LEXINGTON, Mass., June 23, 2015 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (Nasdaq:TTOO), a company developing innovative diagnostic products to improve patient health, today announced the 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. In both studies, T2MR demonstrated strong correlation to a current standard of care, while doing so on a single instrument suitable for point of care testing, drug development, animal studies, and biomarker discovery. The results were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress in Toronto, Canada.
"The current gold standard test for measuring platelet function requires specialized equipment and personnel, 20-30 mLs of blood, takes several hours to provide results, and is most often a send-out test to a reference lab," said study investigator, Douglas B. Cines, M.D., Professor of Pathology and Laboratory Medicine, Medical Director of the Special Coagulation Laboratory, Perelman School of Medicine at the University School of Medicine at the University of Pennsylvania. "T2MR provides an opportunity to overcome these barriers to care using a more rapid and simple-to-use approach."
About the Studies
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T2MR Platelet Analysis Correlates with Light Transmission Aggregometry (LTA) and Rapidly Reveals Unique Details of ADP-Mediated Platelet Activation in Whole Blood: The current standard of care for measuring platelet activation, an important factor in making therapeutic, surgical, and transfusion decisions, generally requires specialized laboratories and personnel, large volumes of blood and takes approximately three hours to obtain a result. 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 (.04 ml of whole blood) while demonstrating 100 percent correlation to the current standard of care.
- 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 four key measures of coagulation: clotting time, platelet function, fibrinogen and fibrinolysis. These measures together are critical for determining patient risk for clotting or bleeding. In this study, T2MR was shown to rapidly (clot time and fibrinogen data detected within three minutes and platelet function within 20 minutes) and accurately assess (100 percent correlation to the standard of care) potential bleeding disorders through a single multiplex analysis of global hemostasis utilizing low blood volumes (.035 ml of 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 of 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 percent 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 has not been cleared by the U.S. Food and Drug Administration for use in hemostasis.
About T2MR
T2 Magnetic Resonance (T2MR) is a diagnostic detection method utilizing miniaturized magnetic resonance technology that measures how water molecules react in the presence of magnetic fields. T2MR is highly sensitive to changes in the microenvironment of a blood sample, such as clot formation, contraction and lysis. This enables the rapid identification of clinically relevant hemostasis changes.
About T2 Biosystems
T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary 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 the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. For more information, please visit www.t2biosystems.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the performance of the Company's diagnostic products and the ability to bring such products to market. These and other important factors discussed under the caption "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 4, 2015, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.