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The American Medical Association and the CDC have initiated a series of physician focus groups on Lyme disease. While the findings and determinations will be published at a later time, at Galaxy Diagnostics, we are directly tackling the diagnostic challenges raised by the first focus groups.
The AMA press release on the project focused on breakdowns in trust between patients and doctors when patients with unexplained symptoms cannot access appropriate treatment. Barriers to treatment include the lack of diagnostic tools for both acute and chronic Lyme disease symptoms.
The AMA last addressed the topic in 2019, when the organization adopted a policy on vector-borne diseases that called for better surveillance and prevention as well as “new vaccines, diagnostics and treatments.”
The focus groups also follows findings from the federal Tick-borne Disease Working Group established by the 21st Century Cures Act. The Diagnostics subcommittee (including our own CEO, Amanda Elam) recommended an organized effort to promote the advancement of diagnostics, larger pools of research funding, and a national biorepository. The national biorepository would support the development of more advanced diagnostic solutions as well as clinical translation and commercialization of more sensitive and specific testing for borreliosis (the cause of Lyme disease and related conditions) and other tick-borne agents.
Importantly, the Diagnostics subcommittee also recommended the development of direct detection technology such as ddPCR, citing research by Galaxy Diagnostics scientists. Direct detection is absolutely critical in the context of persistent disease.
At Galaxy Diagnostics, we are meeting these needs. Our Lyme Borrelia Nanotrap Antigen Test brings advanced sample enrichment technology to Lyme disease testing with direct detection of Borrelia outer surface protein A (OspA) in urine. A clinical utility study of 24 patients with EM rash had 100% sensitivity for early-stage Lyme disease compared to only 74% for standard two-tier testing (Magni et al., 2015).
In the same study, the Lyme Nanotrap test showed 41% of patients tested after treatment were positive, suggesting persistent infection and the need for additional antibiotic therapy. Post-treatment Lyme disease is a diagnostically complicated condition which may be caused by continuing infection or by something else such as post-infection immune dysregulation or microbiome dysfunction. In this context, direct detection (i.e., antigen or PCR testing) is a critical diagnostic tool that can help doctors determine whether the patient requires additional treatment for infection or a different approach to resolve persistent symptoms.
Working with leading researchers in the field of emerging infectious disease and diagnostic innovation, we have moved the clinical utility of direct testing forward with published, peer-reviewed validation of our diagnostic products. At Galaxy Diagnostics, we go beyond the limits of direct detection by deploying novel sample enrichment technologies to help doctors establish a more accurate diagnosis and to deliver better patient care.
Berg, S. (2023, January 12). Lyme disease misinformation has physicians searching for guidance. https://www.ama-assn.org/delivering-care/public-health/lyme-disease-misinformation-has-physicians-searching-guidance
American Medical Association. (n.d.). Vector-borne diseases H-440.820. AMA PolicyFinder. https://policysearch.ama-assn.org/policyfinder/detail/%22Vector-Borne%20Diseases%20H-440.820%22?uri=%2FAMADoc%2FHOD.xml-H-440.820.xml
Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services. (2022, July 13). Diagnostics Subcommittee Report to the Tick-Borne Working Group. https://www.hhs.gov/ash/advisory-committees/tickbornedisease/reports/diagnostics-2022/index.html
Magni, R. et al. (2015). Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis. Journal of Translational Medicine, 13, Article 346. https://doi.org/10.1186/s12967-015-0701-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4634744/