Abbott and OraSure Technologies Enter Agreement for OraQuick(R) ADVANCE(TM) Rapid HIV-1/2 Test
ABBOTT PARK, Ill., and BETHLEHEM, Pa., Feb. 14 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) and OraSure Technologies (Nasdaq: OSUR) today announced an agreement for the distribution of OraSure Technologies' OraQuick(R) ADVANCE(TM) rapid antibody test for the detection of antibodies to the Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2). Under the terms of the distribution agreement, Abbott was appointed as exclusive distributor of the OraQuick(R) ADVANCE(TM) HIV-1/2 test for hospitals and as a non-exclusive distributor to physician offices in the United States.
"We believe this agreement will enable us to capitalize on the growing demand for our new OraQuick(R) ADVANCE(TM) test and help achieve our goal of making rapid HIV testing available to all who need it," said Douglas A. Michels, President and CEO of OraSure Technologies. "With the sales and marketing teams from OraSure and Abbott working together, we will expand the reach of this product in the United States."
Providing results in as little as 20 minutes, OraQuick(R) ADVANCE(TM) is the only rapid, point-of-care test for the detection of antibodies to both HIV-1 and HIV-2 approved by the U.S. Food and Drug Administration (FDA) for use on oral fluid, finger stick or venipuncture whole blood, and plasma specimens. The test is also CLIA (Clinical Laboratory Improvements Amendments Act of 1988) waived for all specimen types except plasma. OraSure commercially launched the OraQuick(R) ADVANCE(TM) test in October 2004.
"This agreement allows us to provide an important test to assist in the rapid detection of HIV," said Michael J. Collins, vice president, U.S. Diagnostic Commercial Operations, Abbott. "The test's flexibility with sample type, including oral fluid, and its ability to screen for both HIV-1 and HIV-2 make it an ideal fit for hospitals, providing them with a simple, yet comprehensive, rapid HIV test."
Under the agreement, OraSure Technologies will sell the OraQuick(R) ADVANCE(TM) to physician offices on a non-exclusive basis and exclusively to the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Administration, community based organizations, state and county public health departments, correctional and criminal justice facilities, clinics and other public health customers. Other terms of the agreement were not disclosed.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, 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 HIV. In addition, the Company supplies oral-fluid testing solutions for drugs of abuse testing. For more information on the Company, please go to http://www.orasure.com .
About Abbott
A leader in HIV/AIDS research since the early years of the epidemic, Abbott has continually improved the diagnostic effectiveness of its tests, targeting sensitivity to detect HIV infections earlier and developing advanced technology to automate HIV testing for patient diagnosis, managing therapy and screening donated blood. Abbott also has developed two protease inhibitors for the treatment of HIV/AIDS.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com .
Private Securities Litigation Reform Act of 1995 --
A Caution Concerning Forward-Looking Statements
Abbott
Some statements in this news release may be forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Exhibit 99.1 of our Quarterly Report on Securities and Exchange Commission Form 10-Q for the quarter ended Sept. 30, 2004, and are incorporated by reference. We undertake no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
OraSure
This press release contains certain forward-looking statements, including with respect to products, sales and markets. 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 products and up-converting phosphor technology products; ability to fund research and development and other projects and operations; ability to maintain new or existing product distribution channels; reliance on sole supply sources for critical product components; availability of related products produced by third parties; ability to obtain and timing of obtaining necessary regulatory approvals; ability to comply with applicable regulatory requirements; history of losses and ability to achieve sustained profitability; volatility of our stock price; uncertainty relating to patent protection and potential patent infringement claims; ability to obtain licenses to patents or other technology; 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; ability to meet financial covenants in agreements with financial institutions; ability to retain qualified personnel; 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 consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; ability to complete consolidation or restructuring activities; ability to identify, complete and realize the full benefits of potential acquisitions; and general political, business and economic conditions. These and other factors are discussed more fully in the Securities and Exchange Commission ("SEC") filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the year ended December 31, 2003, its Quarterly Reports on Form 10-Q, and its other filings with the SEC. 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.
