New Data Suggests T2 Biosystems’ T2Lyme™ Panel is More Accurate than Other Diagnostics for Identifying Borrelia Infections for Patients Suspected of Having Early Lyme Disease
The data from a 2017 pre-clinical study evaluated 21 patients enrolled with an erythema migrans (EM) rash with suspected early Lyme disease and assessed with multiple Lyme diagnostics. The study compares various diagnostic methods with the
“We are excited that the pre-clinical data is promising as the
The data in the poster was co-authored by clinicians and experts from
About Lyme Disease & Current Diagnostics
Lyme disease is caused by Borrelia bacteria that is transmitted to humans through the bite of infected ticks. The symptoms patients commonly see are fever, headache, fatigue, and a skin rash called erythema migrans (EM). The infection can spread to joints, the heart, and the nervous system if left untreated.
The current standard of detection for Lyme disease is serology, which detects antibodies raised by the body in response to the disease. There is no diagnostic based on direct detection of Lyme disease-causing bacteria that is FDA cleared. The CDC recommends a two-tiered approach but the interpretation of serologic tests can be subjective, and high variability in test results has been reported between laboratories. This two-tiered approach detects two antibodies that require 1-2 weeks and 4-6 weeks to reach detectable levels, so there exists a window where diagnosis of early Lyme disease is not possible using the two-tiered method. Additionally, because antibodies can exist due to prior infections, serology’s specificity is limited.
Direct detection has the potential for clinical importance not only because a current infection by Lyme disease-causing bacteria can be determined with certainty, but because it can also deliver results faster, well inside the up to two months required for the two-tiered serology approach.
In addition, Lyme disease is significantly underreported; it is estimated that current reporting of Lyme disease cases is off by a factor of ten in the
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Gina Kent, Vault Communications
Matthew Clawson, W2O Group
Source: T2 Biosystems, Inc.