Biomarker Research
The search for reliable biomarkers in ME/CFS has been a central focus of research for decades. The 2024 NIH deep phenotyping study by Walitt et al. represents a landmark contribution to this effort, identifying multiple objective biological abnormalities that distinguish PI-ME/CFS patients from healthy controls (Walitt et al. 2024). This chapter reviews the current state of biomarker research, synthesizes findings across multiple biological domains, and discusses the path toward clinically useful diagnostic and prognostic markers.
For patients: read the key-biomarkers-from-the-NIH section to see which objective abnormalities have been documented, and the composite-panels section for how markers may combine into a test.
For caregivers: read the overview-of-biomarker-development and composite-panels sections to understand the state of diagnostic testing.
For clinicians: read the biomarker sections relevant to your practice (metabolomic, immunological, neurological) and the composite-panels section to understand what testing is and is not yet available.
For researchers: read all biomarker sections for the evidence base, the overview-of-biomarker-development for the path to validation, and the composite-panels section for multi-marker approaches.
1 Contents
- Overview of Biomarker Development
- Key Biomarkers from the NIH Deep Phenotyping Study
- Metabolomic Biomarkers
- Immunological Biomarkers
- Neurological Biomarkers
- Genomic and Epigenetic Biomarkers
- Proteomic Biomarkers
- Composite Biomarker Panels
- Functional Biomarkers
- Clinical Workup Biomarkers: Exclusion and Comorbidity
- Biomarker Validation and Standardization
- Pain Registries and Databases as Biomarker Data Sources
- Emerging Biomarker Candidates from Parallel Multi-Modal Studies (2025β2026)
- Summary: Current State and Future Directions
- Architecture C Diagnostic Concepts
- HSAT2 and HERV-K Exosomal Biomarkers
- ISR Biomarker Panel: Tissue-Specific Integrated Stress Response Readouts
- Connective Tissue and ECM Biomarkers
- Exosome-Based Biomarkers
- Inflammation Source-Registry Biomarker Proposals