Genetic Testing

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In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs).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 Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight...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

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