The Lexington, Mass.-based company, in partnership with Canon USA, said it expects to wrap up preclinical studies for its T2Lyme Panel this year, followed by a clinical trial for FDA submission in 2018.
“This study shows strong evidence that Lyme disease-causing bacteria exist transiently in blood,” co-author Dr. Thomas Fritsche said in prepared remarks. “T2MR is the only technology proven sensitive enough to directly detect these bacteria.”
Traditionally, researchers use serology to diagnose Lyme disease by detecting antibodies that are triggered by the disease. There is no FDA-approved diagnostic based on direct measurement of Lyme disease-causing bacteria.
Regulatory agencies recommend a 2-tiered approach to diagnose Lyme disease, but the technique detects 2 antibodies that require 1-2 weeks and 4-6 weeks to reach detectable levels, leaving a window where diagnosis of early Lyme disease is not possible.
T2MR detected both confirmed cases of Lyme disease tested in the study, as well as 17 samples from patients thought to have Lyme disease. The company’s diagnostic system outperformed conventional PCR methods, which only detected 1 case of of Lyme disease-causing bacteria.
Researchers also noted that T2’s system was much more analytically sensitive than conventional techniques.
“T2MR is a method to detect Lyme spirochetes in whole blood that promises rapid and reliable sample-to-answer results and this study offers insight to how this diagnostic may improve clinical care for individuals with Lyme disease,” co-author Steven Callister added.
The post T2 Biosystems’ T2MR detects Lyme disease-causing bacteria in blood appeared first on MassDevice.
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