Deliverable 3.4: SOP for biomarker validation


As measurable indicators of processes happening within the body, biomarkers are a valuable source of information about a person’s health status. One of our core priorities at EPND is supporting the development of accurate biomarkers for neurodegenerative disease, paving the way for improved diagnostics and therapeutics. However, before they can be used in clinical practice, biomarker tests should be validated – to make sure they provide reliable, interpretable results.

In the EPND Standard Operating Procedure (SOP) for Biomarker Validation, experts in the field outline key parameters and protocols for the technical validation of fluid-based biomarkers. Based on an article that was an outcome of the BIOMARKAPD project, the SOP defines the following key validation parameters: precision, limits of quantification, dilutional linearity, parallelism, recovery, selectivity and sample stability.

By detailing specific procedures linked to these parameters, the SOP provides valuable guidance for researchers who are validating fluid biomarker tests in their own laboratories.

For more information, find the full “SOP for Biomarker Validation” report here.