Professional Guidance

Regulation of Laboratory-Developed Tests

Regulation of Laboratory-Developed Tests

In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs).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 Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight...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

Considering Family Privacy in Genetic Research and Medicine

Considering Family Privacy in Genetic Research and Medicine

Genetic information about an individual reveals genetic risk information about both the individual and other family members. ASHG issued a statement in 2000 considering the importance of family medical history in genetics research and its balance with ensuring the genetic privacy of research participants’ relatives, and one in 1998 commenting on this balance in the... Read More

Understanding Behavioral Genetics

Understanding Behavioral Genetics

Behavioral genetics brings to light both genetic and environmental influences on behavior. ASHG commented on the state of this field, including recent accomplishments, future directions, and methods, in a 1997 statement. Related: Statement: Developments in Human Behavioral Genetics: Past Accomplishments and Future Directions (June 1997) Read More

Analyzing Genetic Testing in Adoption

Analyzing Genetic Testing in Adoption

In 2000, recognizing the potential for increased use of genetic testing in adoption, ASHG and the American College of Medical Genetics issued recommendations for its use in newborns and children, keeping the best interests of the child paramount. This followed a brief 1991 report on points to consider related to genetics and adoption. Related: Statement... Read More

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