July 22, 2013 — T2 Biosystems announced the presentation of data strongly correlating T2Hemostat results with patients’ clinical outcomes. In 26 patients who presented with chest pain and underwent cardiac catheterization, T2HemoStat was compared to a common platelet activity assay, where T2HemoStat accurately correlated to 100 percent of bleeding event cases while the comparator did not identify bleeding events in any patients. T2HemoStat also correlated to twice the number of thrombotic cases than the comparator. These data are complemented by additional presentations that demonstrate T2MR’s ability to identify novel clot biology, which may account for previously unexplained clot behavior while providing new clinical insights into the formation and degradation of blood clots. T2HemoStat is the company’s novel system for the rapid detection of physical changes in a blood sample, identifying novel clot biology while also measuring hemostasis characteristics such as coagulation, fibrinolysis and platelet function from finger stick size, small volumes of whole blood or plasma on a single, compact instrument.
These T2HemoStat studies were presented at the XXIV Congress of the International Society on Thrombosis and Haemostasis (ISTH), June 29-July 4, 2013, in Amsterdam, the Netherlands. The research was presented by collaborators at the University of Pennsylvania and Saint Vincent Hospital of Worcester, Mass., and by Thomas Lowery, vice president of Diagnostics R&D of T2 Bio.
“There have been many challenges to developing a clinically valuable, timely and simple method to monitor platelet function in patients who have received interventional therapies,” commented Yuka-Marie Vinagre, M.D., Ph.D., chief, Critical Care Medicine, Saint Vincent Hospital and lead author of the outcomes study utilizing T2HemoStat. “In our study presented at ISTH, we were able to demonstrate that T2HemoStat is a potential method to predict the outcomes of these interventional cardiac patients. It is very simple to use and appears to have excellent clinical correlation.”
Additional studies presented at the ISTH 2013 Congress demonstrate the capabilities of T2 Bio’s core technology, T2MR, to rapidly perform multiple hemostasis measurements on a single system, including the identification of novel clotting processes that create previously unobserved clot biology.
“These new data describe a rapid and reliable means to assess a range of hemostatic conditions directly from whole blood using a single instrument, which should enhance the ability of physicians to help make important treatment decisions in a more timely manner,” said Douglas B. Cines, M.D., professor of pathology and laboratory medicine and director of the Special Coagulation Laboratory, Perelman School of Medicine-University of Pennsylvania. “In addition, by observing clotting behavior in its more natural environment of whole blood, T2HemoStat is able to provide clinicians and researchers with valuable insight into novel aspects of clotting biology.”
“T2 Bio is committed to demonstrating the value of our T2MR technology as a means to directly detect virtually any molecular, immunodiagnostic or hemostasis target,” added John McDonough, president and CEO, T2 Biosystems. “We are extremely grateful for the work our collaborators at the University of Pennsylvania and Saint Vincent Hospital have done to advance this understanding through the studies on hemostasis measurements presented at ISTH. These new data highlight the potential clinical relevance of the T2HemoStat test, as well as the research possibilities enabled by the elucidation of novel platelet biology.”
Presentations at ISTH
1. A clinical pilot study to compare T2MR and VerifyNow P2Y12 platelet activity measurements in cardiovascular patients by Y.M. Vinagre, R. Niroula, L. Chhabra, W. Massefski and T.J. Lowery
Poster Presentation: July 1, 2013; 17:00-18:30; Abstract: 3334
2. Contraction of whole blood clots: platelets and fibrin on the exterior compress erythrocytes into close-packed polyhedral on the interior by D.B. Cines, T. Lebedeva, C. Nagaswami, V. Hayes, W. Massefski, L. Rauova, T.J. Lowery and J.W. Wiesel
Poster Presentation: July 3, 2013; 17:00-18:30; Abstract: 3364
3. Real-time dynamic measurement of hemostasis and fibrinolysis and detection of hemostatic and prothrombotic blood disorders by T2 magnetic resonanceby D.B. Cines, T. Lebedeva, M.A. Kowalska, M. Poncz, L. Rauova, A. Cuker, J.W. Weisel, J. Whitten, L.R. Skewis, W. Massefski, V. Papkov, E.C. Thayer and T.J Lowery
Oral Presentation: July 4, 2013; 16:45-17:00; Abstract: 3055
For more information: www.t2biosystems.com