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.
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
- High risk patients or patients selected to use last line antibiotics
- Patients who are part of a stewardship program
- Patients with history of antibiotic use
- Patients not responsive to current therapy
- Patients who are immunocompromised
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.
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1. De Angelis G, editor. Clinical experience with a bacteria panel and resistance markers direct from whole blood. ECCMID; 2019.