Statement Archive

Addressing Innovation in Prenatal Screening

Addressing Innovation in Prenatal Screening

Following rapid innovation in non-invasive prenatal testing (NIPT), ASHG and the European Society of Human Genetics published a joint statement in the European Journal of Human Genetics that addressed the responsible use of these tests across conditions and how they might fit with existing approaches. Related: Statement: Non-invasive Prenatal Testing for Aneuploidy and Beyond: Challenges... 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In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs).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 Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight...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

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

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

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