Granted USDA License For Its
Serological Screening for TB in Elephants
New York, December
1, 2007- (OTCBB: CEMI) – Chembio Diagnostic, Inc. (OTC BB: CEMI.OB
– News) announces that it has been issued an United States Department
of Agriculture (USDA) license for its ElephantTB STAT-PAK Assay designed
to rapidly (< 20 minutes) detect tuberculosis (TB) in both Asian
and African elephants. Chembio’s other rapid serological TB assay
– PrimaTB STAT-PAK received USDA licensure earlier this year. Both
products belong to a larger family of rapid immunochromatographic assays
currently under development at Chembio for the detection of TB in animals.
Those include CamelidTB STAT-PAK, CervidTB STAT-PAK, and BovidTB STAT-PAK
Assay kits that all employ Chembio’s recently patented technology,
(U.S. Patent Number 7,192,721 – Universal Rapid Test and Method for
Detection of Tuberculosis in Multiple Host Species).
While TB has
been recognized for over 2,000 years in elephant, it has recently been
recognized as an important reemerging disease in captive elephants,
particularly Asian elephants. M. tuberculosis,
the most common cause TB classically, causes the same infection in humans
as in elephants. Transmission of TB between elephant and human (zoonoses)
has been documented.
a serious threat to captive elephants world-wide. Since 1994, TB has
been diagnosed in over 12% of the US Asian elephant population. One-fourth
(~15,000) of all the Asian elephants reside in captivity in 13 Asian
countries. The high incidence of TB among humans in Asia suggests that
many elephants within Asia may be also infected. Further information
about TB in elephant is available from Elephant Care International (www.elephantcare.org).
response to the confirmed occurrence of TB in two captive elephants,
Guidelines for the Control of Tuberculosis in Elephants were first developed
and accepted as a policy by the USDA in 1998. These same Guidelines
were again updated in 2000 and 2003. Testing elephant for TB is an essential
component of elephant health care. The veterinary care of elephant is
monitored by USDA under the Animal Welfare Act (AWA). The only available
diagnostic test for TB in elephants, until the licensure of Chembio’s
ElephantTB STAT-PAK Assay, was mycobacterial culture of trunk wash specimens,
a procedure similar to obtaining a sputum sample for TB in humans.
There is considerable
evidence that this method has poor sensitivity and can only identify
animals with extensive shedding of the organisms which typically occurs
late in the disease. Recent published studies on Chembio’s ElephantTB
STAT-PAK Assay indicate that serology is able to detect TB in elephant
as much as 4 years prior to culture of TB from trunk washes. The current
2007 proposed ElephantTB Guidelines, under review by the TB subcommittee
of the United States Animal Health Association (USAHA), recommend incorporating
Chembio’s ElephantTB STAT-PAK Assay as an integral component in monitoring
and managing TB in the US elephant population.
There is a
growing body of evidence that suggests that Chembio’s ElephantTB STAT-PAK
Assay has a wider applicability across multiple host species than just
elephants. Studies presented at the 2006 & 2007 Conferences of American
Association of Zoological Veterinarians (AAZV) utilized Chembio’s
ElephantTB STAT-PAK to detect TB in rhinos, sea lions, jaguars, and
tapirs. In these species ante-mortem TB diagnostic methods, such as
skin testing, either do not exist or are known to be less reliable.
Serology is proving to be more sensitive and easier to apply. Chembio
recognizes that the potential market for its ElephantTB STAT-PAK Assay
may, therefore be much greater than just elephants. The assay may prove
to be an effective aid in the detection of TB in a wide variety of free-ranging
and captive wildlife species in zoo conservation communities.
ElephantTB STAT-PAK Assay is a lateral flow, onsite animal side test
for the rapid detection of antibodies to TB in elephants. The test employs
a unique and patented cocktail of recombinant proteins or antigens to
both M. tuberculosis and M. bovis. The assay utilizes
whole blood, serum, or plasma in very small aliquots of 30 µl to produce
a qualitative result in less than 20 minutes.
the use of the assay in the US to only laboratories approved by state
and federal animal health officials, of which currently the only one
is NVSL (National Veterinary Services Laboratory) in Ames, Iowa. Therefore,
Chembio’s ElephantTB STAT-PAK Assay is currently commercially available
for purchase only outside the US. Contact Chembio’s website
at www.chembio.com, e-mail your request to firstname.lastname@example.org, or contact Les Stutzman at LStutzman@chembio.com for more information.
Inc., a developer and manufacturer of rapid diagnostic tests for infectious
diseases, is on the frontlines of the global battle against the AIDS
pandemic. The Company has received marketing approval from the FDA for
its SURE CHECK(R) HIV 1/2 and HIV 1/2 STAT-PAK(R) rapid tests, marketed
in the United States by Inverness Medical Innovations. The Company also
manufactures rapid tests for veterinary Tuberculosis and Chagas Disease.
In March 2007 Chembio was issued a United States patent for the Dual
Path Platform (DPP(TM)), a next generation lateral flow platform. DPP
has demonstrated significant advantages over currently available lateral
flow methods, including increased sensitivity, sample flexibility, and
please visit www.chembio.com
contained herein that are not historical
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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 are estimates only, as the
Company has not completed the preparation of its financial statements
for those periods, nor has its auditor completed the audit of those
results. Actual revenue may differ materially from those anticipated
in this press release. Such statements 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, to obtain
regulatory approvals in a timely manner, and 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.
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