|
 (152KB) |
 |
What Is the Public Health Issue?
- The success of the Human Genome Project has led to
increasingly rapid translation of genomic information
into clinical applications. Most of the more than 900
genetic tests available for clinical testing are used
for diagnosis of relatively rare single-gene
disorders, but a growing number have population-based
applications and the potential for broad public health
impact.
- Issues raised about genetic testing include the
need to develop evidence to establish efficacy and
cost-effectiveness before tests are commercialized.
Increasing demand for new applications of genomic
technology creates an urgent need for timely and
reliable information that allows health-care providers
and consumers to use tests appropriately.
- Recommendations for developing and overseeing safe
and effective genetic tests have been made by expert
panels such as the NIH-DOE Task Force on Genetic
Testing and the HHS Secretary’s Advisory Committee on
Genetic Testing (SACGT). However, a coordinated
approach for the effective translation of genomic
applications into clinical practice and health policy
is needed.
What Has CDC Accomplished?
In 2004, CDC launched a new initiative—a model project
entitled Evaluation of Genomic Applications in Practice
and Prevention (EGAPP). The EGAPP Project aims to
develop and evaluate a coordinated, systematic process
for assessing genomic applications (i.e., genetic tests
and other applications of genomic technology) in
transition from research to clinical and public health
practice. A CDC-wide and HHS interagency Steering
Committee provided early guidance and will consider how
to use the knowledge gained by the project to develop a
sustainable assessment process. An independent,
non-federal, multidisciplinary EGAPP Working Group was
established in April, 2005. The roles of this 13-member
panel are to prioritize and select genomic applications
for evaluation, establish methods and process, monitor
expert and peer review of commissioned evidence reports,
and develop conclusions and recommendations based on the
evidence. The EGAPP Working Group has developed methods
and criteria for topic selection and commissioned
evidence reviews on four topics in late 2005.
Dissemination of evidence reports and recommendations is
expected to begin in fall 2006.
What Are the Next Steps?
Two topics for review in 2006 were recently selected.
Other planned EGAPP activities include engagement of
stakeholders in the development of targeted
informational messages based on the evidence and EGAPP
Working Group recommendations, and an evaluation of the
value and impact of the project’s processes and products
scheduled to begin in mid 2007. |
For additional information on this or other CDC programs, visit
www.cdc.gov/genomics
September 2006 |
|