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): February 1, 2008 (February
27, 2008)
CHEMBIO
DIAGNOSTICS, 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 DISCLOSURE.
(a) On
February 1, 2008, Chembio Diagnostics, Inc. (the “Company”) entered into a
sublicense agreement (the “Agreement”) with Bio-Rad Laboratories, Inc. and
Bio-Rad Pasteur (collectively, “Bio-Rad”). Bio-Rad is the exclusive
licensee of Institute Pasteur of Paris, France, under the HIV-2
patents. Pursuant to the terms of the Agreement, Bio-Rad sublicensed
to the Company patents related to the use of HIV2. In exchange for
the use of the patents, the Agreement provides that the Company will pay
Bio-Rad
a $1,000,000 sublicense fee. The Company will also pay Bio-Rad a
royalty on net sales in the United States and Canada of rapid test immunoassay
tests sold under the Company’s name (a) for simultaneously detecting “HIV type 1
+ HIV type 2” antibodies and/or antigens; (b) being operated with the Company’s
Point of Care Rapid Test Platform; and (c) allowing visual and automated
signal
reading and interpretation through a single test unit format. The
Company will be manufacturing products under the sublicense agreement
immediately, but it does not currently have any sales that are subject to
the
royalty.
The
Agreement will continue until the expiration of the last-to-expire of the
sublicensed patents, unless otherwise terminated at an earlier date by the
Company or Bio-Rad. In connection with the Agreement and upon payment
of $275,000, Bio-Rad also will waive and release the Company from any claims
of
patent infringement under the sublicensed patents, and waive any right or
claim
to further royalties arising out of the manufacture, use, import, offer for
sale
or sale by the Company of the sublicensed products prior to the signature
date
of the Agreement.
(b) On
February 26, 2008, Chembio Diagnostics, Inc. (the “Company”) issued a press
release entitled “Chembio Acquires Non-Exclusive HIV-2 Patent Rights from
Bio-Rad.” A copy of the press release is furnished herewith as
Exhibit 99.1.
(c) All
of the information in this Item 7.01 of this Form 8-K is being furnished
and shall not be deemed “filed” for the purposes of Section 18 of the
Securities Exchange Act of 1934, or otherwise subject to the liabilities
of that
section. The information in this Item 7.01 of this Form 8-K also shall not
be deemed to be incorporated by reference into any filing under the Securities
Act of 1933, as amended, or the Securities Exchange Act of 1934, except to
the
extent that the Company specifically incorporates it by reference.
ITEM
9.01. FINANCIAL STATEMENTS AND EXHIBITS
Exhibit 99.1
– Press Release dated February 26, 2008.
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: February
27,
2008 CHEMBIO
DIAGNOSTICS, INC.
By: /s/
Lawrence A. Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1 Press Release
Chembio
Acquires Non-Exclusive HIV-2 Patent
Rights
from Bio-Rad
Sublicense
to Manufacture and Market Rapid Tests Detecting HIV-2 Under Chembio
Brands
MEDFORD,
NY – February 26, 2008 - Chembio Diagnostics, Inc. (OTCCBB:CEMI) announced today
that it has acquired a worldwide, non-exclusive sublicense from Bio-Rad
Laboratories, Inc. (AMEX: BIO and BIOb), for patents relating to the Human
Immunodeficiency Virus, Type 2, or HIV-2. Bio-Rad is the exclusive licensee
of
Institute Pasteur of Paris, France, under the HIV-2 patents.
“Securing
this HIV-2 sublicense strengthens our competitive position for the manufacture
and marketing of our current rapid HIV test and for our new Dual Path Platform
HIV 1/2 oral fluid test that is in development” said Larry Siebert, Chembio’s
President and CEO.”
“Bio-Rad
continues to work with global partners to expand the range of available HIV
diagnostic products,” said Norman Schwartz, Bio-Rad President and Chief
Executive Officer. “Granting a sublicense to Chembio for HIV-2 patents offers a
new diagnostics option to the public health community.”
Under
the
terms of the sublicense, Chembio has obtained non-exclusive rights to certain
HIV-2 patents from Bio-Rad, which will permit Chembio to manufacture and market
a rapid test for both HIV-1 and HIV-2 on a worldwide basis under Chembio brands.
Bio-Rad maintains rights to patents claiming the HIV-2 virus and various means
to detect its presence in infected patients. Other companies have also received
HIV-2 diagnostic sublicenses from Bio-Rad. Chembio is concurrently
filing with the SEC a Form 8-K that includes additional information concerning
the sublicense.
Chembio
currently has two FDA approved and CLIA waived rapid HIV tests that are being
marketed in the United States and globally. These tests are approved for
detecting antibodies to HIV-1 and HIV-2 in finger-stick whole blood, venous
whole blood, serum and plasma samples. There are an estimated 33 million people
in the world currently living with the HIV virus. Although the number of
reported cases of HIV-2 infection in the United States is still relatively
low,
the incidence of HIV-2 infection is significantly higher in certain other
countries, and many foreign countries now require testing for both HIV-1 and
HIV-2.
About
Chembio Diagnostics
Chembio
Diagnostics, Inc., a developer and manufacturer of proprietary rapid diagnostic
tests, participates in the growing $5 billion point-of-care (POC) testing
market. Chembio’s two FDA PMA-approved, CLIA-waived, rapid HIV tests are
marketed in the U.S. by a third party company. Chembio markets its HIV STAT-PAK®
line of rapid HIV tests internationally to government and donor-funded programs
directly and through distributors. Chembio also has rapid tests for veterinary
tuberculosis and chagas disease. In 2007, Chembio received a U.S. patent
for its Dual Path Platform (DPP™) technology which has significant advantages
over currently available lateral-flow technologies. This technology
is providing Chembio with a significant pipeline of business opportunities
for
the development and manufacture of new products based on DPP™. Headquartered in
Medford, NY with approximately 100 employees, Chembio is licensed by the U.S.
Food and Drug Administration (FDA) as well as the U. S. Department of
Agriculture (USDA), and is certified for the global market under the
International Standards Organization (ISO) directive 13.485.
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, to obtain regulatory approvals
for its products 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.
Contacts:
Company
Contact: Investor
Relations Contacts:
Chembio
Diagnostics,
Inc.
Lippert/Heilshorn & Associates, Inc.
Matty
Arce Anne Marie Fields
(afields@lhai.com)
(631)
924-1135, ext.
123 (212)
838-3777
www.chembio.com Bruce Voss
(bvoss@lhai.com)
(310)
691-7100