Compositions and Methods for Improved Lyme Disease Diagnosis

This CDC-developed technology entails novel compositions and methods related to the diagnosis of Lyme disease. Lyme disease, caused by the Borrelia burgdorferi bacterium, is the most common tick-borne infectious disease in the US and Europe. Diagnosis of Lyme disease is particularly challenging as symptoms often appear long after exposure. At present, the only FDA-approved diagnostic for Lyme disease involves patient blood tests for particular antibodies; these include an ELISA to measure patient antibody levels and a Western blot assay to detect antibodies specific to B. burgdorferi. One problem with the current diagnostic approach is that patient antibodies for the bacterium are not detectable until two to five weeks following the initial tick bite, and there is no way to differentiate between antibodies generated by a current infection or by a prior exposure.

This technology hinges on a unique approach that would detect whether a patient has a presently active B. burgdorferi infection. A fully developed assay based on these innovations would exploit the detection of the B. burgdorferi BbHtrA protease and/or its unique cleavage products to carry out a timely diagnosis of infection. While other direct detection methods, such as culturing, PCR and antigen capture, are often used in research laboratory settings, they have not demonstrated consistent efficacy as clinical diagnostic tools in the first few weeks following tick bite exposure. Further, despite the lack of a rapid and efficient readout for the aforementioned antibody-based Lyme disease diagnostics, there are currently no FDA-approved comparable alternatives. This technology provides a unique opportunity for rapid and accurate identification of B. burgdorferi infection, as well as distinguishing current bacterium exposure from prior exposure, thereby providing critical information to better inform treatment strategy and improve patient outcomes.