T2 Biosystems

Our T2Bacteria® and T2Candida® Panels run on the automated T2Dx® Instrument. They are the first and only FDA-cleared blood tests that identify sepsis-causing pathogens without the wait for blood culture.

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T2Dx Instrument

Breakthrough technology enabling direct detection from whole blood

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

The benefits of the T2Dx Instrument include

- Rapid results
 -  Easy to operate
 - Performs with 4 mL whole blood (No blood culture)
 - Random access
 - Simple user interface
 - One instruments, multiple tests

“(5). Peker, N., et al. Table 1. Clin Microb &Inf, 2018.”

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T2Bacteria Panel

Enhance the standard of care for sepsis — by detecting bloodstream infections sooner

The T2Bacteria® Panel is the first and only FDA-cleared and CE-marked panel to detect five clinically relevant bacterial pathogens in 3 to 5 hours, directly from a whole blood sample. E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, and E. coli represent the majority of bacteremia seen in the emergency department and those causing hospital-acquired infections. In addition, several of these species are known as ESKAPE pathogens, characterized as virulent and difficult to treat with empiric antimicrobial therapy, making faster species identification and targeted treatment critical to improving patient outcomes.

The positive clinical impact of T2Bacteria

- Target therapy sooner by reducing the time to species ID
 - Increase clinician confidence in treatment with accurate and reliable results
 - Impact patient outcomes and reduce length of stay for patients with bloodstream infections
 - Improve antimicrobial stewardship

“(11). DeAngelis, Presentation ECCMID 2019.”

T2Candida Panel

Faster targeted therapy leads to reduced costs and improved outcomes

The T2Candida® Panel is the first and only FDA-cleared diagnostic test for the detection of sepsis-causing fungal pathogens, direct from whole blood. Species identification is provided within 3 to 5 hours of the first blood draw and independent of a positive blood culture, often before the second dose of antimicrobials is administered.

The positive clinical impact of T2Candida

- Better patient outcomes
 - Unprecedented speed and accuracy
 - Faster targeted therapy
 - Improved stewardship and pharmacy savings

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“(10). Snyder J, World Microbe Forum: Industry & Science Symposium.2021.”

1 What is the relationship between time to effective therapy and mortality from sepsis and bacteremia?
One of the best predictors of mortality due to bacteremia and sepsis is time to effective therapy. This has been demonstrated in multiple publications:

1. In 2,731 septic shock patients, during the first 6 hours of hospital care, every hour delaying effective antimicrobial therapy reduced survival by 7.6%.

2. In 111,816 patients given a New York state-mandated sepsis bundle, every hour delaying appropriate antibiotic therapy increased odds of death by 4.0% .

In a meta-analysis of 70 studies, compared to patients given an appropriate empiric antibiotic therapy, patients given inappropriate empiric antibiotics showed over two-times higher odds of death. These studies support that rapid and targeted therapy to treat bacteremia and sepsis saves lives.
2 What is a typical time to species ID from blood culture dependent methods, the T2Candida Panel, and the T2Bacteria Panel?
In a 2016 study of 165,593 blood cultures from 13 acute care hospitals in the United States, the median time to species identification was 44.0 hrs. By species, the medians ranged from 36.0 to 90.2 hrs. In the 2014 T2Candida Pivotal study, the mean time to species identification for blood culture dependent methods was 129.9 ± 26.3 hrs. In contrast, for the T2Candida Panel, the mean time to species identification was 4.4 ± 1.0 hrs. The mean difference in time to species identification between blood culture dependent methods and the T2Candida Panel was 125.5 hrs. or 5.2 days. In the 2017 T2Bacteria Pivotal study, the mean time to species identification for blood culture dependent methods was 71.7 ± 39.3 hrs. In contrast, for the T2Bacteria Panel, the mean time to species identification depended on the number of samples loaded and ranged from 3.61 ± 0.2 hrs. for 1 sample loaded to 7.70 ± 1.38 hrs. for a full load of 7 samples. Comparing against a full load of 7 samples, the mean difference in time to species identification between blood culture dependent methods and the T2Bacteria Panel was 64.0 hrs. or 2.7 days.
3 The T2Bacteria Panel detects five species: E. coli, E. faecium, K. pneumoniae, P. aeruginosa, and S. aureus. What proportion of all bacteremia species does the panel cover?
Depending on the patient population and hospital ward, the T2Bacteria Panel will cover 50 to 70% of all bacteremia. Notably, the panel covers 90% of bacteremia by ESKAPE pathogens, which are pathogens at particularly high risk of resisting broad spectrum antibiotics and could benefit from a species-directed change in therapy. So, the value of the T2Bacteria Panel is accelerating the time to species directed therapy adjustments for 50 to 70% of all bacteremia and 90% of ESKAPE bacteremia to just 3 to 5 hours.
4 How does the positivity of blood culture and T2 assays change with administration of antibiotics?
In a study of 559 septic ICU patients, prior administration of antibiotics resulted in 60% lower odds of a blood culture positive. Similarly, in a study of 25,686 emergency department patients, prior administration of antibiotics for as little as 2 hours reduced blood culture positivity by over 50%. Therefore, prior administration of antibiotics can be a major source of reduced positivity in blood culture methods. In contrast, since T2 assays do not require cell growth, the assays show no interference from antimicrobials even at supraphysiological levels.

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