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

Suggested Articles

BD will begin working with Babson Diagnostics to help bring its lab-quality device for collecting blood from capillaries into retail pharmacies.

The former CEO of the molecular testing company Foundation Medicine, Troy Cox, has been named chairman of the Swiss big data firm Sophia Genetics.

Researchers at MIT used a machine-learning algorithm to uncover the potent antibiotic properties hiding within an old small-molecule candidate.