CDC Selects OraQuick as One of Two Rapid HIV Tests for Treatment Investigational Device Exemption Submittal.

Business Editors, Health/Medical Writers

BETHLEHEM, Pa.--(BW HealthWire)--March 15, 2001

OraQuick Selected After Accuracy Validated in Studies

Conducted by CDC Over Past Year

OraSure Technologies, Inc. (Nasdaq:OSUR), announced that the Centers for Disease Control and Prevention (CDC) has selected the OraQuick HIV-1/2 rapid HIV test to be used in the CDC sponsored Treatment Investigational Device Exemption (IDE).

Under federal regulations, the FDA can authorize the use of an investigational test in the treatment of patients with serious or life-threatening conditions when no comparable or satisfactory alternative exists. The CDC has determined that the absence of approved rapid HIV tests in the United States meets that definition and has received permission from the FDA to use the OraQuick HIV-1/2 device for specific purposes where rapid tests are uniquely required.

The CDC has identified key areas of focus for the use of OraQuick in its IDE. Public hospitals in five U.S. Metropolitan areas with relatively high HIV seroprevalance among pregnant women will be targeted for delivery room testing. AIDS service organizations, community based organizations, as well as outreach programs will also be a focus. The CDC will also offer the OraQuick test in settings such as selected hospital emergency departments and outpatient clinics.

OraQuick HIV-1/2 was selected after its accuracy was validated in studies conducted by the CDC over the past year. Robert D. Thompson, Chief Executive Officer for the Company stated, "OraSure is pleased to participate with the CDC and the FDA in the effort to make these highly accurate and critically needed tests available in the United States. During the period covered by the IDE, OraQuick will gain credibility and early exposure in the U.S. market, which will help OraQuick gain rapid acceptance once it receives FDA clearance. "

The CDC stated in their IDE application that critical decisions about treatment in a number of clinical settings depend on the availability of immediate HIV test results. Implementation of prenatal counseling and voluntary HIV testing, and the use of zidovudine regimens to prevent HIV transmission resulted in a steep decline in new cases of AIDS in infants during the 1990s in the United States.

However, an estimated 10% to 20% of pregnant women do not know their HIV status at the time of delivery. Expedited testing with rapid HIV tests will permit therapy to be initiated for these mothers during labor, and after birth in their infants. This will substantially reduce the chance that these infants will become infected with HIV.

Rapid HIV test results are also necessary for deciding whether to initiate treatment for health care workers after accidental exposures to patient body fluids. Treatment with antiretroviral drugs initiated as soon as possible after exposure decreased the risk of HIV transmission to healthcare workers. Conversely, unnecessary treatment exposes the health care worker to the risk of serious side effects. The U.S. Public Health Service recommends testing the source patient with a rapid HIV antibody test to help select the proper course of action.

There is also a need for rapid HIV tests to also assist with diagnosis and appropriate treatment of persons who may have opportunistic infections due to AIDS in urban emergency departments, which have been shown to have high rates of undiagnosed HIV infection among their patient populations.

The value of rapid tests in public health is well established. The CDC estimates that nearly one third of the estimated 800,000 to 900,000 HIV-infected persons in the United States have not been tested for HIV and thus cannot benefit from early intervention with effective antiviral therapy.

About OraSure

OraSure Technologies, Inc. develops, manufactures and markets medical devices and diagnostic products for use by public- and private-sector clients, clinical laboratories, physicians' offices and workplace testing. 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 visit www.orasure.com.

This press release contains certain forward-looking statements, including with respect to product development, performance, benefits and markets. Actual results could be significantly different. Factors that could affect results include 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 obtain and the 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 collaborate arrangements; changes in accounting practices or interpretation of accounting requirements; equipment failures and ability to obtain needed raw materials and components; and general business and economic conditions. These and other factors are discussed more fully in the Securities and Exchange Commission (SEC) filings of OraSure Technologies, including the Registration Statement on Form S-4 filed with the SEC on August 31, 2000 and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2000, and in the Epitope, Inc. Annual Report on Form 10-K for 1999. 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.