OraSure Technologies Receives Order from Centers for Disease Control; OraQuick Device To Be Used As Part of LIFE Initiative
BETHLEHEM, Penn.--(BW HealthWire)--April 4, 2001--OraSure Technologies, Inc. (Nasdaq:OSUR) announced that the company has received an initial order from the Centers for Disease Control for 118,000 OraQuick(R) HIV-1/2 devices, in conjunction with the LIFE (Leadership and Investment in Fighting an Epidemic) Initiative.
OraQuick HIV-1/2 is a rapid test device that can detect antibodies to the HIV disease within 20 minutes, and is the only rapid device in the world that uses either oral fluid, whole blood, serum or plasma samples.
Introduced in July 1999, the LIFE Initiative is a major U.S. effort to address the global AIDS epidemic. The initiative invests approximately $100 million in U.S. support for India and sub-Saharan African countries working to prevent the further spread of HIV and provide care for those impacted by the disease. The LIFE Initiative is one of the many internationally funded projects now addressing the AIDS epidemic in Africa.
"The CDC's main objectives in the Initiative are to decrease HIV incidence in 15- to 24-year-olds, reduce perinatal infections, decrease STDs, and build community support for people caring for children affected by AIDS. OraSure is proud to have OraQuick included in this leading-edge initiative," stated Robert D. Thompson, Chief Executive Officer of the OraSure Technologies.
Countries included in the initiative are Botswana, Cote d'Ivoire, Ethiopia, India, Kenya, Malawi, Mozambique, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Uganda, Zambia and Zimbabwe.
This initiative involves an unprecedented collaboration between the United States Agency for International Development (USAID), Department of Health and Human Services (HHS), and Department of Defense (DOD). Of the $100 million invested in the Initiative, $35 million will be programmed through the CDC, the lead agency for HHS, with collaboration from the United States Health Resources and Services Administration (HRSA).
The major areas of focus in the initiative will include primary prevention such as mother-to-child transmission, STD management, HIV prevention for youth, and blood safety systems. Capacity and infrastructure development, such as enhancing surveillance systems, strengthening laboratory capacity and training of public health workers, will also be areas of focus, as will community and home-based care and treatment programs.
Other OraQuick Items
The Company previously announced that the OraQuick device was selected for use in the Treatment IDE filed by the CDC with the FDA, which is separate from the CDC's LIFE Initiative program.
OraSure also issued a clarification with regard to an independent study (Dewitt, O'Connell, et. al.) presented at the 8th Conference on Retroviruses and Opportunistic Infections earlier this month. The study demonstrated sensitivity of 96% for the OraQuick device on a population of heavily treated subjects. Those patients were already identified as HIV positive and were under drug therapy.
"The Company does not dispute the findings of this study, but would like to underscore that known positive subjects already receiving drug therapy do not represent the target market for OraQuick. The product is specifically designed as a screening tool to test mass populations of unknown HIV status," said Robert D. Thompson, Chief Executive Officer for the Company.
OraSure has also successfully completed its clinical trial for the OraQuick HIV-1/2 rapid device with the National Institute for Virology (NIV) in South Africa. The NIV functions as the national resource center for viral diseases in South Africa, and is a pubic health institute within the Department of Health providing comprehensive medical virological diagnostic services. This clinical trial is a requirement for companies to participate in the public tender business in South Africa. The company intends to pursue such opportunities through its distributor Edison Africa.
For an electronic copy of this release or for further information on the Company, please visit our newly updated corporate website at www.orasure.com.
About OraSure
OraSure Technologies, Inc. develops, manufactures and markets medical devices and diagnostic products for use by public- and private-sector clients, clinical laboratories, physicians' offices and workplace testing. 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. In addition, the company supplies oral fluid testing solutions for drugs-of-abuse testing. For more information on the company please visit www.orasure.com.
CONTACT:OraSure Technologies
Michelle Sells, Manager, Investor Relations
503/641-6115
Investorinfo@orasure.com
www.orasure.com
or
Rich Hooper, Chief Financial Officer, 610/882-1820
