SOURCE: Chembio Diagnostics, Inc.

September 20, 2007 10:23 ET

Chembio Diagnostics Receives NIH Grant to Develop Rapid Point-of-Care Test for Leptospirosis

Timely Diagnosis Is Critical for Successful Treatment of Emerging Infectious Disease

MEDFORD, NY--(Marketwire - September 20, 2007) - Chembio Diagnostics, Inc. (OTCBB: CEMI) has been awarded a Small Business Innovative Research Phase I grant in the amount of ($286,000) from the National Institutes of Health (NIH) for the research and development of a rapid seriodiagnostic test for leptospirosis, which is recognized as an emerging infectious disease in the United States. Development of the test will be in collaboration with Weill Medical College of Cornell University in New York and the Oswaldo Cruz Foundation in Brazil, the largest research institution in Latin America.

The goal of this project is to develop a rapid point-of-care test for human leptospirosis based upon Chembio's innovative proprietary lateral flow technology (Dual Path Platform™ or "DPP™"). The collaborators have developed unique leptospiral antigens that will be used in the proposed work. Using a novel antigen screening method developed by Chembio (termed MAPIA), the most seroreactive antigens recognized during the acute phase of leptospirosis will be identified and a combination of the selected antigens will be used to develop a diagnostic DPP test prototype. The Phase I studies will determine the feasibility of proceeding into Phase II evaluations that could, upon application, also be funded by the NIH.

According to Javan Esfandiari, senior vice president of R&D Chembio Diagnostics, "We are especially pleased to be working on this collaboration with some of the world's leading researchers involved with this disease, including Dr. Albert Ko of Weil Medical College of Cornell University who is a visiting researcher at the Oswaldo Cruz Foundation in Brazil. Our DPP point of care/point of need tests are highly suitable for use in developing countries, as well as in a variety of field or community settings, because they require no equipment, are stable at room temperature and have long shelf lives."

Currently there is no effective prevention for leptospirosis, which can be treated with inexpensive antimicrobial agents. Timely treatment, however, is essential to prevent disease progression to renal or hepatic failure, and/or massive pulmonary hemorrhage. The major obstacle to successful treatment is the difficulty in making an early and accurate diagnosis. This NIH-funded project aims to develop a rapid point-of-care test that would enable antibiotic therapy to be initiated during the acute phase of the infection, when drug therapy is most effective.

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; 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. There are as many as 500,000 severe human cases worldwide each year.

Human disease is acquired primarily through contact with water contaminated with the urine of infected wild or domestic animals. 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.

About Chembio Diagnostics

Chembio Diagnostics, Inc., a developer and manufacturer of rapid diagnostic tests for infectious diseases, is on the frontlines of the global battle against the AIDS pandemic. The Company has received marketing approval from the FDA for its SURE CHECK® HIV 1/2 and HIV 1/2 STAT-PAK™ rapid tests, marketed under the brand name Clearview® in the U.S. by Inverness Medical Innovations. Chembio also manufactures rapid tests for veterinary tuberculosis and chagas disease. In March 2007 Chembio was issued a U.S. patent for the Dual Path Platform (DPP™), a next-generation lateral flow platform. DPP has demonstrated significant advantages over currently available lateral-flow methods, including increased sensitivity, sample flexibility and multiplexing capabilities. For additional information please visit www.chembio.com

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.

Contact Information

  • Contacts:

    Company Contact:
    Chembio Diagnostics, Inc.
    Matty Arce
    (631) 924-1135, ext. 123
    www.chembio.com

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    Anne Marie Fields
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    (310) 691-7100