In the face of increasing calls for more transparency about and regulation of genetic testing in the United States, the National Institutes of Health (NIH) announced in March that it is creating a new voluntary genetic test registry that may soon help physicians and patients select and interpret genetic tests.
Test makers can voluntarily submit information about the availability, validity, and clinical relevance of their products to the registry, which is expected to be available in 2011. The registry will be publicly searchable, allowing physicians and patients access to an array of information about genetic tests.
Currently, genetic tests are available for more than 1700 conditions. But critical information about the tests and how to use them in clinical practice is not always easy to find. Joan Scott, director of Johns Hopkins University's Genetics and Public Policy Center in Washington, DC, said that clinicians and patients need information about which tests are available, what variants the tests detect, and what the results mean in the context of an individual's medical or genetic history. For example, although some genetic tests (such as that for the variant that causes Huntington disease) may be used to determine whether an individual will develop a particular condition, others may indicate only that an individual has a higher risk of developing a condition. Additionally, these consumers need information about the evidence supporting a particular test and the reliability of the laboratory conducting the testing.
The Center and an array of other stakeholders have urged the NIH to create a genetic test registry that is mandatory rather than voluntary. But Scott called the creation of the voluntary registry a significant step. “We think it is important to do, to increase transparency about genetic tests—what is known and not known,” she said.
The NIH Office of the Director is overseeing the project, while the National Library of Medicine (NLM) National Center for Biotechnology Information will develop the registry and will cross-link it with other NLM databases on genetic and medical information. The NIH is seeking input from stakeholders on the database's design and content and will coordinate with the US Food and Drug Administration and Centers for Medicare & Medicaid Services, which already collect some information about genetic tests and/or testing laboratories.
To obtain more information or to comment on the design of the registry, visit http://www.ncbi.nlm.nih.gov/gtr/.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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