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 2019 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.
Early Data: The T2Resistance Panel can detect 13 resistance genes from both gram-positive and gram-negative pathogens direct from blood. There is broad inclusivity of resistance variants and ≤10 CFU/mL detection demonstrated for all targets. Developmental studies have shown no cross-reactivity or inhibition by common interfering substances. Studies have also shown a dramatic decrease in time to resistance gene identification.1
Accelerated identification to combat antibiotic resistance: Direct-from-blood rapid diagnostics have the potential to prevent the spread of multi-drug-resistant organisms and improve patient outcomes by enabling rapid identification of the genes and species associated with antibiotic resistance – enabling appropriate therapy and the reduction of unnecessary antibiotic use, which is the cause of resistance in the first place. Most importantly, these tests can enable more patients to get on the right targeted therapy faster, potentially reducing mortality and hospitalization cost.
T2Resistance Panel RUO
The T2Resistance Panel RUO is currently available as a research use only (RUO) Panel. The product is available for research studies.
Potential study populations
T2MR® Technology: The T2Resistance Panel RUO utilizes the same 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.
Contact us to learn more about the T2Resistance Panel RUO!
1. De Angelis G, editor. Clinical experience with a bacteria panel and resistance markers direct from whole blood. ECCMID; 2019.
Gram-negative marker
KPC
OXA-48 Group
NDM /VIM/IMP
CTX-M 14/15 AmpC(CMY/DHA)
Gram-positive marker
vanA/B
mecA/C
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.
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