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Thermo Fisher gets USDA approval for a new Johne's test and offers a new product for labs.

New Johne's disease test approved by USDA

Thermo Fisher Scientific’s VetMAX Gold MAP detection kit uses accurate, real-time polymerase chain reaction.

A new commercially available kit to detect Johne's disease has just been approved by the USDA.

The USD) 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 condition costs the dairy and beef cattle industries up to $350 million each year in the US.

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.

Thermo Fisher says the availability of VetMAX-Gold MAP Detection Kit means labs will have the confidence they are using a functionally validated test that is subjected to ongoing quality monitoring and USDA product release requirements.

For information about VetMAX-Gold MAP Detection Kit, visit www.thermofisher.com/animalhealth.

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