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) February
22, 2006
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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of
Incorporation)
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Identification
Number)
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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.
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(a)
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On
February 22, 2006 the Registrant issued the press release titled
“Chembio
Appoints Distributor for its Rapid HIV Tests in Ethiopia” included herein
as Exhibit 99.1.
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(b)
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On
February 23, 2006 the Registrant issued the press release titled
“Chembio’s Rapid HIV Test Selected by Nigeria” included herein as Exhibit
99.2.
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(c)
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On
February 24, 2006 the Registrant issued the press release titled
“Chembio
to Present at the Wall Street Analysts Forum” included herein as Exhibit
99.3.
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ITEM
9.01. Financial Statements and Exhibits
(c) Exhibits.
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99.3
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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:
February 27, 2006
Chembio
Diagnostics, Inc.
By:
/s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1 Press Release of 2/22/06
Chembio
Appoints Distributor for its Rapid HIV Tests in Ethiopia
MEDFORD,
N.Y. - February 22, 2006 - Chembio Diagnostics, Inc. (OTCBB: CEMI) has appointed
Setema, Ltd. to distribute its rapid HIV tests in Ethiopia. Ethiopia has
a
population of over 73 million of which an estimated 1.5 million are infected
with HIV. Under the auspices of the President’s $15 billion Emergency Plan for
AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, TB and Malaria, the
United States recently signed an agreement to provide Ethiopia with over
$84
million to prevent and treat HIV/AIDS. This will include a significant scale-up
of rapid testing programs. Chembio believes these programs are crucial in
Ethiopia and other countries ravaged by the AIDS epidemic. Rapid tests
effectively identify patients that may require anti-retroviral treatment.
Ethiopia is currently evaluating rapid HIV tests including Chembio’s two HIV 1/2
STAT-PAK(TM) tests for possible inclusion in Ethiopia’s testing protocol.
Setema
is
one of the largest medical device distributors in Ethiopia and the country’s
sole supplier of HIV viral load tests. Viral load tests monitor patients
already
identified with HIV (e.g., with a rapid test) to determine if and when they
require anti-retroviral therapy.
Ethiopia
is one of 50 countries worldwide that is part of the Clinton HIV/AIDS Initiative
Procurement Consortium. Chembio was recently selected by the Clinton HIV/AIDS
Initiative (“CHAI”) as one of four global suppliers of rapid HIV tests to these
countries pursuant to the Memoranda of Understanding (MOU) CHAI has with
them.
For further information please visit www.clintonfoundation.org.
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.
For additional information please visit www.chembio.com.
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 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.
Contact:
Vince
Daniels/James Carbonara
The
Investor Relations Group 212-825-3210
Exhibit
99.2 Press Release of 2/23/06
Chembio’s
Rapid HIV Test Selected by Nigeria
Projected
Need for 35 Million Tests to Attain PEPFAR 2008 Goal
MEDFORD,
N.Y. - February 23, 2006 - The Nigerian Ministry of Health announced this
week
that Chembio Diagnostics, Inc.’s (OTCBB:CEMI) HIV 1/2 STAT-PAK(TM) is designated
as a screening test in four out of the eight testing protocols that comprise
Nigeria’s Interim National Testing Algorithm. Nigeria is initially implementing
a “parallel testing algorithm”, and as such uses two screening tests from
different manufacturers on each patient tested. This program is being launched
very soon to quickly and accurately identify HIV positive individuals so
that
treatment goals can be achieved.
