TITLE:
PathoDNA, an Advanced Diagnostic for Lyme Disease & Co-Infections Utilizing Next Generation DNA Sequencing with Greater Sensitivity and Selectivity than ELISA/Western Blot
AUTHORS:
Robert Schettig, Ruth Tan-Lim, Daniel Warren, Zachary Poteet, Rory Sears, Michael Hummel, Connor Coffin, Kendra Quart, Christopher Aussems, Ronald Matthias Jr., David Medina, Matthew Klein, Gayle Roberts, John C. Oertle III, Dino Prato
KEYWORDS:
Lyme Disease, Ticks, Tick-Borne, Borrelia, Sequencing, Diagnosis
JOURNAL NAME:
Advances in Infectious Diseases,
Vol.11 No.4,
December
14,
2021
ABSTRACT: The controversial subject of chronic Lyme disease has occupied medical discourse for years while contributing to unprecedented patient suffering in the United States and abroad. A general misunderstanding of Lyme disease and overconfidence in the Center for Disease Control’s (CDC) recommended two-step test for Lyme disease has led to misdiagnosis and incorrect treatment over the years. This leads to increasing medical expenses and worse outcomes for patients. The two-step test, an ELISA immunoblot followed by a confirmatory Western blot, yields accuracy rates as low as 29% for acute Lyme disease and 75% for chronic Lyme disease. While these practices have been a staple of microbiology for decades, these accuracy rates are unacceptable for diagnostic tests when better technology is available. PathoDNA, a Next-Generation DNA sequencing test for Lyme disease and other tick-borne pathogens, achieves accuracy rates of 98% for B. burgdorferi and 95% or greater for other common tick-borne pathogens with superior sensitivity and selectivity. PathoDNA is a Clinical Laboratory Improvement and Amendments (CLIA)-validated laboratory test that achieves these results utilizing Next Generational DNA Sequencing and a proprietary bioinformatics database. Thus, it allows for rapid results and specific identification of tick-borne illnesses. In this article, we will compare this promising technology against the existing standards for diagnosing and testing Lyme disease. We believe that PathoDNA can set a new standard for identifying Borrelia and diagnosing Lyme disease along with other tick-borne infections.