OraSure Receives HCV Patent License from Ortho-Clinical Diagnostics and Chiron Corporation; OraSure to Develop and Commercialize Rapid HCV Test

BETHLEHEM, Pa.--(BUSINESS WIRE)--Aug. 2, 2005--OraSure Technologies, Inc. (NASDAQ:OSUR), the market leader in oral fluid diagnostics, announced today that it has received a worldwide, non-exclusive license from Ortho-Clinical Diagnostics and Chiron Corporation to patents relating to the hepatitis C ("HCV") virus. Under the terms of the license, OraSure has obtained non-exclusive rights to certain HCV patents from Ortho-Clinical Diagnostics and Chiron Corporation, in exchange for the payments of upfront fees and ongoing royalties on product sales.

The license will permit OraSure to manufacture, distribute and sell a rapid, point-of-care diagnostic product to detect antibodies to HCV in both oral fluid and blood. There currently is no U.S. Food and Drug Administration ("FDA") approved rapid HCV test in the United States, and there is no rapid HCV test available anywhere in the world that can be used on oral fluid.

"Securing this HCV license gives us the opportunity to pursue and develop a rapid test for hepatitis C, one of the most common chronic bloodborne viral infections in the U.S. and abroad, and one that is seen frequently in patients who also have HIV," said Douglas A. Michels, President and CEO of OraSure Technologies. "Our goal has always been to create the most versatile and comprehensive point-of-care rapid tests in the world, and this license will enable us to expand our product offerings to include HCV diagnostics."

First identified by Chiron scientists in 1987, HCV is the causative agent for what was formerly known as non-A non-B hepatitis. HCV is a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer. There is no known vaccine to prevent HCV.

Globally, an estimated 170 million persons, or 3 percent of the world's population, are chronically infected with HCV and three to four million people are newly infected each year, according to the World Health Organization.

OraSure, the market leader in oral fluid diagnostics, launched the OraQuick(R) ADVANCE(TM) Rapid HIV-1/2 Antibody Test in October 2004, the first and only FDA-approved and CLIA (Clinical Laboratory Improvements Amendments Act of 1988) waived rapid, point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood and plasma specimens. OraSure believes that its OraQuick(R) platform may be used for the diagnosis of other infectious diseases, including HCV.

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.

Important Information About OraSure Technologies

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, 2004, 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 Contacts:
Ron Ticho, 610-882-1820
rticho@orasure.com
or
Jennifer Moritz, 718-623-0355
jmoritz@0to5.com

SOURCE: OraSure Technologies, Inc.