MEDFORD, NY--(Marketwire - June 25, 2009) - Chembio Diagnostic Systems, Inc. (a
wholly-owned subsidiary of Chembio Diagnostics, Inc.) (OTCBB: CEMI) has
been awarded a three-year $3 million Small Business Innovative Research
(SBIR) Phase II grant from the United States National Institutes of Health
(NIH) to fully develop, validate, and commercialize a rapid diagnostic test
for leptospirosis for general use worldwide. The test will be developed
utilizing Chembio's patented Dual Path Platform (DPP®) technology
together with proprietary reagents developed by Cornell University and the
Oswaldo Cruz Foundation at the Brazilian Ministry of Health.
Development of the test will be in collaboration with the Division of
Infectious Diseases, Weill Medical College, Cornell University in New York
and the Oswaldo Cruz Foundation, the largest biomedical research
institution in Latin America. In the Phase I work completed in 2008, which
occurred with this same collaborative group, novel diagnostic targets were
identified and evaluated in a prototype test in Chembio's patented DPP®
format. The studies demonstrated that the test prototype had an overall
sensitivity of 85% and a specificity of 90% using serum samples of
leptospirosis patients from Brazil and Thailand. Furthermore, the DPP®
prototype had a sensitivity of 78% in identifying leptospirosis in the
first 7 days of illness, the "window-of-opportunity" during which
initiation of antimicrobial therapy provides the greatest benefit.
The lack of an effective diagnostic test has been one of the major barriers
to addressing leptospirosis, a life-threatening zoonotic disease, whose
global burden is estimated to be as high as 500,000 cases annually.
Leptospirosis is an emerging infectious disease problem in industrialized
countries such as the US, and is a significant cause of mortality and
morbidity among impoverished populations in developing countries.
Leptospirosis, especially in the early stage of illness, is often
misdiagnosed as dengue, malaria and other causes of acute fever. The delay
in detecting leptospirosis has potentially severe consequences since the
disease progresses to cause life-threatening manifestations such as
pulmonary hemorrhage syndrome and acute renal failure.
Dr. Albert Ko, Associate Professor of Medicine at Weill Medical College,
Cornell University and Visiting Researcher at Oswaldo Cruz Foundation,
commented, "The collaboration with Chembio has been successful in applying
the selected markers to Chembio's DPP format. This grant enables us to
complete development of the assay and make it available to health
professionals and public health authorities as part of an effort in
combating this important global infectious disease problem."
Javan Esfandiari, Senior Vice President of R&D of Chembio, commented, "We
are pleased with the recognition that the awarding of this grant by NIH
provides Chembio and to our patented DPP® technology. I am most
appreciative of the excellent work of Dr. Albert Ko from Cornell and Dr.
Konstantin Lyashchenko, Chembio's Senior R&D Director, as well as the rest
of Chembio's R&D team."
About DPP®
The Dual Path Platform immunoassay is a recent innovation in the field of
rapid testing for which Chembio received a US patent in 2007. DPP®
technology employs two separate and distinct membrane strips, one for the
sample migration and one for the test reagents. This unique dual-flow
design allows for improved control and management of the sample flow. As a
result, the immunological reaction is more efficient than lateral flow
tests based upon studies performed by Chembio.
About Weill Cornell Medical College
The Division of Infectious Diseases at Weill Medical College mission
encompasses clinical care, research, and education. The Division has 50
full-time and voluntary faculty members and is responsible for the New
York-Presbyterian Hospital/Weill Cornell Medical Center's Infectious
Diseases Clinical Service, the HIV/AIDS Program and the Weill Cornell
Travel Medicine Clinic (WCTMC). The Weill Cornell HIV/AIDS Program provides
care to ~2,000 HIV-infected persons, in addition to conducting basic and
clinical research. The WCTMC is staffed by the faculty and provides travel
advice and immunizations for ~3,000 persons annually, in addition to
infectious diseases consultations. The Infectious Diseases Fellowship
Training Program provides individualized training through faculty guidance,
clinical rotations, mentored research, and didactic coursework. The
Division has a cadre of internationally recognized physician-scientists who
are devoted to basic laboratory and patient-centered research, education
and service, both in the United States and abroad (Brazil, Haiti, India,
Nigeria, Tanzania, and Tunisia).
About Oswaldo Cruz Foundation
Bio-Manguinhos/ Oswaldo Cruz ("FIOCRUZ") is the largest immuno-biological
producer (vaccines, kits for diagnosis of infectious and parasitic
diseases, and bio-pharmaceuticals, such as erytropoetin and interferon) in
Latin America. With a physical infrastructure comprising nearly 600,000
square feet and a workforce of approximately 1,000, Bio-Manguinhos was
created in 1976. The unit is capable of processing over 120 million doses
of vaccines per year, supplying up to 30 million doses per year of yellow
fever vaccine alone to meet Brazilian and export requirements. In 2006,
FIOCRUZ 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 entered
into a technology transfer, supply and license agreement with Chembio for
one of Chembio's rapid HIV tests, and in January 2008, entered into similar
agreements for DPP® rapid tests for Leishmania and Leptospirosis, and a
third agreement for a multiplex DPP® test for the confirmation of HIV-1
that could be performed at the point of care.
About Chembio Diagnostics
Chembio Diagnostics, Inc., through its wholly-owned subsidiary Chembio
Diagnostic Systems, Inc., develops, manufactures, licenses and markets
proprietary rapid diagnostic tests 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 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 are estimates only, as the Company has not
completed the preparation of its financial statements for those periods,
nor has its auditor completed a review or 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.
