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EGAPP Working Group Meeting, May 18-19, 2005


Crown Plaza Hotel - Atlanta, GA



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Welcome and Introductions
The first EGAPP Working Group meeting was convened by Dr. Al Berg, Chair. Working Group members participating were Katrina Armstrong, Jeffrey Botkin, Ned Calonge, Celia Kaye, Kathryn Phillips, Margaret Piper, Sue Richards, Joan Scott and Steve Teutsch. Dr. Donna Stroup, Director of CDC's Coordinating Center for Health Promotion, welcomed the Working Group and reflected on the relevance of its work to key areas of emphasis for CDC.


Evaluation of Genomic Applications in Practice and Prevention (EGAPP): A Three Year Model Project
Dr. Muin Khoury, Director of the Office of Genomics and Disease Prevention, provided a historical perspective of the scientific and policy deliberations that lead to the development of the EGAPP initiative, as well as CDC's vision for an evaluation process that will, ultimately, protect the public from harm and provide health practitioners with the evidence base they need to select and use emerging genomic applications. Dr. Linda Bradley then presented an overview of the specific goals and objectives of the project.


Findings of the EGAPP Sponsored Expert Meeting in January, 2005
Dr. Bradley presented key discussion points and conclusions from the Expert Meeting on Evidence-Based Review (EBR )of Genomic Applications. Subjects addressed by this meeting included methods for collecting and evaluating data on analytic validity (assay performance), clinical validity, clinical utility (outcomes), and associated ethical, legal and social implications, as well as the process for conducting evidence reviews, developing recommendations and disseminating products. Working Group discussion was focused on determining areas of consensus and questions that required further consideration. Some key conclusions:



Engaging Stakeholders
A brief overview of the relevant stakeholders and the plans to engage them in the EGAPP process were presented. It is hoped that stakeholders will provide suggestions for high priority topics, peer review for evidence reports, technical assistance to the Working Group, advice on disseminating EGAPP products and developing informational messages for specific target audiences, and feedback on the value of the process and products.


Working Group Process
Working Group members discussed and agreed upon processes for identifying, disclosing and addressing conflicts of interest, seeking consensus and voting, and addressing minority opinions.


Working Group Deliberations
The remainder of the first meeting was devoted to initial discussions of methodology to be used for the evidence-based reviews, potential topics for review, and developing a comprehensive list of health and psychosocial outcomes to be considered for inclusion in each review. As described above, the findings of the Expert Meeting on Evidence-Based Review of Genomic Applications provided the framework for initial discussions on methodology. The Working Group also considered a number of approaches that have been used for evaluation of genetic tests, including the ACCE model ( external link & the U.S. Preventive Services Task Force process ( ). external link The Working Group agreed that their approach would need to encompass emerging tests with limited information, as a way to identify gaps in available data.


The Working Group compiled a preliminary list of potential health and social outcomes of genetic testing for individuals, families and society. It was noted that not all of the outcomes could be addressed by evidence-based methods and that, for some, data would be largely unavailable. In order to focus discussion of potential topics, the Working Group heard short presentations on three sample topics. They then deliberated on approaches for soliciting suggestions on priority topics and the criteria that would be used to prioritize topics for review.


To facilitate continuing work between meetings, each Working Group member joined one of three subcommittees. For the next meeting:


Dr. Berg thanked everyone for their participation and adjourned the meeting.

The next meeting is planned for July 18-19, 2005 in Atlanta, GA


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Historical Document
Page last updated: June 1, 2009
Page last reviewed: December 23, 2008
Content Source: OPHG Staff