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.
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.
"The direcT2 trial initiation is a significant milestone for T2 Bio in our mission to improve patients’ lives utilizing T2MR, our disruptive diagnostic technology," he said in prepared remarks. "T2Candida is the first of many applications to emerge from our T2MR technology, which can directly detect molecular, immunoassay or hemostasis targets from complex clinical samples, such as whole blood, and we look forward to the results of the trial, which we expect to report in the 1st half of 2014."