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USDA Approves Abbott Mad Cow Disease Test

ABBOTT PARK, Ill. - Abbott Laboratories here said the United States Department of Agriculture (USDA) has given it permission to sell and distribute its bovine spongiform encephalopathy (BSE) test.

The rapid Enfer BSE test provides results within hours, is easy to use and addresses the workflow needs of USDA-approved screening laboratories, according to the company. The test detects the presence of the abnormal proteins believed to cause BSE -- commonly known as mad cow disease.

"The Enfer BSE test has been successful in Europe and Japan, where large scale screening is mandatory," said Joseph M. Nemmers, senior v.p., Diagnostic Operations, Abbott Laboratories. "As a leader in diagnostic testing and blood screening, we will continue to work with the USDA and offer this high quality test as part of an overall BSE screening solution."

Since entering into a marketing and distribution agreement in 2001 with Ireland-based Enfer Scientific Ltd., Abbott has been selling the test outside the United States and has exclusive rights to sell the test throughout the world except in Ireland. The Enfer BSE test is approved for cattle testing in the European Union and Japan.

"The rapid Enfer BSE assay tests every bovine brain sample in duplicate," said Jim Koziarz, Ph.D., v.p., research and development, diagnostics, Abbott Laboratories. "If either test result is reactive, the brain specimen is resampled and retested in duplicate. This type of testing method ensures that a true positive would be reliably detected."

More than three million samples have been tested for transmissible spongiform encephalopathies (TSEs) using the Enfer test. Additionally, Enfer Scientific is the world's largest TSE screening laboratory routinely performing up to 9,000 tests per day and providing results to beef processors within a minimum turnaround time of 12 hours.

Prior to the approval of rapid BSE tests, the USDA used an immunohistochemistry BSE test, which took several days to perform and report the results.
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