T2 Biosystems plans to seek FDA OK for diagnostic device
T2 Biosystems Inc. today released data showing that its NanoDx diagnostic device speeds the detection of the fungal infection Candida, often identified as a hospital-acquired bloodstream infection, from five days to only hours.
The Lexington company said that the diagnostic, based on its Magnetic Biosensor Technology, can identify five strains of Candida species from whole blood samples in less than two hours. In a press release, the company said the system utilizes magnetic biosensor nanotechnology that is designed to enable detection of DNA, RNA, protein, small molecules and a number of other targets. T2 plans to submit the diagnostic device, including the Candida application, for clearance by the U.S. Food and Drug Administration in 2012.