FDA Clears T2 Bio Test, System for Identification of Yeast Pathogens | GenomeWeb

NEW YORK (GenomeWeb) – The US Food and Drug Administration has cleared a molecular diagnostic test and instrument from T2 Biosystems for the detection of five yeast pathogens that cause bloodstream infections.

The T2Candida panel and the T2Dx Instrument are for the direct detection of Candida species in human whole blood specimens from patients with symptoms of invasive fungal infections or with conditions that predispose them to such infections.

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