Genomic Translation

ACCE Model Process for Evaluating Genetic Tests

From 2000 – 2004, CDC’s Office of Public Health Genomics (OPHG) established and supported the ACCE Model Project , which developed a process for evaluating scientific data on emerging genetic tests. Analytic validity; Clinical validity; Clinical utility; and Ethical, legal, and social implications (ACCE) is the first publicly-available analytical framework specifically developed to evaluate genetic tests. The ACCE framework has guided or been adopted by various entities in the United States and worldwide for evaluating genetic tests.

The ACCE process includes collecting, evaluating, interpreting, and reporting data about Deoxyribonucleic acid (DNA) (and related) testing for disorders with a genetic component. These data are organized in a format that allows policymakers to access up-to-date and reliable information for decision making, and that can be applied flexibly by different stakeholders to different genetic test scenarios.

An important by-product of the ACCE model process is the identification of gaps in knowledge that will help to define future research agendas. The CDC-supported EGAPP initiative builds on the ACCE model structure and experience.

The ACCE acronym represents the four main criteria for evaluating a genetic test:

1. Analytic validity: How accurately and reliably the test measures the genotype of interest.
2. Clinical validity: How consistently and accurately the test detects or predicts the intermediate or final outcomes of interest.
3. Clinical utility: How likely the test is to significantly improve patient outcomes.
4. Ethical, legal, and social issues that may arise in the context of using the test.

The ACCE model process is composed of a standard set of 44 questions that address disorder, testing, and clinical scenarios, as well as analytic and clinical validity, clinical utility, and associated ethical, legal, and social issues.

Read more about the ACCE Initiative in the decade report (10 Years of Public Health Genomics at CDC 1997 - 2007).