SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
Date
of
Report (Date of earliest event reported) December
8, 2005
CHEMBIO
DIAGNOSTIC, INC.
(Exact
name of registrant as specified in its charter)
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Nevada
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0-30379
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88-0425691
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(State
or other jurisdiction
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(Commission
File Number)
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(IRS
Employer
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||
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of
Incorporation)
|
Identification
Number)
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|||
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3661
Horseblock Road
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Medford,
NY 11763
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(Address
of principal executive offices)
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631-924-1135
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(Registrant’s
Telephone Number)
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N/A
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
7.01. Regulation FD Disclosures.
(a)
On
December 8, 2005 the Registrant issued the press release titled “Detecting
Tuberculosis in Wildlife: Chembio Rapid Diagnostic Test Recommended for Approval
by United States Animal Health Association” included herein as Exhibit
99.1.
ITEM
9.01. Financial Statements and Exhibits
(c)
Exhibits.
99.1
Press
Release titled “Detecting
Tuberculosis in Wildlife: Chembio
Rapid Diagnostic Test Recommended for Approval by United States Animal Health
Association”
issued
December 8, 2005.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
Date:
December 8, 2005 Chembio
Diagnostics, Inc.
By:
/s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1 Press Release
Detecting
Tuberculosis in Wildlife:
Chembio
Rapid Diagnostic Test Recommended for Approval by United States Animal Health
Association
MEDFORD,
N.Y. - (MarketWire) - December 8, 2005—Against a backdrop of mounting concern
about the steady increase in animal to human transmission of tuberculosis
(TB)
and other communicable diseases, Chembio Diagnostics, Inc.’s (OTCC BB: CEMI)
rapid test for the detection of TB in multiple animal species has been
recommended to the USDA for conditional approval and use for a period of
two
years by the United States Animal Health Association (USAHA). The announcement
was made near the conclusion of the USAHA’s annual meeting held recently in
Hershey, PA.
The
rapid
test developed by Chembio, VetTB STAT-PAK™, will be submitted to the USDA for
use as an ancillary diagnostic, along with the standard skin test, in order
to
more quickly and accurately detect TB in cattle, white-tail deer, elk, red
deer,
and reindeer.
Chembio
filed a patent application on its unique technology earlier this year. This
antibody detection assay employs a cocktail of carefully selected recombinant
antigens. The test can utilize serum, plasma, whole blood, or other body
fluids,
and provides results within 20 minutes.
Zoonotic
(naturally communicable to humans from animals) TB occurs in almost all
developed and developing nations of the world. The incidence of disease in
both
animals and humans is increasing worldwide, producing a significant negative
economic impact on global agribusiness. In addition to lost productivity
the
impact includes the increased risk of transmission from species to species,
including to humans. One chronic contagious respiratory disease that affects
many animal species and is of particular concern to man is bovine or cattle
associated TB. Veterinary TB can spread within and across species through
aerosols and through the ingestion of contaminated meat.
In
its
recommendation the TB SAS also advocated use of the Chembio VetTB STAT-PAK™
rapid serological test in cattle in conjunction with current testing strategies
in program herds and also strongly encouraged producers in the cervid (deer,
reindeer, elk, etc.) industry to support the evaluation of Chembio’s VetTB
STAT-PAK™ by providing samples for analysis from all species of
Cervidae.
ABOUT
CHEMBIO
Chembio
Diagnostics Inc. (Chembio) is a global leader in the development, research,
manufacturing and marketing of rapid diagnostic tests for various infectious
diseases, including HIV, human and veterinary TB, and Chagas Disease. Chembio
Diagnostic Systems, Inc. is the 100%-owned subsidiary of Chembio Diagnostics,
Inc. Additional information can be found at www.chembio.com.
ABOUT
USAHA
The
United States Animal Health Association (www.usaha.org),
the
nation's animal health forum for over a century, is a science-based, non-profit,
voluntary organization. Its 1,400 members are state and federal animal health
officials, national allied organizations, regional representatives, and
individual members. USAHA works with state and federal governments,
universities, veterinarians, livestock producers, national livestock and
poultry
organizations, research scientists, the extension service and seven foreign
countries to control livestock diseases in the United States. USAHA represents
all 50 states, 7 foreign countries and 18 allied groups serving health,
technical and consumer markets.
FORWARD-LOOKING
STATEMENTS
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 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 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.
Media
contact: Judy
Katz / Janet Vasquez The Investor Relations Group,
212-825-3210.