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) October
20, 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
October 20, 2005, the Registrant issued the press release titled
“Chembio
Welcomes FDA’s Consideration of OTC AIDS Tests” 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:
October 20, 2005 Chembio
Diagnostics, Inc.
By:
/s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1 Press Release of 10/20/2005
CHEMBIO
WELCOMES FDA’s CONSIDERATION OF OTC AIDS TESTS
MEDFORD,
N.Y.--(Market Wire)—Oct. 20, 2005: Chembio Diagnostics, Inc. (CEMI: OTCBB) today
welcomed news that the FDA Blood Products Advisory Committee (BPAC) will
be
considering whether and under what conditions it could allow rapid HIV tests
to
be sold over-the-counter (OTC) to consumers for at home testing. This
consideration by BPAC was recently announced by OraSure Technologies, Inc.
(OSUR) and reported in the New York Times. OraSure and Chembio are among
a small
group of companies in the US that have or are seeking FDA approval of rapid
HIV
tests for use in the professional market such as public health clinics and
emergency rooms. These tests incorporate technologies that allow the tests
to be
performed quickly, accurately, and with a minimal number of procedural steps.
Chembio
is seeking professional use FDA approval for its Sure Check™ and HIV Stat-Pak™
products. Chembio’s management believes that its tests could be well suited for
the OTC market if that market becomes available. However, there is no assurance
that the FDA will decide to allow OTC marketing of rapid HIV tests. Furthermore,
the specific conditions relating to any such allowance can not be known at
this
time.
“We
are
immensely pleased that the FDA is considering a process which would make
AIDS
testing as easy as diabetes and pregnancy testing,” said Larry Siebert, Chairman
and CEO of Chembio. “Wider access to testing could help identify more positive
cases and improve prevention efforts.”
Chembio’s
rapid HIV tests include the HIV 1/2 Stat-Pak™, HIV 1/2 Stat-Pak Dipstick™ and
the HIV 1/2 Sure Check ™. These tests are simple, safe, cost-effective and
operator-friendly requiring less than five microliters of whole blood from
a
fingerstick.
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.