Chembio Announces U.S.D.A. Approval of Tests for Detection of Bovine
Tuberculosis in Captive Elk and Deer
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,
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.
^1) Nelson et al. 2012. Evaluation of serodiagnostic assays for Mycobacterium
bovis infection in elk, white-tailed deer, and reindeer in the United States.
Veterinary Medicine International, volume 2012, Article ID 563293
^2) Waters et al. 2008. Blood culture and stimulation conditions for the
diagnosis of tuberculosis in cervids by the Cervigam assay. Veterinary Record,
Volume 163: 203-208 (http://www.ncbi.nlm.nih.gov/pubmed/18281626).
^3) Waters et al. 2011. Bovine tuberculosis in a Nebraska herd of armed elk
and fallow deer: a failure of the tuberculin skin test and opportunities for
serodiagnosis, Veterinary Medicine International, volume 2011, Article ID
About Bovine Tuberculosis
Bovine tuberculosis is a contagious and infectious granulomatous disease
caused by the bacterium Mycobacterium bovis. Although commonly defined as a
chronic debilitating disease, bovine tuberculosis can occasionally assume an
acute, rapidly progressive course. While any body tissue can be affected,
lesions are most frequently observed in the lymph nodes, lungs, intestines,
liver, spleen, pleura, and peritoneum. Although cattle are considered to be
the true hosts of M. bovis, the disease has been reported in several other
species of livestock, including bison and captive cervids. There have also
been instances of infection in other domestic and nondomestic animals, as well
as in humans. Through the National Cooperative State/Federal Bovine
Tuberculosis Eradication Program, the USDA-APHIS work cooperatively with the
nation's livestock industry and state animal health agencies to eradicate
bovine tuberculosis from domestic livestock and to prevent its recurrence.
Regulations restrict the movement of infected cattle, bison, and captive
cervids to prevent the spread of bovine tuberculosis.
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops, manufactures, licenses and markets
proprietary rapid diagnostic tests in the growing $10 billion point-of-care
testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests
are marketed in the U.S. by Alere, Inc. (formerly, Inverness Medical
Innovations, Inc.). Chembio markets its HIV STAT-PAK^® line of rapid HIV tests
internationally to government and donor-funded programs directly and through
distributors. Chembio has developed a patented point-of-care test platform
technology, the Dual Path Platform (DPP^®) technology, which has significant
advantages over lateral-flow technologies.This technology is providing
Chembio with a significant pipeline of business opportunities for the
development and manufacture of new products based on DPP^®. Headquartered in
Medford, NY, with approximately 170 employees, Chembio is licensed by the U.S.
Food and Drug Administration (FDA) as well as the U. S. Department of
Agriculture (USDA), and is certified for the global market under the
International Standards Organization (ISO) directive 13.485. For further
information please visit www.chembio.com.
Statements contained herein that are not historical facts may be
forward-looking statements within the meaning of the Securities Act of 1933,
as amended.Forward-looking statements include statements regarding the
intent, belief or current expectations of the Company and its management. Such
statements, which are estimates only, reflect management's current views, are
based on certain assumptions, and involve risks and uncertainties. Actual
results, events, or performance may differ materially from the above
forward-looking statements due to a number of important factors, and will be
dependent upon a variety of factors, including, but not limited to Chembio's
ability to obtain additional financing and to obtain regulatory approvals in a
timely manner, as well as the demand for Chembio's products.Chembio
undertakes no obligation to publicly update these forward-looking statements
to reflect events or circumstances that occur after the date hereof or to
reflect any change in Chembio's expectations with regard to these
forward-looking statements or the occurrence of unanticipated events.Factors
that may impact Chembio's success are more fully disclosed in Chembio's most
recent public filings with the U.S. Securities and Exchange Commission.
CONTACT: Chembio Diagnostics
(631) 924-1135, ext. 125
Anne Marie Fields
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