ACCE Model Process for Evaluating Genetic Tests
The ACCE Model helps evaluate genetic tests by looking at how accurate they are, how well they predict disease, how useful they are for patients and doctors, and what ethical or social issues they might raise.
At a glance
Use when
Evaluating new or existing genetic tests for potential clinical or public health implementation.
Avoid when
Rapid, preliminary screening is needed with limited data or resources.
Inputs
Genetic test characteristics, epidemiological data, clinical outcome data, ethical and legal context.
Outputs
Structured evaluation report assessing analytic and clinical validity, clinical utility, and ELSI implications of a genetic test.
How it works
The ACCE Model Process, developed by the CDC Office of Public Health Genomics and Burke et al., is a structured framework for evaluating genetic tests across four domains: Analytic validity, Clinical validity, Clinical utility, and Ethical, legal, and social implications (ACCE). It includes 44 specific questions designed to systematically assess each domain, supporting evidence-based decision-making in genomic medicine.
- HTA domains
- Clinical Effectiveness, Safety, Patient and Social Aspects
- Categories
- AppraisalHeterogeneity
- Assumptions
- High-quality evidence is available for each domain; stakeholders will use the framework systematically; ethical considerations are integral to test evaluation.
- Strengths
- Comprehensive coverage of technical, clinical, and ethical aspects; promotes transparent, multidisciplinary assessment; widely recognized and cited in genomic policy.
- Limitations
- May require significant data and expertise to apply fully; not all questions may be equally relevant across different test types or settings.
- Also known as
- ACCE Framework, ACCE Model
Questions this answers
- › Does the test accurately detect the genetic variant (analytic validity)?
- › Is the genetic variant reliably associated with the disease (clinical validity)?
- › Does using the test lead to improved health outcomes (clinical utility)?
- › What are the ethical, legal, and social risks of implementing the test?
- › Are the benefits of the test greater than the potential harms?
- › How should genetic information be communicated and used responsibly?
References & sources
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.