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Chembio Announces U.S.D.A. Approval Of Tests For Detection Of Bovine Tuberculosis In Captive Elk And Deer

Stocks in this article: CEMI

MEDFORD, N.Y., Jan. 29, 2013 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care diagnostic tests for infectious diseases, announces that its U.S. Department of Agriculture (USDA)-licensed products, CervidTB STAT-PAK ® and DPP ® VetTB, have been approved as primary and secondary tests for bovine tuberculosis by the USDA Animal and Plant Health Inspection Service (APHIS) in order to provide the farmed deer industry with more options for meeting the testing requirements for captive cervids (elk and deer) within the regulations.

Based on published results of independent validation studies conducted by the USDA-APHIS, the Company's tests can reliably detect the presence or absence of antibodies to bovine tuberculosis in several species of captive cervids 1). Therefore, the agency has recommended that the captive cervid regulations be amended to recognize these two tests as official tuberculosis tests. This amendment was made effective as of January 9, 2013 without prior notice and opportunity for public comment in order to immediately provide additional testing options to regulated entities that are required to have their captive cervids tested. Public comments may be submitted to APHIS until March 11, 2013. 

Commenting on this development, Lawrence A. Siebert, Chembio's Chief Executive Officer, said, "With the increased costs of producing and maintaining healthy livestock, it is vitally important to ensure that herds can be moved and processed, disease-free, in an efficient and timely manner. We welcome the USDA's designation of our CervidTB STAT-PAK ® and DPP ® VetTB as official primary and secondary tests. We believe that there is substantial potential for veterinary applications of our technology, both in production livestock as well as in companion animals, and we will continue to pursue opportunities in this important market segment."

Farmed deer constitute a significant alternative livestock industry in the U.S., with their numbers exceeding 500,000, according to a published estimate 2). The article further indicates there are an estimated two million farmed deer in New Zealand, one million in China, 400,000 in Russia and 100,000 in Canada. 

Testing for tuberculosis in cervids is currently performed using tuberculin skin tests. The single cervical test (SCT) is the primary (screening) test, whereas the comparative cervical test (CCT) is the secondary test. Limited and conflicting information is available regarding the accuracy of the skin testing in captive cervids. However, according to a published USDA study, 25/28 confirmed M. bovis-infected elk in Nebraska had false-negative results on the SCT 3). In addition, animal handling challenges resulting in high morbidity and mortality are not uncommon, as captive cervids may be required to be captured and restrained for testing up to four different times depending on test results.

Serologic testing offers the advantage over skin testing of limited animal handling, with a reduction in the associated morbidity and mortality. Chembio's tests are rapid (approximately 20 minutes to complete) and simple (one or two steps) animal-side assays that are easy to perform, provide accurate antibody detection results, and do not require laboratory environment, reading equipment, or refrigeration for long-term storage (up to 12 months). An additional advantage is eliminating the subjectivity of interpreting the skin test response at the tuberculin injection site.

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