The United States Food and Drug Administration has approved the use of a gene-editing technology that makes pigs resistant to porcine reproductive and respiratory syndrome (PRRS) for the US food supply chain.
This landmark approval for animal genetics company Genus — using technology developed by the Roslin Institute and following years of development — helps meet the challenge of a disease that is endemic to most pig-producing regions.
The infection — which causes fever, respiratory distress and premature births — costs industry about US$2.5 billion each year in lost revenue in the US and Europe alone.
The approval follows years of close collaboration with the FDA and is a significant step on the pathway to commercialisation of gene-edited pigs in the US, and other international markets.
Technology development
Researchers at the Roslin Institute, at Scotland’s University of Edinburgh, focused their efforts on the CD163 gene in pigs.
This gene produces a receptor on the surface of cells, which the PRRS virus uses to cause infection.
Experts removed a small section of this gene, focusing on the section of the receptor that the virus attaches to, leaving the rest of the molecule intact.
Supported by Edinburgh Innovations, the University of Edinburgh’s commercialisation service, the team collaborated with Genus, who also licensed novel technologies from other institutions, to produce pigs with the specific DNA change.
The resulting pigs do not become infected with the virus, and the animals show no signs that the change in their DNA has had any other impact on their health or wellbeing.
Professor Bruce Whitelaw, of the Roslin Institute, said he was delighted to see the PRRS-resistant pig gene-edit approved for use.
“This is a milestone in the use of gene editing in livestock, and a landmark moment for the livestock industry towards managing a global disease that causes devastating losses,” Prof Whitelaw said.
Genus chief executive officer Jorgen Kokke said FDA approval was “a fantastic achievement for Genus PIC and represents a major step towards US commercialisation.”
“We will now continue to pursue regulatory approvals in other international jurisdictions with a focus on key US export markets,” Mr Kokke said.
“We have spent years conducting extensive research, validating our findings and working with the FDA to gain approval,” Genus chief operating officer Matt Culbertson said.
University of Edinburgh’s Dr Susan Bodie said this was an exciting development in translating cutting-edge research into a major solution for the food production industry.
“Gene editing — making targeted changes to DNA in a lab — allows scientists to rapidly introduce beneficial traits in plants and animals, which can take decades to achieve through traditional breeding programs,” Dr Bodie said.
Australia and New Zealand are both free from porcine reproductive and respiratory syndrome.
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