Nigeria
is Africa’s most populous country with an estimated 135 million inhabitants. It
has an estimated 3.6 million HIV infected individuals of which only 28,500
are
currently receiving anti-retroviral (ARV) treatment according to a recent
report
to Congress by PEPFAR, the acronym for President Bush’s $15 billion Emergency
Plan for AIDS Relief. PEPFAR’s goal is for 350,000 Nigerians to receive
anti-retroviral treatment by 2008. Rapid HIV tests allow patients to be screened
and confirmed at the point of care, and will help in Nigeria’s efforts to scale
up testing and thereby meet its treatment goals more rapidly. In addition
to the
PEPFAR targets, the Nigerian National AIDS Control Administration (NACA)
is
aiming to put 250,000 people on anti-retroviral viral treatment as soon as
possible. Chembio believes, based upon estimates by the Global Business
Coalition on HIV/AIDS (www.businessfightsaids.org) and other experts that
on
average approximately 100 people need to be tested in order to identify one
person eligible for treatment. This results in a projected need for 35 million
patients to be tested (with at least one screening test) just to meet the
goals
established by PEPFAR for Nigeria.
““We
are
very pleased to be selected for Nigeria’s Interim National Testing Algorithm. I
believe that millions of individuals will need to be tested in order to identify
HIV patients suitable for ARV treatment and to meet treatment targets,” said Avi
Pelossof, Chembio’s Vice President of Sales, Marketing and Business Development.
Chembio
is committed to supporting Nigeria’s treatment goals with its rapid HIV tests.
In late 2005, Chembio established Chembio Diagnostics Nigeria Ltd., a wholly
owned subsidiary headed by Dr. Joseph Nnorom, MD, MPH. Dr. Nnorom was until
most
recently the Medical Epidemiologist of the U.S. CDC's Global AIDS Program
in
Nigeria, and has been working on HIV/AIDS in Nigeria for more than 20 years.
“We
are
proud to be associated with Nigeria’s focused efforts to strengthen its response
to the HIV/AIDS epidemic. Improved counseling and testing services will help
Nigerians determine their serostatus and do something about it. Counseling
and
testing is as important to HIV prevention as it is to care and treatment",
said
Dr. Nnorom.
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. For additional information please visit
www.chembio.com.
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 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.
Contact:
Vince
Daniels/James Carbonara
The
Investor Relations Group 212-825-3210
Exhibit
99.3 Press Release of 2/24/06
Chembio
to Present at the Wall Street Analysts Forum
MEDFORD,
N.Y. - February 24, 2006 - Chembio Diagnostics Inc.’s (OTCBB: CEMI) Chairman and
President, Lawrence Siebert, will present at the 17th
annual
Wall Street Analysts Forum on Tuesday, February 28th at 10:20 AM (EST) at
the
Princeton Club of New York in midtown Manhattan. A live webcast of the
presentation will be available on the Company’s website at www.chembio.com.
Additional information regarding the conference can be found at
www.Analyst-conference.com.
Mr.
Siebert will speak about the Company’s development of their rapid diagnostic
tests for infectious diseases. He will address the effect that government
funding, treatment goals and HIV/AIDS initiatives are having towards the
worldwide demand for rapid HIV diagnostic tests, as well as the status of
their
PMA application to the United States Food & Drug Administration for U.S.
marketing approval. Chembio's rapid HIV tests include the HIV 1/2 STAT-PAK(TM),
HIV 1/2 STAT-PAK Dipstick and the HIV 1/2 SURE CHECK(R). These tests are
simple,
safe and cost-effective requiring less than five microliters of blood from
a
fingerstick sample.
ABOUT
CHEMBIO
Chembio
Diagnostics, Inc. (OTCBB: CEMI) possesses
expertise in the development and manufacturing of rapid diagnostic tests
for
various infectious diseases. Chembio
is participating in the frontlines of the global battle against the devastating
AIDS pandemic. This battle, to which the United States alone has pledged
$15
billion in international aid, is the impetus behind Chembio’s rapid HIV tests.
Because rapid tests can detect HIV antibodies within minutes, the massive
prevention and treatment programs that are now scaling up can be much more
effective. Chembio is one of four global rapid HIV test suppliers under the
Clinton HIV/AIDS Initiative (www.clintonfoundation.org). The Company also
manufactures additional rapid tests that it has developed for other deadly
diseases, including human and veterinary 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. For additional information please
visit www.chembio.com.
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 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.
Contact:
Vince
Daniels/James Carbonara
The
Investor Relations Group 212-825-3210