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
3, 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)
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Identification
Number)
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|||
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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
2.02. Results of Operations and Financial Condition.
| (a) |
On
October 3, 2005, the Registrant issued the press release titled “Chembio
Quarter Net Sales Up By 93% Over 2004” 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 3, 2005 Chembio
Diagnostics, Inc.
By:
/s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
PRESS
RELEASE
Chembio
Third Quarter Net Sales Up By 93% Over 2004
MEDFORD,
N.Y.--(Market Wire)—Oct. 3, 2005: Chembio Diagnostics, Inc. (CEMI: OTCBB)
announced today that third quarter shipments of 220,000 HIV 1/2 Stat Pak™ test
kits to Bio-Manguinhos, an affiliate of the Brazilian Ministry of Health
(MOH),
one of the largest manufacturers of vaccines in the world and a growing
diagnostic producer, when taken together with other third quarter sales,
by
company estimates will increase net sales for the three-month period ended
Sept.
30, 2005 to an estimated $850,000, a 93% increase over net sales of $440,371
for
the same period in 2004. 150,000 units were shipped during the second quarter.
Chembio
and Bio-Manguinhos have a three year technology transfer agreement to supply
HIV
tests to combat Brazil’s burgeoning AIDS problem. This agreement dictates that
over a three-year period starting 2004, Chembio will transfer its proprietary
technology to Bio-Manguinhos in exchange for test kit purchase commitments
during this transfer period. Chembio will receive royalties for ten years
once
Bio-Manguinhos starts production of these rapid tests using Chembio’s
proprietary technology. More news on this collaboration can be accessed at
www.chembio.com/images/Chembio_AIDSLink_Brazil.pdf
Chembio’s
rapid HIV tests include the HIV 1/2 Stat-Pak™, HIV 1/2 Stat-Pak™ Dipstick and
the Sure Check HIV™. All three tests are simple, safe, cost-effective and
operator-friendly requiring less than five micro-liters of blood from a
finger-stick. The HIV 1/2 Stat-Pak and the Sure Check HIV™ tests are currently
under review by the FDA for U.S. marketing.
Chembio
also reported today that it had received a court memorandum and order dated
September 27, 2005 responding to motions for claim construction and for summary
judgment in the case it brought in 2004 against Saliva Diagnostic Systems,
Inc.
(“SDS”) in the U.S. District Court Eastern District of New York. Chembio is
seeking a declaratory judgment that Chembio’s Sure Check™ HIV barrel device does
not infringe SDS’ US Patent #5,935,864, or in the alternative, that the ‘864
patent is invalid or unenforceable. The motions for summary judgment made
by
both parties were denied, opening the way to fact discovery in the case.
In
responding to the motion for claim construction, the order interpreted the
patent in a way such that only the sampling part of the device is to exclude
absorbent material, a narrower finding than what Chembio’s motion had requested.
The case is in a preliminary stage and this order does not address issues
of
patent infringement, validity or enforceability.
Chembio
is seeking FDA approval for its Sure Check™ HIV as well as its HIV 1/2 Stat Pak
™ product, making it the only company that would have multiple rapid test
formats in the US market. Although Sure Check™ HIV’s higher cost and limited
flexibility as to sample type compared with the Stat Pak ™ formats make Sure
Check™ HIV less desirable in donor-funded developing country programs, it may be
a desirable format in certain user and market segments in the US and other
developed countries that have greater financial resources .
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.