Unmet NeedLyme disease is one of many tick-transmitted diseases. Further investigation has revealed that Lyme disease is caused by the bacterium
Borrelia burgdoferi. These bacteria transmit to humans via an infected deer tick and has affected over 25,000 Americans in the United States in 2002. Currently there are estimated to be 300,000 cases a year in the U.S. The current standard treatment with 2-4 week doxycycline antibiotic treatment cures Lyme disease in 80-90% of the patients. However, about 10-20% of patients develop persisting symptoms of fatigue, pain, and neurological symptoms despite the standard antibiotic treatment, a condition called post-treatment Lyme disease syndrome (PTLDS). Current methods lack sensitivity for early stage Lime disease, where the diagnostic symptom is an EM rash, which is not conclusively demonstrated in all patients with Lyme disease. To improve the sensitivity of the current Lyme diagnosis other antigens may be supplemented with a peptide.
Technology OverviewThe inventors prepared antigens from different forms of
B. burgdorferi i.e., log phase spirochetes (LOG), stationary phase planktonic form (spirochete and round body) (SP) and biofilm-like microcolony form (MC) from stationary phase cultures, as well as water–induced round bodies, and compared their utility to diagnose Lyme disease using well characterized patient samples in a two stage design. Importantly, the inventors found that only the MC derived persister antigens (MPA) significantly improved the sensitivity of diagnosis of Lyme disease compared with the aforementioned antigens or peptide. Studies with the MPA were utilized moving forward using a second set of 140 blinded serum samples with known early Lyme or PTLDS from Johns Hopkins Lyme Disease Center SLICE studies. MPA in combination with peptide enhanced the sensitivity of diagnosis for both early Lyme and PTLDS patients.
Stage of DevelopmentThe inventors have demonstrated increased sensitivity using microcolonies of the
Borrelia burgdoferi persister antigens with and without peptide in patient serum samples. Moreover, the finding of more PTLDS patients reacting with MPA serves as a potential biomarker for PTLDS. The inventors are currently elucidating the exact antigens responsible for the improved sensitivity.
