The unmet clinical need checklist produced by the EFLM Test Evaluation Working Group (TE-WG) is a practical tool to assist the work of professionals involved in the discovery or implementation of new biomarkers. The tool is aligned with the IOM recommendations and the FDA and CE regulating body’s requirements. An interactive version of the checklist is available in this course. We encourage pilot testing and regular use of the checklist and the TE-WG would appreciate feedback which would inform future refinements of the checklist based on users’ experience.