Related Policy Topics
Entities ranging from professional organizations to legislatures and agencies have created a vast body of evolving policy to guide physicians and researchers through the maze of ethical, legal and social issues surrounding genetics and molecular medicine.
AMA Science highlights some of the most pressing policy topics here:
- Genetic testing
- Regulation of genetic testing
- Genetic discrimination in employment and insurance
- Gene patenting
Genetic testing can help patients determine the likelihood of passing on or inheriting certain disorders today.
Regulation of genetic testing
Genetic tests are regulated by a both the FDA and the Centers for Medicare and Mediciad Services, which administers the Clinical Laboratory Improvement Amendments (CLIA). CLIA requires that laboratories demonstrate a test's analytic validity, i.e., that the test accurately and reliably detects the analyte in question, and requires various types of performance assessment to verify analytic validity. The FDA currently regulates only a small number of genetic tests that it considers "diagnostic test kits," which are tests consisting of multiple components that are bundled together and sold to laboratories as a unit and typically require the use of complex, non-transparent algorithms to derive results. A more detailed explanation of genetic test regulation can be found in a report developed by the Secretary's Advisory Committee on Genetics, Health, and Society.
As genetic tests become more readily available, the potential grows for discrimination against people based on their genetic information.
"Gene patenting" is a broad term referring to the patenting of either a process that involves isolation of DNA (where DNA refers to either DNA or associated materials such as RNA) as well as to a chemical substance related to DNA.