 60%, according to T2.
The T2Candida Panel is used to rapidly detect sepsis-causing pathogens directly from whole blood.
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T2 Biosystems affirms plans to add Candida Auris fungus detection to test panel