is a US company serving the increasing global demand for rapid tests needed for the effective prevention and treatment of infectious diseases, and other conditions. Chembio’s focus is on developing, manufacturing and marketing tests for the rapid, simple and cost-effective detection of HIV, Tuberculosis (human and veterinary), and certain other Neglected Diseases. Chembio has a proven commitment toward ensuring sustainable supplies of high quality rapid tests to those who need them by using innovative, socially responsible strategies.
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 manufacturers class II and class III in vitro diagnostic devices.
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 US government funds. In 2006, Former President Bill Clinton announced that his foundation’s HIV/AIDS Initiative negotiated new pricing agreements to lower the prices of HIV diagnostics and two antiretrovirals (ARVs). These products and pricing include Chembio’s STAT-PAK® HIV 1 / 2 Dipstick. The Foundation’s Procurement Consortium currently includes 50 developing countries around the world.
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Former President Clinton Announces New Agreements to
Lower Prices of HIV/AIDS Rapid Tests and Second-Line Drugs
Chembio has initiated strategies to participate in the US President’s Emergency Plan for Aids Relief (PEPFAR) and the UN Global Fund initiatives. In February 2004, a 13-year technology transfer and supply contract was signed with Bio Manguinhos—one of the world’s largest manufacturers of vaccines and an affiliate of the Brazilian Ministry of Health.
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 will be used to screen Bolivian children living in areas where the disease is endemic.
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Chembio is successfully leveraging the knowledge gained through years of basic NIH-funded research by its scientists which will result in the production of a series of rapid veterinary TB products. TB is one of the most widely spread infectious diseases and affects both animals and humans. Worldwide TB is recognized as a serious zoonotic (naturally communicable to humans from animals), economic, social and regulatory concern in that it can affect such a broad range of host species. It is transmittable between animals and humans.
In November 2005, Chembio’s rapid veterinary TB test was recommended by the United States Animal Health Association (USAHA) TB Scientific Advisory Subcommittee (SAS) to the USDA for use as an ancillary diagnostic to the tuberculin skin test. These assays will more quickly and accurately detect TB in cattle, white-tail deer, elk, red deer and exotic animals. Chembio filed a patent application for this unique technology in 2005.
Chembio has also worked with partners who will provide local assembly or packaging of products developed by the company. At Chembio, we believe that fostering self-reliance through strategic relationships enables countries to meet their own healthcare needs while providing jobs and economic growth for their citizens.
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. In January 2006, the company was selected by Former President Clinton’s HIV/AIDS initiative to make rapid HIV tests available to 50 countries on 4 continents. Due to the rapid spread of HIV/AIDS and the need for increased testing and subsequent ARV treatment in Africa, the company established two Marketing and Business Development Offices in the region. These offices, located in Nigeria and Tanzania, will work 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. In October, 2005, Chembio donated 10,000 HIV 1 /2 STAT-PAK® tests to the Infectious Disease Institute (IDI) of Uganda. This donation reinforces the company’s mission to make HIV tests available to those who need them.
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. Chembio Diagnostic Systems, Inc. is committed to fulfilling that need.
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