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 4, 2008 (January
29, 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 Disclosures.
On
January 29, 2008, the Company issued the press release titled “Chembio in
Additional Technology Pacts with Oswaldo Cruz Foundation” included herein as
Exhibit 99.1.
ITEM
9.01. Financial Statements and Exhibits
Exhibits.
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99.1
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Press
Release titled “Chembio
in Additional Technology Pacts with Oswaldo Cruz
Foundation”
issued January 29, 2008.
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In
accordance with General Instruction B.2 of Form 8-K, the information disclosed
in Item 7.01 of, and Exhibit 99.1 attached to, this Current Report on Form
8-K
shall not be deemed “filed” for the purpose of Section 18 of the Securities
Exchange Act of 1934, nor shall it be deemed incorporated by reference in any
filing. This Current Report on Form 8-K does not constitute a
determination of whether any information included herein is
material.
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
4,
2008 Chembio
Diagnostics, Inc.
By: /s/
Lawrence A.
Siebert
Lawrence
A. Siebert
Chief
Executive Officer
CHEMBIO
IN ADDITIONAL TECHNOLOGY PACTS WITH OSWALDO CRUZ
FOUNDATION
Company’s
DPP™ Technology Licensed for Screening Programs Funded by Brazil’s Ministry of
Health
MEDFORD,
N.Y. and RIO DE JANEIRO, BRAZIL (January 29, 2008) – Chembio Diagnostics, Inc.
(OTC BB: CEMI) (“Chembio” or the “Company”) and the Bio-Manguinhos unit
of the Oswaldo Cruz Foundation of Brazil today announced the
completion of three new technology transfer, supply and license agreements
for
products being developed by Chembio with its patented Dual Path Platform
(DPP™)
technology. Previously, in 2004, Bio-Manguinhos and Chembio entered
into a similar agreement concerning one of Chembio’s HIV rapid
tests.
Two
of
the products being developed by Chembio will be used in screening programs
funded by Brazil’s Ministry of Health for the control and eradication of
Leishmaniasis and Leptospirosis, respectively, which are both blood-borne
infectious diseases that are endemic in Brazil. A third test being
developed is for the confirmation of HIV-1 in patients who have tested positive
with a screening test. Bio-Manguinhos, also known as the Immunobiological
Technology Institute, is the largest producer of vaccines and kits for diagnosis
of infectious and parasitic diseases in Latin America.
Chembio’s
DPP™ test platform was selected for the screening programs because of its high
sensitivity and specificity of prototypes evaluated by Bio-Manguinhos and
because of the unique multiplexing capabilities of DPP™ for the confirmatory
assay. The DPP™ point-of-care screening tests will complement the current
Bio-Manguinhos national program, which currently only uses laboratory-based
technologies. The HIV confirmatory test will allow for the simultaneous binding
and uniform delivery of samples to multiple HIV antigens printed in the
detection zone, providing results equivalent to Western blot in a simple
point-of-care format that provides results within 20 minutes.
Under
the
new agreements, once the products meet mutually agreed-upon performance
specifications and are approved for sale in Brazil, Chembio will receive
a
minimum purchase order for at least one million tests within a one year period.
Thereafter, the agreement allows for production of the products to be
transferred to Brazil, subject to certain royalty payments. This is similar
to
Chembio’s 2004 agreement with Bio-Manguinhos for one of the Company’s rapid HIV
tests.
Dr.
Akira
Homma, founder and Director of Bio-Manguinhos commented: “The DPP™ is an
important evolution in Rapid Test technology and is going to be an important
technological platform for Bio-Manguinhos production of reagents for diagnosis
tests. No doubt, the creation of an instrument that provides results in a
few
minutes, in the field or laboratories, will be very valuable for Brazilian
Public Health. Chembio is an important partner in this area and we hope to
strengthen this partnership for developing new products that are necessary
for
Brazilian Public Health.” The full text of the Bio-Manguinhos press
release can be viewed at the following link:
http://www.fiocruz.br/bio/cgi/cgilua.exe/sys/start.htm?infoid=608&sid=227.
Javan
Esfandiari, Senior Vice President of Chembio, said, “We are very pleased to be
building on our relationship with Bio-Manguinhos and to be continuing to
demonstrate the value of DPP™ technology in screening for infectious diseases.
