OraQuick Rapid HIV-1 Antibody Test is Highlighted in New CDC HIV Prevention Initiative
-CDC Recommends Use of Rapid Testing as Part of
Comprehensive HIV Testing Strategy-
BETHLEHEM, Pa.--(BUSINESS WIRE)--April 28, 2003--OraSure Technologies, Inc. (Nasdaq NM:OSUR), the market leader in oral fluid diagnostics, announced today that the Centers for Disease Control and Prevention ("CDC") stated that simple, rapid HIV testing would be a key component to its new HIV testing initiative announced by the CDC on Thursday, April 17, 2003, in the CDC's Morbidity and Mortality Weekly Report ("MMWR") (April 18, 2003 / Vol. 52 / No. 15), and recognized the OraQuick (R)Rapid HIV-1 Antibody Test as the only CLIA (Clinical Laboratory Improvements Amendments of 1988) waived rapid HIV-1 test approved by the FDA.
The new CDC initiative, entitled "Advancing HIV Prevention: New Strategies for a Changing Epidemic," is aimed at making HIV tests a more routine part of medical practice for pregnant women and the estimated 200,000 people in the United States who currently have the HIV virus but may be unaware that they are infected. The initiative expands on current HIV prevention strategies and encourages the more widespread use of rapid HIV testing.
"We applaud the CDC's new HIV testing initiative and are eager to continue working in partnership with the CDC to make rapid HIV testing available to all who need it," said Mike Gausling, President and Chief Executive Officer of OraSure Technologies. "As the only CLIA waived, rapid, point-of-care HIV-1 test, OraQuick(R) will be crucial for HIV testing in non-traditional settings, where simplicity and mobility are critical factors."
"This new initiative is exciting and it capitalizes on new, rapid testing technologies; provides us the opportunity to reduce barriers to testing; enhances prevention services; and continues to prevent mother-to-child HIV infections," said Harold Jaffe, M.D., director of CDC's National Center for HIV, STD, and TB Prevention. (CDC Press Release, 4/17/2003)
The CDC has identified $35 million to support the new HIV testing strategy. As part of this comprehensive initiative, the CDC announced that in 2003 it will fund new demonstration projects using OraQuick(R) to increase access to early diagnosis and referral for treatment and prevention services in high-HIV prevalence settings, including correctional facilities. (MMWR, April 18, 2003)
The initiative has four parts, and will be implemented by several agencies working together within the Department of Health and Human Services. It includes making HIV testing a routine part of medical care; creating new models for diagnosing HIV infections outside medical settings; preventing new infections by working with people diagnosed with HIV and their partners; and further decreasing mother-to-child HIV transmission by incorporating HIV testing in the routine battery of prenatal tests.
On Thursday, April 24, 2003, the CDC hosted a satellite broadcast and web cast entitled, "Update on Rapid Testing for HIV." The 2-hour forum was co-sponsored by the CDC and the Public Health Training Network, and described rapid tests for HIV including availability, administration, benefits and limitations; implementation considerations for counseling and testing; confirmatory testing for positive test results; quality assurance and training; and resources for updates on rapid testing. The broadcast featured presentations, interviews and panel responses to audience questions and a replay may be accessed through a link at http://legacy.cdcnpin.org/broadcast/current/2003/0424/start.htm.
OraQuick(R) is the first FDA-approved rapid, point-of-care test designed to detect antibodies to HIV-1 in finger-stick whole blood within approximately 20 minutes. OraSure received FDA approval of the OraQuick (R)test on November 7, 2002. On January 31, 2003, OraSure received a CLIA waiver for the test, permitting its use by more than 180,000 sites in the United States, including outreach clinics, community-based organizations and physicians' offices.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies and diagnostic products, 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 various distributors, government agencies, clinical laboratories, physicians' offices, hospitals, and commercial and industrial entities.
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 Information
This press release contains certain forward-looking statements, including with respect to sales, markets and products. 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; 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 and its Annual Report on Form 10-K for the year ended December 31, 2002. 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. Investor Contact: Ronald H. Spair, 610/882-1820 Investorinfo@orasure.com www.orasure.com or OraSure Technologies, Inc. Media Contact: William Bruckner, 610/882-1820 wbruckner@orasure.com SOURCE: OraSure Technologies, Inc.
