FDA approves Genus’ gene-edited PRRS-resistant pigs

Britain-based Genus plc has received U.S. Food and Drug Administration approval for its gene-edited PRRS-resistant pig, marking a major milestone in the company’s push toward commercialization in the U.S. pork market.

The approval clears the way for the PRRS-resistant pig, or PRP, to be used in the U.S. food supply chain. The breakthrough comes after years of research and regulatory collaboration, aimed at combating Porcine Reproductive and Respiratory Syndrome — a disease that causes significant suffering and mortality in pigs and is linked to a more than 200 percent increase in antibiotic use.

“We have spent years conducting extensive research, validating our findings and working with the FDA to gain approval,” said Matt Culbertson, Chief Operating Officer of Genus. “Today marks a major milestone for the pork industry.”

The gene edit renders pigs resistant to the PRRS virus, offering a potential game-changer for producers and a meaningful reduction in both animal suffering and the industry’s reliance on antibiotics.

“FDA approval is a fantastic achievement for Genus PIC and represents a major step towards U.S. commercialisation. We will now continue to pursue regulatory approvals in other international jurisdictions with a focus on key U.S. export markets,” said Jorgen Kokke, Chief Executive Officer of Genus.

While the FDA approval is critical for U.S. operations, Genus notes that successful commercialisation also hinges on regulatory clearance in major export destinations like Mexico, Canada, and Japan. The company is actively engaged with regulators in these countries, as well as in other markets including China.

Some countries have already given the green light to the PRP. Brazil, Colombia, and the Dominican Republic have all issued positive regulatory determinations, stating they will regulate PRP pigs the same as conventional pigs.

Genus, headquartered in Basingstoke, United Kingdom, applies biotechnology to animal breeding across the dairy, beef, and pork sectors. The PRP is one of its most notable innovations, positioning the company at the forefront of gene editing for livestock health and efficiency. With operations in over 25 countries and sales in more than 75, Genus continues to shape the future of animal agriculture through its proprietary genetics and global reach.