Standardisation of concentration measurements of extracellular vesicles for medical diagnoses

Early diseases diagnosis is generally advantageous for patients compared to late-stage interventions, providing better clinical outcomes. In addition, treatment costs can be significantly lower than treatments after late-stage diagnoses. Clinicians can identify many types of diseases by testing for so-called biomarkers in various body fluid types, including blood, using the flow cytometry (FCM) technique. Extra-cellular vesicles (EVs), that are present in many body fluids, offer potential as a new biomarker. Flow cytometry (FCM) instrumentation, however, needs calibration with reference materials to make EV measurements comparable, so clinicians can be confident in this biomarker in diagnostics.

This project aimed to improve the accuracy of flow cytometry methods for extra-cellular vesicle measurements to validate this biomarker for reliable clinical use. Well-characterised, synthetic reference materials mimicking EV properties and related measurement methods will be developed to enable more harmonised FCM calibration. The project has delivered better diagnostics for patients and supported development of new measurement facilities at National Measurement Institutes and Designated Institutes across Europe.

This project builds on from EMRP project HLT02 METVES.