T2 Biosystems, Inc. products

The T2Cauris™ Panel RUO provides direct detection of the emerging superbug Candida auris in patient skin and patient blood and is now available for research use. The Centers for Disease Control and Prevention (CDC) validated the T2Cauris™ Panel RUO swab test on patient skin samples and published their findings in Mycoses.1

Detection of biothreat pathogens in 3-5 hours— direct from whole blood: The T2Biothreat® Panel, which runs on the T2Dx® Instrument, is a direct-from-blood test panel that provides results in 3-5 hours and simultaneously detects six biothreat pathogens identified as threats by the U.S. Government, including B. anthracis, F. tularensis, B. mallei , B. pseudomallei, Y. pestis, and R. prowazekii. Clinical Trial: The T2Biothreat clinical trial for evaluating the Panel was initiated in December 2021, and will support a submission to the U.S. Food and Drug Administration (FDA).

The T2Lyme™ Panel is designed to provide greater accuracy in the diagnosis of early Lyme disease, which may help improve care and lead to better patient outcomes, The T2Lyme™ Panel identifies the bacteria that cause Lyme disease directly from a patient’s blood. T2Lyme runs on the FDA-cleared T2Dx® Instrument, the same instrument currently used to run the FDA-cleared and CE marked T2Bacteria® and T2Candida® Panels. Undetected, underdiagnosed, and undertreated: Lyme disease is a tick-borne bacterial infection that, if left untreated, can cause chronic joint inflammation, neurological disorders, and cognitive defects. According to the Centers for Disease Control and Prevention (CDC), approximately 30,000 cases of Lyme disease are reported in the United States each year. However, due to poor diagnostic testing, the CDC estimates the actual number is closer to 360,000.1

The FDA-cleared and CE-marked T2Dx® Instrument is a fully automated, walk away, clinical multiplex benchtop diagnostic system capable of running tests directly from whole blood.

The T2Bacteria® Panel is the first and only FDA-cleared test to identify sepsis-causing bacteria directly from whole blood without the wait for blood culture.