US system of oversight for genetic testing: a report from the Secretary's Advisory Committee on Genetics, Health and Society

被引:15
作者
Ferreira-Gonzalez, Andrea [2 ]
Teutsch, Steven [3 ]
Williams, Marc S.
Au, Sylvia M.
FitzGerald, Kevin T. [4 ]
Miller, Paul Steven [5 ]
Fomous, Cathy [1 ]
机构
[1] NIH, Off Biotechnol Act, Bethesda, MD 20892 USA
[2] Virginia Commonwealth Univ, Richmond, VA 23284 USA
[3] Merck & Co Inc, Whitehouse Stn, NJ USA
[4] Georgetown Univ, Washington, DC 20057 USA
[5] Univ Washington, Sch Law, Seattle, WA 98195 USA
关键词
analytical validity; CLIA; clinical decision support; clinical utility; clinical validity; genetic testing; health communication; oversight; proficiency testing; USFDA;
D O I
10.2217/17410541.5.5.521
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
As genetic testing technology is integrated into healthcare, increasingly detailed information about individual and population genetic variation is available to patients and providers. Health professionals use genetic testing to diagnose or assess the risk of disease in individuals, families and populations and to guide healthcare decisions. Consumers are beginning to explore personalized genomic services in an effort to learn more about their risk for common diseases. Scientific and technological advances in genetic testing, as with any newly introduced medical technology, present certain challenges to existing frameworks of oversight. in addition, the growing use of genetic testing will require a significant investment in evidence-based assessments to understand the validity and utility of these tests in clinical and personal decisionmaking. To optimize the use of genetic testing in healthcare, all sectors of the oversight system need to be strengthened and yet remain flexible in order to adapt to advances that will inevitably increase the range of genetic tests and methodologies.
引用
收藏
页码:521 / 528
页数:8
相关论文
共 3 条
[1]  
Alvarez Richard, 2004, Healthc Pap, V5, P33
[2]   Information systems can prevent errors and improve quality [J].
Balas, EA .
JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION, 2001, 8 (04) :398-399
[3]   Public health - A case study of personalized medicine [J].
Katsanis, S. H. ;
Javitt, G. ;
Hudson, K. .
SCIENCE, 2008, 320 (5872) :53-54