文献_2009-The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative.pdf

ARTICLE The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative: methods of the EGAPP Working Group Steven M. Teutsch, MD, MPH1 2 3 , Linda A. Bradley, PhD , Glenn E. Palomaki, BS , James E. Haddow, MD3 4 5 2,6 , Margaret Piper, PhD , Ned Calonge, MD, MPH , W. David Dotson, PhD , Michael P. Douglas, MS2,6 7 , and Alfred O. Berg, MD, MPH , Chair, on behalf of the EGAPP Working Group The Evaluation of Genomic Applications in Practice and Preven- dresses the previously proposed6,7 components of evaluation: tion (EGAPP) Initiative, established by the National Office of Public Analytic and Clinical validity, Clinical utility and associated Health Genomics at the Centers for Disease Control and Preven- Ethical, legal and social implications. The ACCE Project ex- tion, supports the development and implementation of a rigorous, amined available evidence on five genetic testing applications, evidence-based process for evaluating genetic tests and other providing evidence summaries that could be used by others to genomic applications for clinical and public health practice in the formulate recommendations.13–16 Systematic reviews on genetic United States. An independent, non-federal EGAPP Working tests have also been conducted by other groups.17–20 Group (EWG), a multidisciplinary expe