FDA greenlights test to detect sepsis-causing bacteria in blood

The FDA granted market clearance to T2 Biosystems' test to detect sepsis-causing bacterial pathogens in blood samples, the company announced May 29.

The T2Bacteria Panel can identify the following types of sepsis-causing bacteria species:

  • Enterococcus faecium
  • Escherichia coli
  • Klebsiella pneumoniae
  • Pseudomonas aeruginosa
  • Staphylococcus aureus

Most diagnostic tests for bacteria in the blood require a positive blood culture sample before a bacteria species can be identified, which can postpone results by one to five days. However, the T2Bacteria Panel can achieve results in about five hours.

"The FDA's market clearance of the T2Bacteria Panel is a significant milestone for our company, but more importantly, for millions of patients at risk of sepsis from bloodstream infections," said John McDonough, president and CEO of T2 Biosystems. "This breakthrough technology provides potentially life-saving answers for patients and economic savings to hospitals that bear the enormous burden of sepsis-related care and mortality."

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