Biotech Updates

US FDA, NIST Collaborate To Standardize Genomic Alterations of Gene-Edited Livestock

May 24, 2023

A joint project between the United States (US) Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) will help standardize measurements for characterizing both intended and unintended alterations in genome-edited cattle and swine, thus providing developers with a roadmap to better determine intentional genetic alterations (IGAs) in animals.

The project, which was announced by the FDA on May 10, 2023, aims to provide an important new resource for researchers and companies in the field of innovative animal biotechnology who use genome editing. The resources will support the molecular characterization of genome-edited animals used for therapeutic products, agriculture, and human food use. Technology developers will have access to IGA information, such as data, protocols, potential reference materials, and measurements that NIST has generated which they can use to determine and validate methods and assays for better characterization. The resources will also be useful to regulators when evaluating animal biotech products.

Having a centralized source of IGA references can potentially reduce the time it takes for an animal biotech product at the development stage to reach the marketplace.

More information from FDA.

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