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) November
7, 2005
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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||
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of
Incorporation)
|
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
November 7, 2005 the Registrant issued the press release titled
“Chembio
Diagnostics, Inc. Reports 2005 Third Quarter Results” included herein as
Exhibit 99.1.
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ITEM
7.01. Regulation FD Disclosures.
| (a) |
On
November 7, 2005 Chembio Presented a PowerPoint slide show at the
Rodman
& Renshaw Techvest included herein as Exhibit
99.2.
|
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:
November 7, 2005 Chembio
Diagnostics, Inc.
By:
/s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1 Press Release
Chembio
Diagnostics, Inc. Reports 2005 Third Quarter Results
MEDFORD,
N.Y.--(MARKET WIRE)--November 7, 2005--Chembio Diagnostics, Inc. (OTCBB:CEMI
-
News) announced today its results for the third quarter ended September 30,
2005.
The
Company’s net loss for the third quarter was $831,982 versus a net loss of
$1,058,429 in the comparable 2004 period. The Company’s net loss for the nine
months ended September 30, 2005 was $2,328,634 versus a net loss of $2,205,618
in the comparable 2004 period. All results are before dividends on preferred
shares.
Third
quarter 2005 revenues were $944,712, a 67% increase compared to $566,246
for the
same period in 2004. Revenues for the nine months ended September 30, 2005
were
$2,582,287, a 20% increase compared to $ 2,146,623 for the same period in
2004.
The increases in both 2005 periods were attributable to increased sales of
the
Company’s HIV products.
The
Company experienced improved gross margins in the 2005 periods compared to
the
same periods in 2004, primarily as a result of the increased sales for our
HIV
products which were at higher margins than certain other products; in addition
the low sales volumes in the 2004 periods were not enough to cover fixed
overhead expenses.
"During
the third quarter the Company made significant progress toward its long term
goal of significant revenue growth and profitability and the Company's
management team remains highly focused on reaching those milestones," commented
Lawrence A. Siebert, Chembio's Chief Executive Officer.
The
Company’s FDA approval process for its Sure Check TM
HIV and HIV 1/2 Stat-Pak TM
is continuing. The FDA inspection of our facility that is required
in connection with the approval process was conducted in the third quarter
of
2005. “We believe we will complete all documentation requested by the FDA in
order to have an “approvable” Pre-Marketing Approval (PMA) application for these
two HIV products during the first quarter of 2006 and we expect to complete
the
full process during the first half of 2006,” said Mr. Siebert.
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.
Exhibit
99.2 Chembio Presentation