Genetic Testing

ASHG Opposes H.R.1313, the Preserving Employee Wellness Programs Act

Media Contact: Nalini Padmanabhan ASHG Communications Manager 301.634.7346 press@ashg.org For Immediate Release Wednesday, March 8, 2017 8:30 am U.S. Eastern Time Bill Would Undermine Genetic Privacy Protections BETHESDA, MD – The American Society of Human Genetics (ASHG) opposes H.R.1313, the Preserving Employee Wellness Programs Act, introduced on March 2 and scheduled for markup by the... Read More

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In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs).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 Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight...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

Advising on Patenting and Licensing in Genetic Testing

Advising on Patenting and Licensing in Genetic Testing

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

Commenting on Consumer Genetic Testing

Commenting on Consumer Genetic Testing

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

Advising on Oversight of Genetic Testing

Advising on Oversight of Genetic Testing

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