Our internal and external studies have demonstrated high sensitivity and
specificity for our DPP™ assays for Leishmania, Leptospirosis and HIV 1
confirmatory tests in comparison with conventional rapid lateral flow
technology.”
Lawrence
Siebert, Chembio’s Chairman and CEO, commented, “We are pleased to expand our
relationship with Bio-Manguinhos. This agreement also serves to
advance the scale up of our DPP™ production capability for future DPP™
collaborations.”
ABOUT
LEISHMANIA AND LEPTOSPIROSIS
Leishmanias
is transmitted by the bite of a tiny (2-3 millimeter) insect vector,
the phlebotomine sandfly. Visceral leishmaniasis – also known as
kala azar – is characterized by irregular bouts of fever, substantial weight
loss, swelling of the spleen and liver, and anemia (occasionally serious).
If
left untreated, the fatality rate in developing countries can be as high
as 100%
within two years. Over the past 10 years, endemic regions have been
spreading further and there has been a sharp increase in the number of recorded
cases of the disease. As declaration is compulsory in only 32 of the 88
countries affected by leishmaniasis, a substantial number of cases are never
recorded. In fact, 2 million new cases (1.5 million for CL and 500,000 for
VL)
are considered to occur annually, with an estimated 12 million people presently
infected worldwide. Brazil has also experienced a sharp increase in the number
of cases. Dogs habitually kept in the domestic environment are the principal
animal reservoir, and children under the age of 15 years are the most severely
affected age group. Current eradication programs in Brazil are
therefore focused on this vector canine population. As such,
currently-used, laboratory-based diagnostic technologies are impractical
for
determining whether dogs are infected.
Leptospirosis,
also known as Weil’s disease, is an emerging infectious disease caused by
spirochetes of the genus Leptospira that affects humans and a wide range
of
animals, including mammals, birds, amphibians and reptiles. It is
considered the most widespread zoonotic disease in the world. Human disease
is
acquired primarily through contact with water contaminated with the urine
of
infected wild or domestic animals. There are as many as 500,000 severe human
cases worldwide each year. With few laboratories equipped to perform
the antiquated microagglutination test upon which diagnosis now depends,
it is
well recognized that human leptospirosis is an under-recognized
disorder. Leptospirosis is recognized as an emerging infectious
disease in the U.S., where flooding and fresh water recreation has caused
extensive outbreaks of the disease. In less developed countries,
leptospirosis is a major public health problem causing substantial morbidity
and
mortality among subsistence farmers and urban slum dwellers.
Rapid
testing will allow early diagnosis of Leptospirosis infection (IgG and IgM
antibodies in blood) in acute phase in the field or community setting and
treatment can be initiated immediately when it is the most effective.
Furthermore, an accurate diagnostic test will help to rule out other infections
similar to leptospiroris such as dengue.
ABOUT
BIO-MANGUINHOS
Bio-Manguinhos,
also known as the Immunobiological Technology Institute, is the largest producer
of vaccines and kits for diagnosis of infectious and parasitic diseases in
Latin
America. With a physical infrastructure comprising nearly 600,000 square
feet
and a workforce of approximately 1,000, Bio-Manguinhos was created by Dr.
Akira
Homma, its current Director, in 1976. The unit is capable of
processing over 200 million doses of vaccines per year, supplying up to 100
million doses per year of yellow fever vaccine alone to meet Brazilian and
export requirements. In 2006, the unit was awarded the Prize for Best Public
Health Institution in the world granted by the World Federation of Public
Health. Up to 2.5 million kits are produced each year through
agreements with the Health Surveillance Secretariat and the National Program
on
Sexually Transmitted Diseases and Aids, both from the Ministry of Health.
In
2004, Bio-Manguinhos signed a technology transfer, supply and license agreement
with Chembio for one of Chembio’s rapid HIV tests.
ABOUT
CHEMBIO DIAGNOSTICS
Chembio
Diagnostics, Inc., a developer and manufacturer of proprietary rapid diagnostic
tests, participates in the growing $5 billion point-of-care testing market.
Chembio’s two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the
U.S. by Inverness Medical Innovations, Inc. 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, N.Y. 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 are estimates only, as the Company has
not completed the preparation of its financial statements for those periods,
nor
has its auditor completed the audit of those results. Actual revenue
may differ materially from those anticipated in this press
release. 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 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
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