In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs). With a focus on genetic and genomic testing, ASHG submitted comments on the proposed regulatory oversight of such tests. Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight... Read More
In 2010, ASHG issued a policy statement outlining guiding principles related to patenting and licensing in the genetic testing arena. These principles address protection of intellectual property, quality of testing, and access to testing. Related: Guiding Principles on Protection of Intellectual Property: Patenting and Licensing in the Genetic Testing Arena (April 2010) Read More
With the rise of direct-to-consumer (DTC) genetic tests – tests that are ordered directly by consumers and whose results are reported without a health provider’s involvement – ASHG issued a statement in 2007 on such tests that make health-related claims or directly affect health care decision making. The statement includes recommendations to ensure transparency, provider... Read More
In April 2000, the U.S. Secretary’s Advisory Committee on Genetic Testing issued a set of recommendations for the oversight of genetic testing. ASHG voiced general agreement with the recommendations, and provided comments from the perspective of geneticists to further clarify and refine them. Related: Comments on SACGT Preliminary Recommendations on Oversight of Genetic Testing (May... Read More
Most traits are influenced by both genetic and environmental factors. In a 1995 background statement, ASHG considers how genetic testing results should be used in insurance, if at all, as well as associated ethical and policy questions. Related: ASHG Background Statement on Genetic Testing and Insurance (January 1995) Read More