T2 Biosystems Files for FDA Clearance for Dx System, Candida Assay | GenomeWeb

NEW YORK (GenomeWeb) – T2 Biosystems today said that it has filed a 510(k) premarket submission with the US Food and Drug Administration for its T2Dx system and T2Candida assay.

The Lexington, Mass.-based firm said that it has submitted clinical trial data to the agency providing evidence that the instrument and assay can identify specific life-threatening, sepsis-causing pathogens directly from an unpurified blood sample in as fast as three hours. Current culture-based diagnostic methods typically take two to five days to provide an answer, T2 noted.

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