A critical unmet need
Lyme disease presents a diagnostic challenge due to the overlap in symptoms with other disease conditions. If detected early, antibiotic treatment can be highly effective. However, as the disease progresses, treatment can become more challenging.
Traditionally, patients are tested for antibodies to Borrelia burgdorferi, the Lyme spirochete, by a screening test, with results confirmed by immunoblot. This approach has been shown to be insensitive in early stages of Lyme disease. In addition, immunoblot is a subjective, labor-intensive method with limited availability. More recently, the immunoblot has been substituted by a second ELISA in the Modified Two-Tier Protocol (MTTT), but this approach is still not reliable enough to diagnose the earliest stage of disease, when patients may present with an erythema migrans rash.
