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
21, 2005
CHEMBIO
DIAGNOSTICS, INC.
(Exact
name of registrant as specified in its charter)
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Nevada
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333-85787
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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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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
Sept, 2005, the Registrant issued the press release titled “Chembio’s Hiv
1/2 Test Now The Confirmatory Test In Uganda” included herein as Exhibit
99.1.
|
ITEM
9.01. Financial Statements and Exhibits
(c) Exhibits.
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 21, 2005 Chembio
Diagnostics, Inc.
By:
/s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
CHEMBIO’s
HIV 1/2 TEST NOW THE CONFIRMATORY TEST IN UGANDA
MEDFORD,
N.Y.--(MarketWire)—Sept. 21, 2005 Chembio Diagnostics Inc., announced today that
Uganda’s Ministry of Health has officially designated Chembio’s rapid HIV 1/2
Stat Pak test to be the confirmatory test in its national testing algorithm.
The
national testing algorithm is the sequential protocol of tests typically
recommended by the ministries of public health to diagnose HIV/AIDS infected
persons, in conjunction with the VCT (Voluntary Counseling and Testing) and
PMTCT (Prevention of Mother to Child Transmission) programs. Once a patient
has
tested positive, the protocol in Uganda requires a second confirmatory rapid
test to follow the initial screening test at the point of care, since many
patients would otherwise fail to return for their confirmatory lab results.
The
market for rapid tests is expected to increase exponentially in Uganda as public
health officials are encouraging the use of rapid testing devices to diagnose
HIV/AIDS infected individuals. Uganda is one of the largest recipients of PEPFAR
(President’s Emergency Program for AIDS Relief) in Africa. While the screening
test is used on 100% of the people tested, the confirmatory test is used only
on
those who test positive, a number which varies with the prevalence of the
disease in the groups screened. Uganda’s demand for rapid HIV tests exceeded
400,000 in 2004, with the number expected to exceed 1.5 - 2.0 million tests
for
2005.
Chembio
also announced that Quality Chemicals Limited (QCL) will be its distributor
in
Uganda. QCL, a leading importer and distributor in the sales of medical devices
and drugs, is the largest supplier of antiretroviral drugs (ARVs) to the Ugandan
government. Incorporated in 1997 as a result of the Ugandan government’s
liberalization and privatization policies, QCL has played a significant role
in
helping this HIV ravaged region acquire much-needed testing devices and drugs.
QCL recent agreement with Cipla of India to build an ARV facility in Kampala
will be the first of its kind, allowing Uganda to scale up the manufacture
of
ARVs to treat infected individuals.
“We
are
very pleased to be Chembio’s partner, in light of the StatPak test now being the
confirmatory test in Uganda” said Emmanuel Katangole, Managing Director of QCL.
“Testing being the gateway to treatment, this collaboration fits in very well
with QCL’s mission to help Uganda control the HIV pandemic.”
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. Chembio's Investor Relations contact is Maya Wagle
at
631-924-1135/ ext.125. Email can be directed to mwagle@chembio.com.
Additional information can be found at 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 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.