Early Lyme Disease Detection
Available for Licensing
US Utility Patent: US 10669567 B2
John T Belisle
Claudia R Molins
Gary P Wormser
At A Glance
Researchers at Colorado State University have developed and patented a metabolic biosignature based on small molecule metabolites of serum for the diagnosis of early Lyme Disease. The biosignature consists of more than 44 molecular features (metabolites) that correctly diagnosed early Lyme patients and healthy controls with a sensitivity of 88% (84-95%) and a specificity of 95%. This is in comparison to the current CDC recommended diagnostic that correctly diagnoses the same patient group with 37-44% sensitivity and 95-100% specificity.
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Lyme disease (LD), caused by Borrelia burgdorferi, is the most commonly reported tick-borne disease in the United States and Europe. Recent studies suggest that 300,000 cases of LD may occur in the United States each year. Antibody-based diagnostics for LD are widely utilized in clinical practice, and the Centers for Disease Control and Prevention (CDC) recommends a 2-tier approach for serologic testing. The detection of antibodies to B. burgdorferi is highly specific and sensitive in patients with late manifestations of LD; however, the sensitivity in patients with early LD is unsatisfactory (29%–40%). Direct diagnostic testing using culture or nucleic acid amplification on peripheral blood samples also has low sensitivity (≤50%) for early LD. Thus, the diagnosis of early LD is usually based on recognition of the most common clinical manifestation, an erythema migrans (EM) skin lesion. Other skin lesions, however, such as tick-bite hypersensitivity reactions, STARI (southern tick associated rash illness), and certain cutaneous fungal infections, can be confused with EM.
- Ability to distinguish between active and inactive Lyme Disease
- Increased sensitivity without changing specificity
- Detection early Lyme Disease
Molins, Claudia R, et al. “Development of a Metabolic Biosignature for Detection of Early Lyme Disease.” Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, Oxford University Press, 15 June 2015, www.ncbi.nlm.nih.gov/pubmed/25761869.
Last updated: May 2020