ASFV, EhV & MCP EhV BioTag Testing and LAMP assay development

The U.S. Food and Drug Administration Center for Veterinary Medicine is seeking validation services for molecular assays designed to detect the viability of African Swine Fever Virus (ASFV) in animal feed and food products. The procurement involves conducting comprehensive validation experiments using BioGx, LAMP, and biosensor assays on soybean and swine complete feed with multiple inoculation levels and replicates. Contractors must possess highly specialized qualifications including a certified BSL-3 laboratory, permits to handle live ASFV specimens, expertise in animal food testing, and experience in molecular assay validation. Key deliverables include development of a validation protocol, interim reports every 60 days, and a final scientific report focusing on analytical sensitivity, sample preparation, quality control measures, and comprehensive documentation to support regulatory use. The solicitation notice was posted on August 14, 2025, with responses due by August 28, 2025.

This opportunity has no set-aside designation and is structured as a sole-source contract to be awarded to the University of Minnesota, which has been identified as the only known source possessing all required qualifications and capabilities. The base contract period runs from October 15, 2025 to October 14, 2026, with no option years included in the solicitation. The final scientific report must be delivered by October 17, 2026, providing a timeline of approximately one year for completion of all validation activities. The work will focus on ensuring the molecular assays meet regulatory standards for detecting ASFV viability in critical animal feed products, supporting food safety and animal health protection efforts. The University of Minnesota's unique combination of BSL-3 laboratory certification, ASFV handling permits, and specialized testing expertise positions them as the exclusive qualified contractor for this critical validation work.