T2 Biosystems
101 Hartwell Avenue
Lexington, MA 02421
Phone: 781-457-1200
Fax: 781-357-3080
The FDA-cleared T2Biothreat® Panel is a direct-from-blood molecular diagnostic test that runs on the FDA-cleared T2Dx® Instrument and simultaneously detects six biothreat pathogens identified as threats by the U.S. Government, including the organisms that cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis), and typhus (Rickettsia prowazekii).
The T2Biothreat Panel is the first and only FDA-cleared product able to detect these six high-priority biothreat pathogens simultaneously, and the only multi-target biothreat product developed and manufactured by a U.S.-owned company. The U.S. clinical evaluation to support the FDA 510(k) submission included testing of the T2Biothreat Panel at MRIGlobal, a Biosafety Level 3 laboratory specializing in biothreat pathogens, and Oschner Medical Center.
T2MR® Technology: The T2Biothreat Panel utilizes the same T2MR® Technology and T2Dx Instrument as the T2Bacteria® and T2Candida® Panels – the first and only FDA-cleared and CE-marked panels for detection of sepsis-causing bloodstream infections direct from a patient’s blood sample, without requiring blood culture results.
Administration for Strategic Preparedness & Response (ASPR) PHEMCE High Priority Biological Threats List.
T2 Biosystems, an emerging leader in the field of in vitro diagnostics, is dedicated to saving lives and reducing the cost of healthcare by empowering clinicians to effectively treat patients faster than ever before. T2 Biosystems is focused on addressing critical unmet needs in healthcare starting with sepsis, one of the deadliest and most expensive conditions in hospitals today.
The T2Dx Instrument, the T2Bacteria and T2Candida Panels have received marketing authorization from the U.S. Food and Drug Administration. All other T2 Biosystems products are considered investigational and for research use only.
T2 Biosystems®, T2MR®, T2Bacteria®, T2Candida®, T2Resistance® and T2Dx® are registered trademarks of T2 Biosystems, Inc. “T2Biosystems” and the T2 Biosystems, Inc. logo design are registered trademarks or trademarks of T2Biosystems, Inc. All software and documentation is subject to T2 Biosystems, Inc. copyrights. All rights reserved. T2Direct Diagnostics™, T2HemoStat™, T2Plex™, T2Cauris™, T2Lyme™ and T2SARS-CoV-2™ are trademarks of T2 Biosystems, Inc.
© 2024 T2 Biosystems, Inc.
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