OraSure Receives FDA Approval to Transfer Manufacturing

BETHLEHEM, Pa.--(BUSINESS WIRE)--March 10, 2004--OraSure Technologies, Inc. (Nasdaq NM:OSUR), the market leader in oral fluid diagnostics, announced that the U.S. Food and Drug Administration ("FDA") has approved the transfer of manufacturing of its OraSure(R) HIV-1 oral specimen collection device from Oregon to the Company's Bethlehem, Pennsylvania facilities. In late 2003, the Company also received approval to transfer manufacturing of its oral fluid Western blot HIV-1 confirmatory test to Pennsylvania.

With the receipt of these FDA approvals, the Company is now permitted to manufacture its OraSure(R) and Western blot products in Pennsylvania. The manufacturing of the first commercial lots for these products is expected to occur by April 2004. As a result of the transfer, the Company expects to add approximately 20 new manufacturing jobs at its Bethlehem, Pennsylvania facilities.

"The transfer of our manufacturing operations has been a lengthy and complex process and we are very pleased to have received the final FDA approval required for the transfer," said Mike Formica, Executive Vice President, Operations of OraSure Technologies. "Once the transfer is complete, we expect to realize approximately $1 million in annual cost savings. By consolidating these product lines in Pennsylvania, we will also have greater control over the quality of our products."

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 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 products, operations, jobs and expenses. 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 (including our ability to implement a direct sales effort or other alternative distribution for OraQuick(R)); 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 (including HIV-2 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.

    CONTACT: OraSure Technologies, Inc.
             Investor Contact:
             Ronald H. Spair, 610-882-1820
             Investorinfo@orasure.com
             www.orasure.com
             or
             Media Contact:
             William F. Bruckner, 610-882-1820
             wbruckner@orasure.com

    SOURCE: OraSure Technologies, Inc.