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Policy and Ethics Issues

The growing availability and use of genetic testing in the clinical setting raises a number of ethical, legal and social issues and questions that healthcare providers should become familiar with. For example, how should such tests be regulated? Should "home brew" tests be regulated by the FDA just like diagnostic devices? What level of analytical validity (accuracy of the test result), clinical validity (use of the test as a diagnostic tool), or clinical utility (use of test result for treatment) should be required for tests offered to the public? What counseling should be provided for recipients of test results, and who should provide that guidance? How can the public be protected from discrimination? This section provides healthcare professionals with links to more detailed information about the ethical, legal and social challenges that accompany genetic testing.

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Last Reviewed: May 2, 2012