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ASHG News

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In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs).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 Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight...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

Strengthening Evolution Education

Strengthening Evolution Education

ASHG supports the teaching of evolution in public schools, and is disappointed by Tennessee’s enactment of a bill that weakens K-12 science instruction. House Bill 38, which became law in April 2012, undermined the teaching of evolution and several other scientific topics that form the basis of public scientific literacy. Related: ASHG Statement on Tennessee... Read More

Providing Input on the Common Rule

Providing Input on the Common Rule

In response to a 2011 request for information, ASHG submitted comments on the Advanced Notice of Proposed Rule Making for “Human Subjects Research Protection: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” The Society proposed adjustments to the review, approval, and follow-up for studies that will facilitate research and improve... Read More

New Research Validates Clinical Use of Family Health History as the ‘Gold Standard’ for Assessing Personal Disease Risk

New Research Validates Clinical Use of Family Health History as the ‘Gold Standard’ for Assessing Personal Disease Risk

PRESS RELEASE Friday, October 22, 2010 Media Contact: ASHG Press Office 301-634-7346 [email protected] Experts Present Findings at ASHG 60th Annual Meeting that Provide New Insight on Patient and Physician Understanding and Use of Family Health History to Assess Disease Risk BETHESDA, MD – October 22, 2010 – Thousands of the world’s top scientists and clinicians... 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