OraSure Technologies Applauds CDC's Call for Routine HIV Testing; Revised HIV Testing Recommendations Advocate HIV Screening as Routine Part of Medical Care

BETHLEHEM, Pa., Sep 21, 2006 (BUSINESS WIRE) -- OraSure Technologies, Inc. (NASDAQ:OSUR), the market leader in oral fluid diagnostics and the manufacturer of the OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test, today issued a statement in support of "The Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings," issued today by the Centers for Disease Control and Prevention ("CDC"). These recommendations, which advocate routine HIV screening of patients as a normal part of medical care, were published in the CDC's Morbidity and Mortality Weekly Report (MMWR), September 22, 2006/55 (RR14); 1-17.

According to the CDC, the objectives of the revised recommendations are to normalize HIV screening as a routine part of medical care, including for pregnant women, in health-care settings; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce perinatal transmission of HIV in the United States. The recommendations are intended for all health-care providers in clinical settings, including those working in hospital emergency departments, urgent care clinics, inpatient services, substance abuse treatment clinics, public health clinics, community clinics, correctional health-care facilities and primary care settings. The full guidelines can be found at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm

"We believe the implementation of routine testing in health-care settings is an important step toward stopping the spread of HIV in America. We applaud the CDC for issuing this clear call to action, which will reduce barriers in both the public and private sector to HIV testing as a regular part of medical care," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We are confident that as a result of the revised recommendations, more individuals will get tested and learn their HIV status, and we believe our OraQuick ADVANCE(R) test can serve an important role. We look forward to working with the CDC and health care providers as they advance this initiative."

The recommendations call for routine HIV testing of all patients aged 13 to 64. In contrast, the prior CDC guidelines recommended routine testing only for high-risk persons and for those in acute-care settings where HIV prevalence exceeded one percent. The new recommendations emphasize that testing be provided on a voluntary basis with the patient's knowledge, unless the patient elects to "opt out" of the testing. It is further recommended that HIV testing be covered by a general medical care consent obtained from the patient and that pre-test counseling and a separate written consent for HIV testing no longer be required. The recommendations also contain measures intended to improve diagnosis of pregnant women and further reduce mother-to-child HIV transmission.

The development of the recommendations involved extensive input from representatives of community-based organizations, individuals living with HIV/AIDS, health departments and academia, as well as representatives from professional organizations, state and federal agencies, and other stakeholders.

OraQuick ADVANCE(R) is the first and only U.S. Food and Drug Administration 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 or plasma specimens. The CDC and the Substance Abuse and Mental Health Services Administration (SAMHSA) have effectively deployed over one million OraQuick(R) tests in various public health, drug treatment and outreach settings throughout the country. OraQuick(R) is also used by hospitals, state departments of health, clinics, community-based organizations, and college/university health centers throughout the country.

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. 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 and HIV testing. Actual results could be significantly different. Factors that could affect results include the ability to market and sell 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 new products or technology; changes in market acceptance based on product performance; continued bulk purchases by customers, including governmental agencies, and the ability to fully deploy those purchases in a timely manner; changes in relationships with strategic partners and reliance on strategic partners for the performance of critical activities under collaborative arrangements; failure of distributors or other customers to meet purchase forecasts or minimum purchase requirements for our products; ability to fund research and development and other products and operations; ability to obtain and 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 and cost of obtaining, necessary regulatory approval for new products or new indications or applications for existing products; 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; uncertainty and costs of litigation relating to patents and other intellectual property; availability of 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, patent infringement, and other types of litigation; changes in international, federal or state laws and regulations; 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, 2005, 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.

SOURCE: OraSure Technologies, Inc.

OraSure Technologies, Inc.
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