New FMD rapid kit gets license for use in U.S. livestock

First licensed FMD diagnostic kit that can be manufactured on U.S. mainland critical for rapid response in event of FMD outbreak.

The U.S. Department of Homeland Security's (DHS) Science & Technology Directorate (S&T) announced June 19 the licensing of a rapid-response (three-hour) foot and mouth disease (FMD) diagnostic kit by the U.S. Department of Agriculture's Center for Veterinary Biologics.

Developed by a large research consortium of federal agencies, academia and animal health industry scientists, this is the first licensed FMD diagnostic kit that can be manufactured on the U.S. mainland, which is critical for a rapid response in the event of a FMD outbreak, DHS said.

This diagnostic kit provides animal health first responders with an important tool to mitigate the potentially catastrophic economic and animal welfare impacts of an FMD outbreak. This high-performance test can be used for cattle, swine and sheep and will be commercialized and sold by Veterinary Medical Research & Development Inc. (VMRD), a U.S. manufacturer of veterinary diagnostics.

“This assay will be a pivotal tool for U.S. emergency preparedness and response and for ensuring the resiliency of U.S. animal agriculture -- a critical infrastructure,” DHS acting undersecretary William N. Bryan said. “Successfully bringing this test to market exemplifies the type of public/private partnership among DHS S&T, centers of excellence, government labs and commercial industry necessary to support U.S. agriculture and global FMD control and eradication programs.”

The FMD virus is highly contagious in cloven-hoofed animals, including cattle, pigs and small ruminants. Globally, FMD has a significant effect on livestock trade economics, and extensive regulatory programs exist in the U.S. to facilitate identification of, response to and control of the disease. With one in nine Americans employed in the agriculture or allied industries, the effects of an FMD outbreak in the U.S. would be devastating — with estimates at nearly $200 billion in lost revenue over 10 years across affected industries, DHS said.

This rapid, specific and sensitive FMD diagnostic assay was developed and validated over a seven-year period by a consortium of scientists at Texas A&M University and the Institute for Infectious Animal Diseases (a DHS S&T Center of Excellence) in College Station, Texas; the DHS S&T Plum Island Animal Disease Center; the USDA Animal & Plant Health Inspection Service's Foreign Animal Disease Diagnostic Laboratory, and the USDA Agricultural Research Service's Foreign Animal Disease Research Unit, as well as through a cooperative research and development agreement with VMRD.

Funding was provided by the Agriculture Defense Branch of the DHS S&T Homeland Security Advanced Research Projects Agency, Chemical & Biological Defense Division and DHS S&T Office of University Programs. DHS S&T has also granted an intellectual property license to VMRD for the test, and a patent application has been filed with the U.S. Patent & Trademark Office.

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