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NIH Seeks Comments on Genetic Testing Registry

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The National Institutes of Health wants to hear what the public thinks about its planned Genetic Testing Registry (GTR), which will be a resource of information for healthcare providers and patients to learn about tests and labs, and for researchers and regulators to watch the genetic testing industry.

NIH has opened a 30-day comment period on its GTR project, which will serve as a repository of information about genetic tests submitted by researchers, test developers, and manufacturers. The GTR will include information about how the tests are used, about their validity and utility, and about how they are accessed.

The database, which is expected to be running in 2011, will be overseen by the NIH's Office of the Director, and it will be developed by the National Center for Biotechnology Information.

"The registry will help consumers and health care providers determine the best options for genetic testing, which is becoming more and more common and accessible," NIH Director Francis Collins said in a statement when the program was first unveiled in March 2010.

NIH wants to receive input on the resource from a range of stakeholders including patients, test developers, test kit makers, health care providers, and researchers on the best methods for collecting and displaying information about genetic tests.

In line with recommendations from the Secretary's Advisory Committee on Genetics, Health, and Society, NIH in particular wants the registry to include information on the validity and utility of genetic tests.

Researchers, consumers, and providers will need information about the molecular basis of these tests, such as information about what the test specifically detects and what methods it uses, according to NIH.

In a request for information released on May 28, NIH outlined a number of specific areas on which it is seeking input and advice. For example, what are the potential uses for the GTR for different groups, such as researchers, payers, policy-makers, and patients? And are there any particular risks or benefits to gathering and sharing information about the availability, the scientific basis and validity, and the utility of genetic tests?

NIH also wants to know what types of data are most important to include in the site, such as data for use by researchers, consumers, health care providers, genetic testing entities, and those working with electronic health records.

In addition, NIH would like input on what processes are important to consider to make data submission easier, and which potential benefits and risks would be most likely to affect whether researchers, developers, and manufacturers submit their data to the GTR.

The effort aims to learn what information should be provided about genetic tests, such as knowledge pertaining to regulatory clearances; recommended patient populations; the test's limitations; the test's methodology; what analytes the tests measure; and how the performance of the test, such as its accuracy, sensitivity, specificity, precision, and other factors, are measured.

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