Clinical genetic testing and services - The US perspective

Abstract

Most clinical genetic tests in the US are laboratory developed tests and enter the market with limited oversight. • The US distinguishes research testing from clinical testing and requires CLIA-certification for the release of patient specific results. • The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) and the Collaboration, Education and Test Translation Program (CETT) are two US model programs to evaluate genetic tests.