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T2 Biosystems Files for FDA Clearance for Dx System, Candida Assay

NEW YORK (GenomeWeb) – T2 Biosystems today said that it has filed a 510(k) premarket submission with the US Food and Drug Administration for its T2Dx system and T2Candida assay.

The Lexington, Mass.-based firm said that it has submitted clinical trial data to the agency providing evidence that the instrument and assay can identify specific life-threatening, sepsis-causing pathogens directly from an unpurified blood sample in as fast as three hours. Current culture-based diagnostic methods typically take two to five days to provide an answer, T2 noted.

"This brings us one step closer to achieving our goal of helping physicians to more quickly and accurately diagnose certain sepsis-causing pathogens so they may make treatment decisions and administer targeted therapy to patients on an accelerated basis," John McDonough, President and CEO of T2 Biosystems, said in a statement. "We believe that the diagnostic capabilities offered by T2Dx and T2Candida have the potential to contribute to T2 Biosystems' overarching goal of saving lives, improving patient outcomes, and reducing healthcare costs."

T2 Bio was founded in 2006 and its technology, which comes out of research performed at the Massachusetts Institute of Technology, uses superparamagnetic nanoparticles made up of a superparamagnetic metal core, polymer layer, and analyte-specific binding agents. The firm said its technology can detect cellular targets at limits of detection as low as one colony –forming unit per milliliter.

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