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  1. Advancing Regulatory Science

Redefining the paradigm for Lyme disease diagnosis and therapeutics

CERSI Collaborators: Thomas Grys, PhD, D(ABMM); Crystal Grys, DNP, RN; Molly Jeffery, PhD; Joseph Ross, MD, MHS

FDA Collaborators: Sara Brenner, MD, MPH; Kristen Honey, PhD, PMP; Pooja Jani, MD, MPH; Joseph Meree, MS; Jules Nchoutmboube, MS, PhD

Project Start Date: September 1, 2024

Regulatory Science Framework

Primary Charge: II. Strengthen post-market surveillance and labeling of FDA-regulated products: G. Efforts to Harmonize Existing and Emerging Data Standards
Secondary Charge: I. Modernize development and evaluation of FDA-regulated products​: F. Complex and Novel Clinical Trial Design​

Regulatory Science Challenge

Lyme disease is caused by a bacterium, Borrelia burgdorferi, that is transmitted through the bite of a tick. The bacterium does not grow well in culture and the antibodies produced against it can remain in the body for months to years. These factors can make it difficult to diagnose the disease in some patients. For the same reasons, it can be difficult to design new testing methods.

Project Description and Goals

This project extends the impact of the HHS LymeX Innovation Accelerator and broadens FDA’s Diagnostic Data Program (DxD) because of the potential to advance data-driven insights from diagnostic tests that may benefit diverse patient populations diagnosed with Lyme disease. Researchers plan to develop a new “LymeX data schema” for Lyme disease diagnostics and make this data schema publicly available for clinical trials in collaboration with stakeholders, including HHS LymeX partners and teams participating in the LymeX Diagnostics Prize.

Anticipated Outcomes/Impact

  • New LymeX data schema for clinical trials that will be made public in an open-source format such as REDCap. The LymeX DxD data schema will support documentation of the broad manifestations of all stages of Lyme disease, including Post-Treatment Lyme Disease Syndrome (PTLDS) and Lyme-Infection Associated Chronic Illness (IACI).
  • Scientific synthesis and non-technical summaries of lessons learned from the LymeX program with insights grounded in data and digital interoperability for disease-agnostic extensibility and scalability through the new LymeX DxD data schema. The availability and adoption the LymeX data scheme across IACIs will provide a common approach for data collection to inform diagnostic approaches and treatment studies. These findings will be shared with the clinical, scientific, research, and regulatory communities.

 

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