Oversight of Genetic Testing

In 2018, the U.S. Food and Drug Administration (FDA) invited comments on its intention to exempt a list of class II devices from premarket notification requirements, including tests assessing genetic health risks. ASHG responded to this request for comment by outlining its support for regulation that brings scientifically valid, evidence-based tests to market, and expressing... Read More

In 2015 and 2016, ASHG submitted comments to the U.S. Food and Drug Administration (FDA) on two related proposed regulations for Next Generation Sequencing (NGS)-based in vitro diagnostics. Appreciative of being engaged in the process, ASHG submitted comments to further inform and clarify the issue. Related: Comments on “Use of Standards in FDA Regulatory Oversight... Read More

In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs).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 Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight...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

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