OraSure Technologies Provides Update on Clinical Development Programs and OraQuick Manufacturing

Business Wire, June 25, 2009

The FDA recently reviewed the data from the observed use study at a meeting of its senior management. Following this meeting, the FDA contacted the Company and indicated that both the results of the observed use study and the Company’s remaining clinical activities should also be reviewed and approved by the Blood Products Advisory Committee (“BPAC”), an advisory committee to the FDA, before proceeding.

The Company will meet with the FDA to discuss plans for the upcoming BPAC meeting. The Company intends to gain alignment with the FDA on the next steps required to complete and file a PMA application, before presenting a proposal at the BPAC’s meeting scheduled for November 2009.

OraQuick ADVANCE® HIV Manufacturing

The Company recently has been experiencing an intermittent difficulty in manufacturing a component required for its OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test that meets the Company’s internal quality requirements. This issue initially resulted in lower production yields, but the Company was able to manufacture sufficient product to meet existing customer demand. More recently, however, the Company has experienced additional difficulty in manufacturing this component. A multi-functional team has been working aggressively with the assistance of outside consultants to resolve this manufacturing issue. Because this issue has not yet been satisfactorily resolved, inventory levels have been reduced and the Company has been allocating available product among its customers. In addition, until this issue is satisfactorily resolved, the Company will be assisting customers in meeting their HIV testing needs.

The Company’s priority has been and continues to be to provide the highest quality product to its customers in compliance with all applicable legal and regulatory requirements. Only OraQuick ADVANCE® devices that meet the Company’s stringent quality standards have been and will be released into the field.

If the Company is unable to resume full-scale production of its OraQuick® HIV test this week, its revenues for the second quarter of 2009 will be negatively impacted. In addition, in view of the foregoing, the Company expects gross margin for the second quarter to be negatively impacted due primarily to higher unabsorbed production costs and scrap expenses.

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.