TTOO - T2 Biosystems seeks FDA breakthrough designation for C. auris test
2023-06-05 14:18:13 ET
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 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.
More on T2 Biosystems:
T2 Biosystems up 31%, gets second largest order for sepsis-driven instrument
T2 Biosystems affirms plans to add Candida Auris fungus detection to test panel
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T2 Biosystems seeks FDA breakthrough designation for C. auris test