Magnetic Resonance Improves Approach to Measuring Hemostasis Parameters

At the International Society on Thrombosis and Hemostasis (ISTH) 2015 Congress (Toronto, Canada), T2 Biosystems, Inc. (Lexington, MA, USA) presented results of two investigational studies highlighting the capability of its T2 Magnetic Resonance (T2MR) detector to accurately and rapidly measure hemostasis parameters directly in whole blood. T2MR, a single easy-to-use instrument, demonstrated strong correlation to a current standard-of-care. It is suitable for applications such as point-of-care testing, drug development, animal studies, and biomarker discovery.

One study was “T2MR Platelet Analysis Correlates with Light Transmission Aggregometry (LTA) and Rapidly Reveals Unique Details of ADP-Mediated Platelet Activation in Whole Blood.” In this study, T2MR detected the most clinically valuable platelet parameters to provide an assessment of platelet activity in just 20 minutes using low blood volumes (0.04 mL of whole blood) while demonstrating 100% correlation to the current standard-of-care. "The current gold standard test for measuring platelet function requires specialized equipment and personnel, 20–30 mL of blood, takes several hours to provide results, and is most often a send-out test to a reference lab," said Douglas B. Cines, MD, professor of Pathology and Laboratory Medicine at the University of Pennsylvania’s medical school, "T2MR provides an opportunity to overcome these barriers to care using a more rapid and simple-to-use approach."

The second study was “Whole Blood Platelet Activity Measurements Multiplexed with Quantitative Fibrinogen, Clot Time and Fibrinolysis Measurements by T2MR.” Currently, there is no single solution for rapidly measuring the 4 critical measures of coagulation: clotting time, platelet function, fibrinogen, and fibrinolysis. In this study, T2MR was shown to rapidly (clot time and fibrinogen data detected within 3 minutes; platelet function within 20 minutes) and accurately assess (100% correlation to the standard-of-care) potential bleeding disorders through a single multiplex analysis of global hemostasis utilizing low blood volumes (0.035 mL whole blood). In addition, T2MR generated robust signatures that have led to the discovery of novel biomarkers that may potentially have other important clinical applications.

"We are very encouraged by these data and for T2MR to make a potentially critical difference in providing physicians with the accurate, timely hemostasis information needed to make important treatment decisions for patients," said John McDonough, CEO, T2 Biosystems, "In trauma, for example, research has shown that mortality in patients with symptoms of impaired hemostasis can be reduced from 45% to 19% with more rapid detection and delivery of treatment. We believe that T2MR has the potential to address a significant unmet need that can bring significant benefits to the health of patients and the cost of healthcare."

T2MR is a diagnostic detection method utilizing miniaturized magnetic resonance technology that measures how water molecules react in the presence of magnetic fields. It is highly sensitive to changes in the microenvironment of a blood sample, such as clot formation, contraction, and lysis. This enables rapid identification of clinically relevant hemostasis changes.

T2MR has currently not been cleared by the US Food and Drug Administration (FDA) for use in hemostasis.

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T2 Biosystems, Inc.