LYME DISEASE DIAGNOSTICS
First discovered in Lyme, Connecticut 40 years ago, Lyme disease has spread rapidly throughout the Eastern, Midwest and Pacific regions of the North America., Europe and Asia. It now currently afflicts over 300,000 people per year in the U.S. alone, making it the sixth most commonly reported infectious disease in the U.S. Clinical diagnosis of Lyme disease is difficult as the identifying erythema multiforme (EM) rash is only present in 60 to 80 percent of cases and practicing physicians may not be properly trained in identifying disease symptoms. Assessments of the antibody response to Borrelia burgdorferi (Bb) infection has been the primary tool for diagnosis of Lyme disease. These tools have been in place for over 20 years in the U.S. and in Europe since 1995. These tests have low sensitivity early in infection and do not distinguish previous exposure from active infection. The sensitivity of two-tiered testing ranges significantly from 30 percent in the early-stages of the disease to nearly 100 percent in late stage disease. Variability in sensitivity has also led to confusion and misunderstanding of the value of testing and how to interpret results. Lyme disease, if not diagnosed early, can lead to serious health problems including arthritis, nervous system impairment, and heart failure.
The winning team will develop a Lyme disease diagnostic that demonstrates significant specificity and sensitivity; detects Borrelia burgorferi and other Lyme disease-causing Borrelia genospecies; is administered at point of care (e.g., at or near where the patient is located); delivers a positive/negative result within one hour (60 min); and delivers results that are understandable by a lay person.
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