What is EGAPP?
The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) is a project launched in 2004 by the Centers for Disease Control and Prevention (CDC) to put selected genetic tests to the test. Hundreds of genetic tests, which could give information about susceptibility to major diseases such as cancer, diabetes and heart disease, are in development. It is important for the public health community that a reliable method, based on reliable scientific evidence, be found for evaluating these tests. The EGAPP project is a key step.
EGAPP follows in the footsteps of an earlier CDC-funded project, ACCE. The ACCE project took its name from four key components of test evaluation - analytic validity, clinical validity, clinical utility, and associated ethical, legal and social implications. Evaluating five genetic tests between 2000 and 2004, ACCE served as a model for investigating the availability and quality of data on the safety and effectiveness of all DNA-based genetic tests.
Building on the knowledge gained from the ACCE project and existing U.S. recommendations for action, CDC started the EGAPP project. The intent is to both objectively assess selected tests and also to begin developing a model process for assessing all genetic tests in the future. An independent, non-federal, multidisciplinary working group is the focus of EGAPP. This working group is comprised of 13 people from the U.S. with expertise in areas such as evidence-based review, clinical practice, public health, laboratory practice, genomics, and health technology assessment.
EGAPP focuses on the process of assessing new genetic tests for their safety and usefulness. Outcomes to be considered include benefits and harms to the patient and family, as well as societal and public health issues (e.g., availability or access to testing, and adequacy of consumer and provider education).
EGAPP is commissioning evidence-based reviews of selected tests that have the potential for broad application and health impact. Genetic tests selected for review include ones that predict response to therapy, detect susceptibility for a disease in family members, or predict risk of certain diseases in healthy populations. In late 2005 EGAPP began evaluating genetic tests related to depression, colorectal cancer, and ovarian cancer. Evaluations of more tests began in the summer of 2006 and continue on as new tests come to the fore.
All of the evidence-based reviews conducted for EGAPP include assessments of available information on analytic and clinical validity, and the impact of testing and subsequent interventions or treatments. The EGAPP working group publishes Evidence Reports on all its findings. Evidence-based reviews, which involve the systematic assessment of all of the current published, relevant medical literature, can include clinical trials and other studies of interventions. EGAPP also will consider emerging tests with limited information, as a way to identify gaps in available data.The EGAPP working group includes not only assessments of certain tests, but also reports on its methodological approaches to evaluating the selected tests.