T2Bacteria Panel

The fastest species identification of major bacteria directly from whole blood without the wait for blood culture

The T2Bacteria® Panel is the first and only FDA-cleared, direct from blood bacteria pathogen identification test that does not require blood culture. It is now available commercially in the United States and identifies many of the most deadly and prevalent bacteria species. By screening suspected patients at the first sign of infection, physicians can start targeted therapy far faster, potentially preventing the onset of sepsis and increasing the odds of both survival and a rapid recovery.

At the April 2018 European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), pivotal T2Bacteria Panel clinical trial data was presented by Minh-Hong Nguyen, M.D. of UPMC. Dr. Nguyen highlighted the excellent performance of the T2Bacteria Panel and noted several shortcomings of blood culture:

  • Blood culture was found to be limited as a gold standard for detecting bloodstream infection, with “suboptimal sensitivity” and “slow turnaround time."
  • Blood culture ID results took an average of 3 days while T2Bacteria took only hours in the clinical trial.
  • T2Bacteria detected infected patients on antibiotics who were missed by blood culture.
  • T2Bacteria results may expedite life-saving interventions such as the targeting of therapy within hours of blood draw.

Clinicians have presented data and case studies on the T2Bacteria Panel RUO at conferences throughout the year, highlighted by a retrospective study of patient samples at Northwestern University (video, white paper) during the Association for Molecular Pathology (AMP) 2017 Conference. The analysis concluded that the T2Bacteria Panel RUO detected true, confirmed bacterial infections at a higher rate than blood culture.

Potential Impact of the T2Bacteria Panel in the Emergency Room

As the first responders for acute disease, emergency department physicians are on the frontline for managing patients suspected of sepsis. Rapid results could significantly accelerate disposition, especially when placing patients in observation.

In a presentation delivered at IDWeek 2017, Glen T. Hansen, PhD, Director of Clinical Microbiology and Molecular Diagnostics, Hennepin County Medical Center, found that the investigational data on T2Bacteria highlighted the panel’s potential clinical value for the emergency department and inpatient care.

At ASM Microbe 2017, Mitchell Cohen, MD, a professor at the University of Colorado School of Medicine, reported that T2Bacteria can be easily integrated in the emergency department setting due to its rapid turnaround time, while blood culture-reliant tests cannot.

“Bacterial infections are a major cause of poor health outcomes and a driver of costs in hospitals today. There is a great need for improved diagnostics to aid clinicians in providing faster treatment, and the T2Bacteria Panel is the first product submitted for FDA clearance that detects bacteria species directly from whole blood, providing faster, actionable information.”

Mitchell J. Cohen, MD,  a professor at the University of Colorado School of Medicine.

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1. T2Bacteria Pivotal Clinical Study. This is a combination of samples run in both prospective and contrived arm of study. T2Bacteria showed an overall average sensitivity of 90% in the prospective arm of the study and the contrived arm an overall average PPA of 97%.