Study Results on T2Bacteria Panel for Sepsis from Whole Blood
T2 Biosystems, Inc. have announced that data on its investigational T2Bacteria Panel will be presented at the Association of Molecular Pathology (AMP) 2015 Annual Meeting in Austin, Texas. The data demonstrate the ability of T2Bacteria to provide the rapid and sensitive identification of six sepsis-causing bacteria, directly from whole blood, with limits of detection as low as 1 CFU/mL. The six clinically relevant bacteria included in the T2Bacteria Panel are: Staphylococcus aureus, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii.
"This is the first time study results demonstrate a rapid and sensitive bacterial species diagnosis direct from whole blood and without the need for blood culture," said Mike Pfaller, M.D., chief medical officer of T2 Biosystems. "The implications of these data are significant, enabling physicians to implement more timely targeted antibiotic therapy, potentially saving patient lives."
"The use of T2Candida and T2Bacteria, when combined with the practice of empirically administering broad spectrum antibiotics, may typically enable 95% of patients with sepsis to receive rapid and appropriate therapy," said John McDonough, chief executive officer of T2 Biosystems. "We are excited that the data in this study demonstrate the potential of T2Bacteria to enable the reduction in the current mortality rate of bacterial sepsis by 50%."
About the Study:
The T2Bacteria Panel is being designed to run on the T2Dx instrument in conjunction with the T2Candida Panel. To achieve similar clinical performance to the T2Candida Panel, published data show that the T2Bacteria Panel will need to achieve a limit of detection (LoD) below 10 CFU/mL for each species. T2MR was able to demonstrate a high analytical sensitivity and high specificity for all bacterial targets. A LoD as low as 1 CFU/mL was observed for the targeted bacteria species spiked into healthy blood. The LoD for all bacterial species tested was determined by the cell concentration (CFU/mL) that resulted in a 95% or greater detection rate for 20 samples.
Data demonstrate the T2Bacteria Panel's ability to achieve limits of detection below 10 CFU/mL, and as low as 1 CFU/ml, similar to the performance demonstrated for the T2Candida Panel, in six clinically relevant bacteria species.
The six bacteria in the T2Bacteria Panel were selected because when combined with the use of T2Candida and the practice of empirically administering broad spectrum antibiotics, the rapid detection of these bacteria may enable 95% of patients with sepsis to receive rapid and appropriate therapy. These bacteria comprise 55% of all positive blood cultures and have growing resistance profiles.
Tags: Staphylococcus aureus, Sepsis, Acinetobacter, Enterococcus, Klebsiella, Pseudomonas aeruginosa
Date Published: November 10, 2015
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