Tetracore announced today the licensing of their VetAlert Foot and Mouth Disease Virus (FMDV) RNA Diagnostic Test Kit by the United States Department of Agriculture (USDA) Center for Veterinary Biologics (CVB).
It is one of the first licensed FMD diagnostic kits that can be manufactured on the U.S. mainland, critical for a rapid response in the event of an FMD outbreak. Additionally, this diagnostic kit provides animal health first responders with a critical tool to mitigate the potentially catastrophic economic and animal welfare impacts of an FMD outbreak.
The VetAlert FMDV RNA high-performance test kit was developed by Tetracore scientists and will be commercialized and sold by Tetracore.
Nearly two decades ago, Tetracore validated and published a real-time RT-PCR assay for FMDV, as described by Callahan et al. 2002. The primer and probe set from the publication became part of the OIE and USDA reference test methods.
“It is well-known that RNA viruses mutate and evolve, and for this reason, established PCR test designs should be periodically re-evaluated to ensure that the test designs remain fit for purpose,” says Dr. Callahan, Business Development Manager and USDA CVB liaison for Tetracore.
With this in mind, Tetracore evaluated contemporary FMD viral sequences to design a new primer-probe set that was blended with the original test to create an updated FMDV rRT-PCR, the VetAlert FMDV RNA Test Kit.
The updated test design was validated in studies with the Pirbright Institute in the UK and the National Center for Foreign Animal Diseases (NCFAD) in Winnipeg, Canada, and performed well compared to their reference test methods.