T2 Biosystems, Inc. products

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.

The T2Candida® Panel is the first and only FDA-cleared direct-from-blood fungal pathogen detection assay, providing same-day results directly from a whole blood specimen for the most clinically relevant fungi.

The T2SARS-CoV-2 Panel, run on the T2Dx® Instrument, is a qualitative reverse transcriptase-polymerase chain reaction (RT-PCR) and T2 Magnetic Resonance (T2MR®) test. This test is designed for the direct detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens in transport media from individuals with signs and symptoms of COVID-19. The Panel is commercially available and was awarded Emergency Use Authorization (EUA) by the FDA on August 31, 2020. The T2SARS-CoV-2 Panel was validated in accordance with the EUA requirements from the FDA and is being distributed in accordance with the FDA guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).

The first direct-from-blood detection of resistance markers: The T2Resistance® Panel is designed for the direct-from-blood detection of antibiotic resistance genes associated with sepsis-causing pathogens. The Panel detects many of the resistance mechanisms described in the 2013 CDC Urgent Threat list. In 2019, the FDA granted “Breakthrough Device” designation for the T2Resistance Panel, reflecting the purpose of the panel to rapidly identify resistant infections. The T2Resistance Panel has not yet been submitted to the FDA for premarket review and is not available for clinical use in the United States.

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.

T2MR® technology powers all of the diagnostic innovations at T2 Biosystems. T2MR is a diagnostic detection method utilizing miniaturized magnetic resonance technology which measures how water molecules react in the presence of magnetic fields. Over 200 studies published in peer-reviewed journals have featured T2MR in a breadth of applications, including direct detection and measurement in targets such as whole blood, plasma, serum, saliva, sputum, and urine.

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 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).