Chembio Diagnostic Systems, Inc. (OTCBB: CEMI) develops, manufactures and markets rapid tests for the detection of HIV and certain other infectious diseases. The company's current products are based upon single path lateral flow, rapid test technology platforms using proprietary and/or in-licensed technology. Chembio's patented Dual Path Platform (DPP™) is now being employed to develop several new high performance rapid test products in collaboration with others.

Chembio's HIV assays have been incorporated into the World Health Organization (WHO) Bulk Procurement Scheme and the USAID blanket Waiver List which allows them to be procured with U.S. government funds. Two of the company's assays have been approved by the U.S. FDA for sale in the United States. This enables the company to participate in the growing U.S. market which is estimated to be a $50 million market.

Chembio Diagnostic Systems, Inc. operates a cGMP/QS (Good Manufacturing Facility/Quality Systems) manufacturing facility that is registered with the US FDA (Food and Drug Administration). The facility includes dedicated cGMP process manufacturing, Quality Control and R&D laboratories. The company manufactures class II and class III in vitro diagnostic devices.

A commitment to Innovative Partnerships

Strategic alliances are a key element in Chembio’s business strategy.

Chembio announced an agreement in October of 2006 to partner with Inverness Medical Innovations, the global leader in marketing point of care diagnostic tests, for Chembio's FDA-approved rapid HIV tests.   The products were launched Q1 of 2007. New CDC recommendations for routine HIV testing and new FDA guidelines that have opened up the over-the-counter market have expanded the U.S. and global market opportunity significantly.

Chembio has initiated strategies to participate in the US President's Emergency Plan for Aids Relief (PEPFAR) and the UN Global Fund initiatives. 

In January 2008, Chembio Diagnostics, Inc. and the Bio-Manguinhos unit of the Oswaldo Cruz Foundation of Brazil 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(TM)) technology. Previously, in 2004, Bio-Manguinhos and Chembio entered into a similar agreement concerning one of Chembio's HIV rapid tests.



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In addition, Chembio is collaborating with some of the world's leading scientists in the development of rapid assays for detecting other infectious diseases, both human and veterinary. The company has developed a rapid test for Chagas disease which is endemic in much of Latin America and affects 16 to 18 million people, killing 50,000 annually. The attributes of the Chagas STAT-PAK assay make it ideal for use in resource poor settings. In December 2005, Chembio received a $1.2 million order from an affiliate of the World Health Organization. The assay was used to screen Bolivian children living in areas where the disease is endemic.

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R&D Pipeline

In November 2006 Chembio announced an agreement with the United States Centers for Disease Control and Prevention (CDC) to develop a rapid, point of care combination screening and confirmatory test for Syphilis. The test will combine CDC's patented antigens with Chembio's patented DPP™ technology. The company believes that the DPP™ technology will enable the development of next-generation rapid tests, including an oral fluid HIV test under development, which will provide high sensitivity levels as compared with standard single path lateral flow tests.

Pipeline of Other Rapid Test Products & Technologies

The Company has additional opportunities in world markets for rapid testing for Tuberculosis (human and veterinary), Chagas disease and certain other areas where the Company has proprietary rapid tests and related technologies in development. Chembio recently introduced its patented DPP rapid test technology as a means of developing more sensitive tests for infectious diseases and other conditions.

In 2006, Chembio's revenues grew to over $6MM from $3.4MM in 2005 primarily as a result of international rapid HIV and Chagas disease product sales. In 2007, sales of the FDA approved HIV tests are commencing in the U.S. through Inverness Medical Innovations (www.invernessmedicalpd.com/poc). Inverness, which has the largest point of care marketing organization in the United States, launched these products in Q1 of 2007.

Commitment to Global Availability 

Chembio supplies countries with rapid tests at competitive prices through both traditional and nontraditional distribution channels and builds alliances in developing countries that have been significantly impacted by the HIV pandemic. Due to the rapid spread of HIV/AIDS and the need for increased testing and subsequent ARV treatment in Africa, the company established a Marketing and Business Development Office in the region. Located in Nigeria, this office works closely with both governmental and nongovernmental entities to help provide a sustained supply of HIV rapid tests in the region.

In September 2005, Chembio's HIV 1 /2 STAT-PAK® assay was officially integrated into Uganda's national testing algorithm by the country's Ministry of Health. Currently, the Company's tests have been incorporated into Brazil's and Nigeria's national testing algorithms and are being evaluated in several other countries.

In 2005, the G8 nations declared the goal of getting "as close as possible to universal access to treatment for all those who need it by 2010." As countries scale up antiretroviral therapies to meet the treatment needs of people living with HIV/AIDS, they must also scale up their HIV testing. It is critical that a steady supply of simple, accurate rapid tests are available to meet the increased demand for testing.


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