The USDA has issued Thermo Fisher Scientific a Veterinary Biological Product License for its Applied Biosystems VetMAX-Gold MAP Detection Kit, a real-time polymerase chain reaction (PCR)-based solution designed to detect the bacterium that causes Johne’s disease. The debilitating condition costs the dairy and beef cattle industries up to $350 million each year in the United States alone.
A serious problem among production and dairy cattle worldwide, Johne’s disease is a chronic and sometimes fatal condition caused by the presence of Mycobacterium avium subsp. paratuberculosis (MAP) in the small intestine of ruminants. Diagnosis of clinical infection is usually confirmed by the detection of the causal organism in feces or in intestinal tissues postmortem.
Approval of the VetMAX Gold MAP Detection Kit is based on the successful completion of the USDA’s stringent review process to ensure safety and effectiveness of the test and evaluation of production and quality systems compliance at the manufacturing site. With the addition of this recent license, Thermo Fisher now offers six USDA-licensed molecular diagnostic tests for customers, more than any other company in the animal health space.
“We strive to provide products that will help our lab partners bring real value to their customers and help maximize their profitability,” said Martin Guillet, global head and general manager of AgriBusiness at Thermo Fisher. “With the availability of VetMAX-Gold MAP Detection Kit, labs will have the confidence they are using a functionally validated test that is subjected to ongoing quality monitoring and USDA product release requirements. This will in turn build confidence among their customers that the best tools are being used to effectively monitor and manage Johne’s disease in their herd.”