T2 Biosystems has filed a 510(k) premarket submission for T2Dx and T2Candida with the US Food and Drug Administration (FDA).
The premarket submission includes clinical trial and other data providing evidence that the T2Dx instrument and the T2Candida test panel may identify specific life-threatening sepsis-causing pathogens directly from an unpurified blood sample as fast as three hours, rather than the two to five days typically required for blood culture-based diagnostics.
T2 Biosystems president and CEO John McDonough said that this brings us one step closer to achieving the company’s 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.
"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," McDonough added.
T2Dx and T2Candida are powered by T2MR, an innovative and proprietary magnetic resonance-based diagnostic technology platform that may offer a rapid, sensitive and simple alternative to the current clinical standard in diagnostics.