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
1, 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
|
(Commission
File Number)
|
(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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||||
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Medford,
NY 11763
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||||
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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.
| 99.1 |
On
December 1, 2005 the Registrant issued the press release titled “On World
Aids Day Chembio Updates Its Progress In Serving Global Need For
Rapid HIV
Testing” included herein as Exhibit 99.1.
|
ITEM
9.01. Financial Statements and Exhibits
(c) Exhibits.
| 99.2 |
.
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 1, 2005 Chembio
Diagnostics, Inc.
By:
/s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1 - Press Release
PRESS
RELEASE
ON
WORLD AIDS DAY CHEMBIO UPDATES ITS PROGRESS
IN
SERVING GLOBAL NEED FOR RAPID HIV TESTING
MEDFORD,
N.Y.--(Market Wire)--December
1, 2005--With
today marking the 18th
annual
World AIDS Day, Chembio Diagnostics, Inc. (OTCBB: CEMI)
is
updating its investors on its role in the growing global demand for affordable
rapid HIV tests.
A
member
of the Global Business Coalition (“GBC”) on HIV/AIDS (www.businessfightaids.org
),
Chembio supports the position taken by GBC’s Chairman, Richard Holbrooke, in
yesterday’s Washington Post regarding the need for a more aggressive scale-up in
rapid testing for HIV/AIDS.
Chembio
will participate in today’s World AIDS Day 2005 Commemoration, hosted by UNAIDS,
in partnership with the African Services Committee and the New York City
Department of Health.
Furthering
its efforts to engage local stakeholders in the geographic locations where
these
tests are most urgently needed, Chembio will likewise participate in the
14th
International Conference on AIDS and sexually transmitted diseases (ICASA)
in
Africa scheduled for next week in Abuja, Nigeria.
US
APPROVAL
Clinical
data for two of Chembio’s three rapid HIV tests, HIV 1/2 STAT-PAK™ and SURE
CHECK® HIV 1/2 are in final review by the United States Food and Drug
Administration (“FDA”). The FDA has already completed the inspection of
Chembio’s facility. Chembio is in discussions with potential US marketing
partners.
INTERNATIONAL
APPROVALS
Chembio’s
rapid HIV tests, qualified by the World Health Organization (“WHO”), are already
approved for purchase internationally. These tests have also been approved
for
international procurement by the United States Agency for International
Development (USAID) and the United States Centers for Disease Control. These
are
the agencies responsible for implementing President Bush’s five-year, $15
Billion Emergency Plan for AIDS Relief (PEPFAR) program.
Chembio
is the only rapid HIV test manufacturer approved by these government agencies
that offers three rapid HIV test formats, and the only US-based company with
products priced to meet the massive need for these tests worldwide.
Chembio
also has new patent-pending rapid HIV test technologies in development.
LATIN
AMERICA
As
previously reported, Chembio expects that 2005 orders will total 700,000
units,
an increase from 450,000 units in 2004, from its Brazilian customer, The
Oswaldo
Cruz Institute, affiliated with the Brazilian Ministry of Health.
Chembio’s
SURE CHECK® HIV 1/2 is also approved for sale in Mexico. The Company is actively
pursuing sales opportunities in Mexico as well as in several other markets
in
South America.
AFRICA
Over
the
last six months, Chembio has established regional offices in East and West
Africa. The Company is now finalizing agreements with distributors in Uganda,
Kenya, Mozambique, Ethiopia, Tanzania and Zambia. In Uganda, a world-wide
leader
in prevention and treatment efforts, Chembio’s HIV 1/2 STAT-PAK™ test is in the
national testing protocol. One or more of Chembio’s three rapid HIV tests are
also under evaluation for inclusion in the national protocols of other African
nations. Local assembly is being considered.
OTHER
MARKETS
Chembio
is seeking to extend its global reach in other markets through local,
governmental and non-governmental partnerships that recognize the urgent
need
for rapid HIV testing.
ABOUT
CHEMBIO
Chembio
Diagnostics, Inc. (Chembio) possesses expertise in the development and
manufacturing of rapid test products for various infectious diseases, including
HIV, Tuberculosis and Chagas Disease. References to Chembio Diagnostics,
Inc.
may actually refer to Chembio Diagnostic Systems, Inc.; the 100%-owned
subsidiary of Chembio Diagnostics, Inc. Chembio is located at 3661 Horseblock
Road, Medford, NY 11763.
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.