Clinical Chemistry Study Reports on Use of T2MR to Evaluate Hemostasis in Whole Blood

Clinical Chemistry Study Reports on Use of T2MR to Evaluate Hemostasis in Whole Blood

June 23, 2014

-Results Suggest T2MR Has Potential to Provide Rapid and Sensitive Identification of Patients at Risk for Thrombosis and Bleeding-

LEXINGTON, Mass. – T2 Biosystems today announced that scientists from the University of Pennsylvania and T2 Biosystems have published a manuscript in Clinical Chemistry evaluating the use of T2MR technology for studying comprehensive hemostasis in whole blood. Titled “T2 magnetic resonance: a diagnostic platform for studying integrated hemostasis in whole blood – proof of concept,” the publication explores the potential of 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.

“Existing approaches for measuring a panel of hemostasis parameters including platelet activity typically require multiple and often relatively complex platforms, large volumes of blood and can take several hours to provide results. These limitations can make it difficult to obtain many of the rapid and accurate assessments of hemostasis that are often needed to effectively guide therapeutic decisions,” said study lead author Douglas B. Cines, MD, Professor of Pathology and Laboratory Medicine and Director of the Special Coagulation Laboratory, Perelman School of Medicine at the University of Pennsylvania. “These new results suggest that T2MR has the potential to address this need by providing more rapid and sensitive identification of patients at risk for thrombosis or bleeding using a single, simple-to-use approach.”

The T2MR diagnostic technology platform is a research and investigational product that has potential to provide a comprehensive assessment of hemostatic parameters on a single instrument in less than 20 minutes using very small volumes of blood (0.04 ml). The technology works by measuring how water molecules react in the presence of magnetic fields and is highly sensitive to changes in a blood sample (such as clot formation, stabilization or dissipation), which alter the magnetic resonance signal and enable identification of clinically relevant hemostasis changes.

About the Study

In the research study, T2MR signals of clotting samples were compared with standard reference methods for hematocrit, prothrombin time, clot strength and platelet activity. Results suggest that the T2MR platform may be used for more precise and accurate measurements of hematocrit, clotting time, clot strength and platelet function. This paper builds on research published in December 2013 in the hematology journal Blood, in which T2 Biosystems and University of Pennsylvania researchers announced the discovery of a novel blood clot structure. The Clinical Chemistry study compares T2MR signals of clotting samples with images produced by scanning electron microscopy to demonstrate how researchers were able to apply T2MR methodology to reveal the conditions under which this unique blood clot appeared. Further investigations will determine the clinical potential of using this T2MR signature to identify patients at risk of thrombosis or bleeding or stroke and heart attack victims where such clots may be less responsive to medications.

“These data provide further evidence that support T2MR’s ability to provide critical hemostasis measures both clinically and in the identification of new biomarkers and therapeutic targets,” said Tom Lowery, Ph.D., Chief Scientific Officer of T2 Biosystems and co-author of the study.

One future application of T2MR’s more rapid potential assessment capabilities is in trauma settings involving impaired hemostasis, a potentially life-threatening condition in which a patient is unable to form blood clots to stabilize excessive bleeding. Research has shown that mortality of trauma patients with symptoms of impaired hemostasis can be reduced from 45 to 19 percent with more rapid detection and delivery of therapy. Approximately 25 percent of trauma patients have impaired hemostasis that currently often goes undetected.

T2MR is currently intended for research use only. It is not intended for use in diagnostic procedures.

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.

 

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