Some infectious diseases are very difficult to diagnose accurately. Lyme disease is a perfect example. While there are approximately 30,000 cases of Lyme disease reported each year, remarkably, the CDC now estimates the approximate number of cases in the U.S. at 300,000 per year. This is a major public health concern.
The discrepancy between the reported and estimated number of actual cases is largely due to the limitations of current diagnostics. 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 and can yield negative test results when the disease is actually present. Direct detection of B. burgdorferi antigens within patient samples may be the only solution to an accurate early diagnosis.
The goal is to identify multiple biomarkers that can be targeted by a rapid and sensitive immunoassay for early diagnosis of Lyme disease. Recently a B. burgdorferi protein, VlsE1, a potential early biomarker of Lyme disease was found to accumulate during infection in nonhuman primates. Diagnostics Discovery Laboratory, in collaboration with researchers at DxDiscovery and Tulane National Primate Research Center, will validate the presence of VlsE1 in human patient samples and identify new diagnostic biomarkers for Lyme disease by utilizing a novel biomarker discovery platform termed, In vivo Microbial Antigen Discovery (InMAD).
Project Investigators: David AuCoin, Ph.D. (Principal Investigator), Monica Embers, Ph.D. (Principal Investigator, Tulane National Primate Research Center), Mario Philipp, Ph.D. (Principal Investigator, Tulane National Primate Research Center), and Mark Hubbard Ph.D. (Co-Investigator, DxDiscovery, Inc.)
Grant support: This study is supported by a Small Business Technology Transfer (STTR) NIH grant (R41AI114049), Identification of Borrelia burgdorferi diagnostic biomarkers in humans and nonhuman primates, 2014-2016.