The number of Lyme disease cases in the US has been recently estimated by the CDC at 300,000 cases/year. This is major public health concern. Currently available diagnostics rely on detection of the antibody response (serology) to Borrelia burgdorferi, the causative agent of Lyme disease. However, serological tests are not accurate during the early stages of Lyme disease. Direct detection of B. burgdorferi antigens within patient samples may be the only solution to an accurate early diagnosis. This application focuses on validating the presence B. burgdorferi VlsE protein in patient samples. VlsE was recently determined to accumulate in a nonhuman primate model of Lyme disease. In addition, the project seeks to identify new diagnostic biomarkers for Lyme disease by utilizing a novel biomarker discovery platform termed, In vivo Microbial Antigen Discovery or InMAD. The overall goal is to identify multiple early Lyme disease biomarkers that can be targeted by a rapid and sensitive immunoassay.

Public Health Relevance

Lyme disease (LD) is a serious public health concern that causes disease in an estimated 300,000 US citizens annually. Diagnosis of early stage Lyme disease is very challenging. Currently, there are no effective diagnostic tests for the direct detection of Borrelia burgdorferi available. The goal of this project is to identify diagnostic biomarkers of Lyme disease and develop a prototype immunoassay.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Technology Transfer (STTR) Grants - Phase I (R41)
Project #
1R41AI114049-01
Application #
8783365
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Breen, Joseph J
Project Start
2014-07-15
Project End
2016-06-30
Budget Start
2014-07-15
Budget End
2015-06-30
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Dxdiscovery, Inc.
Department
Type
DUNS #
City
Reno
State
NV
Country
United States
Zip Code
89557