T2 commences with Candida assay pivotal trial

T2 Biosystems is diving into a pivotal trial for its flagship T2Candida rapid diagnostic assay, a massive effort that will involve as many as 1,500 patients at 7 different hospitals. Dubbed direcT2, the effort is expected to run through early 2014, after which the 2012 Fierce 15 company will file a petition during the 2014 first quarter for a de novo/510(k) designation from the FDA. The test relies on magnetic resonance technology to help detect the possible presence of Candida in blood or urine within a few hours, and is based on technology developed by Massachusetts General Hospital, Harvard University and MIT's Robert Langer. Story

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