Genetic Testing
Currently, genetic tests are clinically available for more than 1,500 diseases, several hundred tests used in research, and even more in various stages of development. Most often, individuals receive genetic testing services from their healthcare providers, who may or may not be trained in genetics. Although most clinical genetic tests are offered through traditional means (e.g., healthcare providers), some genetic tests are now available directly to the consumer via the Internet.
Genetic tests are subject to regulation by several agencies within the federal government. The Food and Drug Administration regulates test kits, which represent only a handful of the more than 1,300 tests, but does not regulate laboratory-developed or “home brew” tests. Laboratories offering genetic testing must comply with regulations under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 .
Eyes on the Prize: Truth Telling about Genetic Testing
To address these issues and more, on September 20 and 21, 2007, Genetic Alliance convened a groundbreaking, truth telling summit on genetic testing, which was attended by an unprecedented mix of government, industry, and healthcare leaders. Stakeholders addressed difficult questions to capitalize on the tremendous asset of genetic testing in its many applications. The resources, materials, and discussion were distilled into recommendations for genetic testing—from development through to services. In the months following the summit, Genetic Alliance created a monograph detailing the process of the Summit, as well as the solutions and ideas that emerged from convening a diversity of stakeholders with one common goal.
Read more about the September 2007 Genetic Testing Summit.
Download and read the “Eyes on the Prize: Truth Telling about Genetic Testing” monograph.
Genetic Testing Policy Issues
As the number of genetic tests available has surged, two distinct public policy issues have arisen: genetic testing quality and the promotion of genetic testing services directly to consumers.
- Quality of Genetic Testing
- This issue encompasses the current regulatory environment, the impact on public policy, and possible policy options.
- FDA draft guidances
- CLIA genetics specialty
- Genetic Alliance Comments to SACGHS’s report on genetic testing
- Promotion of Genetic Testing Services Directly to Consumers
- This issue includes analysis of this subset of genetic testing services through the lens of genetic testing quality, the laws restricting the promotion of genetic tests and services, and the benefits and risks of direct-to-consumer promotion.
- Genetic Alliance established the Consumer Taskforce on Genetic Testing to lead the consumer community in the development of policy options.
Related Federal Legislation
- Genomics and Personalized Act of 2008 (H.R. 6498)
- Introduced by Representative Patrick Kennedy (D-RI) July 15, 2008
- Genomics and Personalized Act of 2007 (S.976)
- Introduced by Senator Barack Obama (D-IL) March 23, 2007
- Laboratory Test Improvement Act (S.736)
- Introduced by Senator Edward Kennedy (D-MA) March 1, 2007
Additional Resources:
- Genetic Testing – The Official Journal of Genetic Alliance
- Genetics & Public Policy Center
- Clinical Laboratory Improvement Amendments
- Food and Drug Administration
- Office for Human Research Protections (OHRP)
- National Office of Public Health Genomics, CDC
- Secretary’s Advisory Committee on Genetics, Health, and Society
