Standardisation of measurements of neurodegenerative disease biomarkers

Neurodegenerative diseases (NDD) pose a significant economic and social burden in Europe, with Alzheimer’s disease (AD) and Parkinson’s disease having an economic cost of approximately €9 million in 2022.

Earlier diagnosis and more accurate prognosis through detection of biomarkers in body fluids could improve the management of NDD conditions. However, application of NDD biomarkers in clinical settings is currently obstructed by a lack of standardised measurement procedures. Additionally, there is a need to move the detection of established biomarkers from cerebrospinal fluid (CSF) to blood to allow for easier sample collection.

This project aims to develop new certified reference materials and reference measurement procedures to allow for accurate and standardised measurements of the AD markers phosphor-tau in plasma, and for neurofilament light chain in blood or serum. Furthermore, clinical measurement procedures will be defined to ensure that even in early developmental stages, novel NDD biomarker assays are presenting the needed metrological traceability.

Implementation of NDD biomarker assays will be supported through the development of uncertainty frameworks and protocols. New structural approaches to aid in the discovery and standardisation of NDD biomarkers will be defined to address metrological challenges affecting the detection of biomarkers, including protein conformational states and post-translational modifications. Additionally, SI-traceable detection methods for established NDD biomarkers will be transferred from CSF to blood by developing new reference method procedures.

The results of the project are expected to allow simpler, cheaper and earlier diagnosis of NDD conditions in patients and help reduce the social and economic cost of these forms of disease.