T2 Biosystems Submits 510(k) Application to the FDA for Review of T2Dx and T2Candida

T2 Biosystems Submits 510(k) Application to the FDA for Review of T2Dx and T2Candida

June 3, 2014

LEXINGTON, Mass.--()--T2 Biosystems today announced that it has filed a 510(k) premarket submission for T2Dx and T2Candida with the U.S. 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.

“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,” said John McDonough, President and CEO, T2 Biosystems. “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.”

Sepsis is one of the leading causes of death in the United States and the most expensive hospital-treated condition, with costs to the healthcare system exceeding $20 billion each year. Studies have shown that if Candida, the most lethal form of common blood stream infections that cause sepsis, can be diagnosed and treated with targeted therapy beginning within 12 hours of presentation of symptoms, the associated mortality rate can be reduced from 40 to 11 percent.

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.

About T2 Biosystems

T2 Biosystems is an in vitro diagnostics company that is using its T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets at limits of detection as low as one colony-forming unit per milliliter, or CFU/mL. T2 Bio's initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics.

The T2Candida test and the T2Dx instrument are for Investigational Use Only. The performance characteristics of these products have not yet been established.

T2 Biosystems®, T2MR®, T2Candida®, T2Dx® are registered trademarks of T2 Biosystems, Inc.