OraSure Technologies to Participate in U.S. Trade Mission to Africa; -OraSure to Highlight OraQuick Rapid HIV Antibody Test-
OraSure Technologies is the manufacturer of the OraQuick® Rapid HIV Antibody Test, a point-of-care test device that can detect antibodies to HIV within 20 minutes. It is the only rapid device in the world designed to use oral fluid, whole blood, serum or plasma samples. OraQuick® was first introduced for sale internationally at the AIDS Conference in Durban, South Africa in July 2000.
Dr. Sam Niedbala, Executive Vice President and Chief Science Officer of OraSure Technologies, will represent the Company on this mission. "We welcome the opportunity to represent the United States with Secretary Evans on this very important mission to Africa," said Dr. Niedbala. "We believe that our OraQuick® Rapid HIV Antibody Test can assist this region of the world where HIV/AIDS is such a serious issue."
Mike Gausling, President and CEO of OraSure Technologies, stated, "We are proud to have been chosen to join the U.S. delegation and look forward to the opportunity to highlight our OraQuick® Rapid HIV Antibody Test to foreign governments and companies doing business throughout Africa."
Globally, 40 million adults and children were living with HIV/AIDS at the end of 2001, and approximately 70 percent of those persons were located in Sub-Saharan Africa, according to a 2001 report from UNAIDS. The HIV prevalence rate in some African countries is as high as 30 percent, which will require a significant resource commitment to prevention and testing, orphan care and medical care.
OraSure's OraQuick® HIV test has been through extensive trials in the United States, Africa, and Thailand. Furthermore, OraSure has been a major supplier of rapid HIV tests to the CDC-sponsored LIFE (Leadership and Investment in Fighting an Epidemic) Initiative, a $100 million U.S. investment in sub-Saharan African countries working to prevent the further spread of HIV and provide care for those impacted by the disease. OraQuick® is also being used in the CDC's MIRIAD (Maternal Infant Rapid Intervention at Delivery) Project to test pregnant women for HIV.
The Company has submitted a pre-market application for FDA approval for use of the OraQuick® Rapid HIV-1 Antibody Test in the United States with finger-stick whole blood samples. In May 2002, OraSure received notification from the FDA that the OraQuick® Rapid HIV-1 Antibody Test is approvable in the United States, subject to the Company meeting certain conditions. The Company has been working to address all FDA observations in order to permit receipt of final approval as soon as possible.
About OraSure TechnologiesOraSure Technologies develops, manufactures and markets oral fluid specimen collection devices and tests and diagnostic products using its proprietary technologies, including immunoassays and other in vitro diagnostic tests and other medical devices. These products are sold in the United States and certain foreign countries to government agencies, clinical laboratories, physicians' offices, hospitals, commercial and industrial entities, and various distributors.
OraSure Technologies is the leading supplier of oral fluid collection devices and assays to the life insurance industry and public health markets for the detection of antibodies to HIV-1. In addition, the Company supplies oral-fluid testing solutions for drugs of abuse testing. For more information on the Company, please go to www.orasure.com.
Important InformationThis press release contains certain forward-looking statements, including with respect to sales, markets, products, and regulatory submissions and approvals. Actual results could be significantly different. Factors that could affect results include the ability to market products; impact of competitors, competing products and technology changes; ability to develop, commercialize and market new products; market acceptance of oral fluid testing or other products; ability to fund research and development and other projects and operations; ability to obtain and timing of obtaining necessary regulatory approvals; ability to develop product distribution channels; uncertainty relating to patent protection and potential patent infringement claims; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally; loss or impairment of sources of capital; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; changes in relationships with strategic partners and reliance on strategic partners for the performance of critical activities under collaborative arrangements; changes in accounting practices or interpretation of accounting requirements; customer inventory practices and consolidations; equipment failures and ability to obtain needed raw materials and components; the impact of terrorism and civil unrest; and general business, political and economic conditions. These and other factors are discussed more fully in the Securities and Exchange Commission filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the year ended December 31, 2001, and its most recent Quarterly Report on Form 10-Q. Although forward-looking statements help to provide complete information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
CONTACT: OraSure Technologies, Inc.
Ronald H. Spair, 610/882-1820
Investorinfo@orasure.com
www.orasure.com
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