The U.S. Food and Drug Administration (FDA) has approved Genus PIC's gene-edited pigs resistant to Porcine Reproductive and Respiratory Syndrome (PRRS) for use in the U.S. food supply chain, the company announced on April 30, 2025. This landmark decision represents a major breakthrough in agricultural biotechnology after years of research and regulatory review.
"We have spent years conducting extensive research, validating our findings and working with the FDA to gain approval," said Matt Culbertson, Genus PIC's Chief Operating Officer. "Today marks a major milestone for the pork industry."
The Global Impact of PRRS
First identified in the United States in 1987, PRRS has evolved into one of the most economically devastating diseases affecting pig production worldwide. The virus causes reproductive failure in sows and severe respiratory issues in piglets, costing the global industry an estimated $2 billion annually. In the U.S. alone, annual losses reach approximately $560 million.
The virus's frequent mutations have rendered traditional vaccines only partially effective. "The problem is that vaccines have not really helped; the virus mutated significantly," explained Elena Rice, Chief Scientific Officer at Genus, during the Animal AgTech Innovation Summit in Dallas earlier this month.
Scientific Innovation Behind PRRS Resistance
The PRRS-resistant pig technology originated from groundbreaking research conducted at the University of Missouri-Columbia and the Roslin Institute. Scientists identified the CD163 protein as the viral entry point and used CRISPR-Cas9 gene editing to remove the specific portion of the gene responsible for susceptibility.
This precise genetic modification renders pigs immune to PRRS without affecting other biological functions. Importantly, these gene-edited pigs pass the resistant trait to their offspring, enabling long-term disease control through breeding programs.
Regulatory Strategy and Commercial Rollout
Despite the FDA approval, Genus PIC has emphasized that commercial availability in the United States depends on regulatory clearances in key export markets.
"FDA approval is a fantastic achievement for Genus PIC and represents a major step towards U.S. commercialization. We will now continue to pursue regulatory approvals in other international jurisdictions with a focus on key U.S. export markets," said Jorgen Kokke, Genus's Chief Executive Officer.
Rice specifically highlighted Mexico as a critical market, stating, "We won't be broadly commercializing the PRRS-resistant pig in the U.S. until it is approved in Mexico." PRRS poses a significant challenge for Mexican producers, and Rice expressed optimism about the current Mexican administration's pro-science stance toward gene editing.
The company has completed its regulatory dossier for Health Canada and is awaiting a response. Engagements are ongoing with Japan's Ministry of Agriculture, Forestry and Fisheries (MAFF), and discussions continue with authorities in China, where producers reportedly favor a PRRS solution over one for African Swine Fever due to PRRS's greater economic impact.
Brazil, Colombia, and most recently the Dominican Republic have already issued positive determinations for the PRRS-resistant pig, meaning those countries will regulate it the same as conventional pigs.
Broader Benefits Beyond Disease Control
The potential benefits of PRRS-resistant pigs extend beyond direct disease prevention. Iowa State University research indicates that antimicrobial use in nursery pigs increases by nearly 380% during PRRS outbreaks. Recent studies cited by Genus suggest that PRRS increases the need for antibiotics by more than 200%.
"If herds can eliminate PRRS, pigs will have less need for antibiotics," according to PIC, highlighting the technology's potential contributions to animal welfare, farm economics, and antimicrobial stewardship.
Regulatory Challenges for Gene-Edited Animals
Despite the promise of this technology, gene-edited animals face a complex regulatory pathway in the United States, where CRISPR-based changes are classified as 'investigational new drugs.'
In a February 2024 Science article, UC Davis animal geneticist Alison Van Eenennaam criticized the current process: "You're talking about a very, very expensive regulatory pathway," noting that the edits involve only the animal's own DNA—changes that could theoretically occur naturally.
Nevertheless, stakeholders argue that the PRRS-resistant pig could transform animal agriculture, offering both economic and ethical gains. "There's no point having a pig get sick and die if there's an approach to genetically prevent it," said Van Eenennaam. "This benefits farmers, the pigs, and ultimately, the consumer."
As Genus PIC navigates the remaining regulatory hurdles in key export markets, this FDA approval represents a significant step forward in addressing one of the most persistent and costly challenges in global pork production.
