T2 Biosystems launches sepsis trial

September 11, 2013 by Brad Perriello

T2 Biosystems launches a clinical trial of its T2Candida test to detect Candida, a leading cause of hospital-acquired infections that can lead to deadly cases of sepsis.

T2 Biosystems launches sepsis trial

T2 Biosystems said it's launched a clinical trial of its MR-based test for a fungus that's a common cause of deadly hospital-acquired infections.

The Lexington, Mass.-based company said it plans to use the study results to back a regulatory submission for the T2Candida test for the Candida fungus, estimated to cause some 100,000 cases of candidemia each year in the U.S.

Candidemia's 40% mortality rate can be slashed to 11% with early detection, according to T2 Biosystems. The T2Candida test can detect a single colony-forming unit in a 1 milliliter sample in about 3 hours, the company says, compared with the 100- to 1,000-CFU limitation imposed by molecular diagnostic technology which takes 3 days to culture.

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T2 Biosystems drummed up a $40 million Series E round earlier this year that CEO John McDonough told MassDevice.com would go toward the clinical trial and the eventual commercialization of the T2Candida test. The trial will likely run for about 6 months, McDonough told us, with FDA clearance expected sometime in 2014.