EuroGentest Clinical Utility Gene Card (CUGC)
A standardised template that summarises evidence on how useful a genetic test is for a specific disease or gene, helping doctors, labs, and health systems decide whether to use it.
At a glance
Use when
Developing or evaluating genetic tests; informing clinical guidelines or reimbursement decisions in Europe
Avoid when
Rapidly evolving tests with insufficient evidence; non-genetic or broad genomic screening without gene-specific focus
Inputs
Genetic test characteristics, disease-specific data, evidence on analytical and clinical validity, clinical utility studies, ELSI data
Outputs
Structured gene/disease-specific report summarising validity, utility, and recommendations for use
How it works
Structured template based on the ACCE framework (Analytical validity, Clinical validity, Clinical utility, Ethical, legal and social implications), developed by EuroGentest and ESHG to assess and communicate the clinical utility and validity of genetic tests in a harmonised way across Europe.
- HTA domains
- Clinical Effectiveness, Organisational aspects, Patient and Social Aspects
- Assumptions
- Evidence is available and sufficient to assess test validity and utility; test is gene- or disease-specific
- Strengths
- Standardised, comprehensive framework; promotes transparency and consistency across Europe; integrates ELSI aspects
- Limitations
- May not cover all rare variants or population-specific factors; dependent on availability and quality of evidence
- Also known as
- CUGC, Clinical Utility Gene Card
Questions this answers
- › What is the analytical validity of the genetic test?
- › What is the clinical validity and utility of the test?
- › What are the ethical, legal, and social implications (ELSI) of using the test?
- › How does the test impact patient management and outcomes?
- › What are the recommendations for test use in clinical practice?
- › Who should be tested and under what circumstances?
References & sources
Similar by meaning
- MSAC evaluation framework for genetic and genomic tests (value-of-knowing / personal utility)
- ACCE Model Process for Evaluating Genetic Tests
- Emerging Screening Criteria (Andermann synthesis of Wilson-Jungner)
- GRADE for Diagnostic Tests and Strategies
- Validation of the cancer-specific utility measure EORTC QLU-C10D using evidence from four lung cancer trials covering six country value sets
Beta record. Based on the original catalogue summary; primary-source enrichment pending.