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) September
12, 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.
On
September 12, 2006 the Registrant issued the press release titled “PEPFAR
Funding 396,000 More of Chembio’s HIV Tests for Nigeria” included herein as
Exhibit 99.1.
ITEM
9.01. Financial Statements and Exhibits
(d) Exhibits.
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99.1
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Press
Release titled “PEPFAR Funding 396,000 More of Chembio’s HIV Tests for
Nigeria” issued September 12, 2006.
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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:
September 12, 2006 Chembio
Diagnostics, Inc.
By: /s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1 Press Release of 9/12/06
PEPFAR
Funding 396,000 More of Chembio’s HIV Tests for Nigeria
N.Y.
-
September 12, 2006 - Chembio Diagnostics, Inc. (OTCBB:CEMI) has received
a new
order for 396,000 HIV 1/2 STAT-PAK(TM) rapid tests. The Company plans
to ship
these tests, which will be used for voluntary counseling and testing
programs in
Nigeria, in September and October, 2006. The United States President’s Emergency
Plan for Aids Relief (PEPFAR), a five year $15 billion global initiative
to
combat the HIV/AIDS epidemic, is funding the purchase order which was
placed by
the United States Centers for Disease Control. Chembio has received in
the last
five months orders for more than 700,000 tests funded by PEPFAR for Nigeria.
Chembio believes that this is continued evidence of the commitment by
Nigerian
public health officials, working with PEPFAR and other stakeholders,
to their
treatment targets, and their knowledge that rapid HIV tests play a crucial
role
in meeting these targets.
With
an
estimated 135 million residents, Nigeria is Africa’s most populous country.
Approximately 3.6 million Nigerians are believed to be HIV-infected.
Only a
small percentage are aware of their status, with only 28,500 currently
receiving
anti-retroviral (ARV) treatment, according to a recent report to Congress
by
PEPFAR. PEPFAR’s goal is for 350,000 Nigerians to receive anti-retroviral
treatment by 2008, which the Company believes will require rapid tests
several
times that figure in order to identify those eligible for treatment.
In addition
to the PEPFAR targets, the Nigerian National Action Committee on AIDS
(NACA) is
aiming to put 250,000 additional people on anti-retroviral viral treatment
as
soon as possible. Because rapid HIV tests allow patients to be screened,
confirmed at the point of care, and referred for treatment where appropriate,
the rapid tests are expected to help Nigeria meet its treatment
goals.
The
Nigerian Ministry of Health has designated Chembio’s HIV 1/2 STAT-PAK(TM) as a
screening test to be used in four out of the eight testing protocols
that
comprise Nigeria’s Interim National Testing Algorithm. Nigeria is initially
implementing a “parallel testing algorithm” that uses two screening tests from
different manufacturers on each patient tested.
ABOUT
CHEMBIO
Chembio
Diagnostics, 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(TM) rapid tests. The Company also
manufactures rapid tests for veterinary Tuberculosis and Chagas Disease,
and has
developed a patent-pending technology, the Dual Path Platform (DPP(TM)),
for its
next generation HIV and other rapid tests. 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:
The
Investor Relations Group 212-825-3210
Investors:
James Carbonara
Media:
Susan Morgenbesser