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Compositions and Methods for Improved Lyme Disease Diagnosis
Case ID:
TAB-2800
Web Published:
12/6/2022
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.
Patent Information:
Title
App Type
Country
Serial No.
Patent No.
File Date
Issued Date
Expire Date
Direct Link:
https://canberra-ip.technologypublisher.com/tech/Compositions_and_Methods_for _Improved_Lyme_Disease_Diagnosis
Keywords:
BACTERIA
BORRELIA BURGDORFERI
BORRELLIA
BURGDORFERI
CDC Docket Import
CDC Docket Import CDC Prosecuting
Compositions
DA3XXX
DAXXXX
diagnostic
Diagnostic assay
diagnostic in vitro
Disease
DXXXXX
ivd
LYME
Methods
Relating
TICK
TICK-BORNE
TICKS
Vector-borne
Vector-borne diseases
VETERINARY
VJXXXX
VOXXXX
WBXXXX
WCXXXX
WDXXXX
WFXXXX
WIXXXX
WMXXXX
XCXXXX
YBXXXX
Zoonotic
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For Information, Contact:
Jeremiah Mitzelfelt
LPM
NIH Technology Transfer
301-443-8518
jeremiah.mitzelfelt@nih.gov