Traceability of Complex Biomolecules and Biomarkers in Diagnostics - Effecting Measurement Comparability in Clinical Medicine

Short Name: CLINBIOTRACE, Project Number: T2.J.11
Stakeholders representing policy, diagnostic industry, academia and healthcare quality assessors, have highlighted the need for the further development of traceable reference measurement systems for complex biomolecules (e.g. disease state biomarkers and protein markers relevant for therapeutic intervention).

Complex biomolecules such as proteins have additional chemical and plasma-based heterogeneity so the concept of "a unique, homogeneous chemical entity" does not apply, few reference measurement methods exist, and the measurands are difficult to define.

This challenging project takes the first steps towards addressing the SI /IU debate by investigating novel methods for linking structural and functional ("activity") SI traceable measurements to the amount of protein present. If this can be realised, it will represent a very considerable advance in measurement science, providing a route to traceable complex protein measurements that will impact significantly on healthcare measurement comparability.

Other Participants
JRC - Joint Research Centre - European Commission (Europe)