MARK-ME – Minimal Biomarker Panels for Diagnosis and Stratification of ME/CFS

The diagnosis of ME/CFS is currently based on established clinical criteria; objective diagnostic biomarkers are not yet available. However, biomarkers could complement clinical diagnosis by enabling standardised patient classification, reducing diagnostic uncertainty and delays, and serving as objective measures for clinical trials. Biomarkers are also gaining importance as research indicates biological heterogeneity in ME/CFS, with immunological dysregulation and autoimmune mechanisms playing a central role in a subset of patients. The project aims to develop minimal biomarker panels for the diagnosis and biological stratification of ME/CFS patients. Building on existing high-dimensional immune and proteomics data, machine learning methods will be used to identify biomarker combinations that offer the highest possible diagnostic performance. Complex biological signatures will be reduced to a small number of informative biomarkers, and the study will assess whether these panels enable reliable diagnosis and allow for biological stratification into clinically relevant endotypes (patient groups characterised by distinct biological disease mechanisms). This approach aims to lay the groundwork for more objective diagnostics and more targeted treatment decisions. The project results are intended to form the basis for further analytical and clinical validation, as well as for regulatory development into an in-vitro diagnostic (IVD) product. In doing so, the project aims to make a significant contribution to improving diagnostics and to establish a foundation for future personalised treatment of ME/CFS.