Members of the American Society of Human Genetics (ASHG) strive to further understanding of the human genome for the betterment of science, health and society. As a community of genetics researchers, ASHG is deeply concerned by the passage and implementation of Texas law S.B. 8 and the potential passage of similar bills nationwide, which will... Read More
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Tests for Genetic Diseases There are many different tests available for genetic diseases. Some people use direct-to-consumer testing to see whether they are at risk for certain genetic diseases. Genetic testing is also available through a genetic specialist or your primary care physician. In the medical setting, your doctor will first determine if you would... Read More
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In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs).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 Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight...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