Chembio Diagnostic Systems, Inc. (OTCBB: CEMI) develops, manufactures, licenses and markets point-of-care (POC) diagnostic tests and technology for the detection of infectious diseases. Chembio entered the POC testing field in the late 1990s and, in 2002, focused its business on the emerging global need and opportunity for rapid HIV tests. As a result of this focus during the next five years, from 2003 through 2008, Chembios total revenues grew at a compounded annual growth rate of 23%, surpassing $11M in 2008. The company's Dual Path Platform (DPP®) POC technology enables development of POC assays that provide unique features and capabilities such as multiplexing and improved control of challenging sample types, such as oral fluid. Several new tests have already been developed on DPP® including a new oral fluid HIV 1/2 test, a new five-band POC confirmatory test for HIV 1/2, and a combination screening and confirmation test for Syphilis. Prototypes of an oral fluid test for Hepatitis C and various strains of influenza have also been developed. Chembio is therefore now positioned to participate in the broader growing global market for POC diagnostic testing with this patented technology. The demand for point of care diagnostic products is increasing as a way to improve prevention efforts and thereby lower the costs of health care through earlier, easier and faster diagnosis. Chembios products are designed and manufactured in accordance with these agencies relevant quality standards as well as ISO-13.485. Chembios HIV tests have been selected in the national testing protocols of several countries in Africa, Asia and Latin America. International relief efforts, led by the Presidents Emergency Plan for Aids Relief (PEPFAR) and the UN Global Fund to Stop HIV, TB and Malaria (the Global Fund), have made significant strides toward prevention and treatment of HIV/AIDS, for which rapid HIV tests are an essential component. In 2007, Chembio entered the United States rapid HIV test market. The companys two HIV tests that are FDA approved are based on lateral flow technology and are marketed exclusively in the U.S. by Inverness Medical Innovations, Inc. under their Clearview® brand as HIV 1/2 STAT-PAK® and COMPLETE HIV 1/2. In 2006 the United States Centers for Disease Control (CDC) revised their HIV testing guidelines by greatly expanding the recommended patient population for routine HIV testing in the U.S.. These recommendations are being adopted and implemented nationwide. Chembio is participating in this market expansion through its HIV tests that are marketed by Inverness. National Institutes of Health (NIH), the CDC, the Foundation for Innovative and Novel Diagnostics (FIND), and the Infectious Disease Research Institute (IDRI). Work with these organizations involves efforts to develop rapid POC tests, all on DPP®, for Tuberculosis, Malaria, Leprosy, Leishmaniasis, Leptospirosis, Syphilis, HIV, Influenza, Hepatitis C, and other conditions in humans and animals. In each instance there is a demonstrated need for a simple, accurate, cost effective rapid diagnosis at the point of care. Chembio has a new oral fluid HIV test which it developed with its DPP® technology. International evaluations are ongoing and clinical trials for U.S. market approval are expected to begin during 2009 and continue in 2010. Also, Chembio has a Cooperative Research & Development Agreement (CRADA) with the CDC to develop the worlds first rapid, POC combination screening and confirmatory test for Syphilis. This test, DPP® Syphilis Screen & Confirm, uniquely combines two markers on a single test strip which will enable a clinician to differentiate active versus past syphilis infection from a single finger-stick whole blood sample within 20 minutes. This will enable treatment decisions to occur at the POC. Development of the syphilis test is completed and several field and other studies are scheduled in the U.S. and globally during 2009 and 2010. Chembio also has the unique experience in completing and executing technology transfer, agreements in the international market for rapid tests. These agreements ensure a cost effective means of providing local public health programs with needed POC screening and confirmatory tests by transferring know-how for the products that will ultimately be manufactured locally by Chembios customer. At the same time, these agreements provide qualified public and private entities with the ability to effectively address local conditions. To date, Chembio has concluded five such agreements with Bio-Manguinhos, an agency that is part of the Oswaldo Cruz Foundation and that is affiliated with the Brazilian Ministry of Health; other such agreements are in discussion for this and other markets.
