SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): January 31, 2003 OraSure Technologies, Inc. -------------------------- (Exact name of issuer as specified in charter) DELAWARE 1-10492 36-4370966 (State or Other (Commission (I.R.S. Employer Jurisdiction file Identification of Incorporation or number) Number) Organization) 220 East First Street Bethlehem, Pennsylvania 18015-1360 (Address of principal executive offices) (610) 882-1820 (Registrant's telephone number, including area code) Item 5 - Other Events. OraSure Technologies, Inc. (the "Company") issued a press release on January 31, 2003, announcing that it had submitted an application to the U.S. Food and Drug Administration (the "FDA") for a waiver under the Clinical Laboratory Improvements Amendments of 1988 ("CLIA") for the Company's OraQuick(R) Rapid HIV-1 Antibody Test (the "OraQuick(R) Test"). A copy of the press release is attached to this Report as Exhibit 99.1 and is incorporated herein by reference. The Company issued a second press release on January 31, 2003, announcing that the FDA has approved the Company's application for a CLIA waiver for the OraQuick(R) Test. A copy of the press release is attached to this Report as Exhibit 99.2 and is incorporated herein by reference. Signatures Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized. OraSure Technologies, Inc. Date: January 31, 2003 By: /s/ Jack E. Jerrett ---------------------------------- Jack E. Jerrett Vice President, General Counsel and Secretary EXHIBIT INDEX Exhibit ------- 99.1 Press Release issued January 31, 2003 by OraSure Technologies announcing that it has submitted an application to the U.S. Food and Drug Administration for a waiver under the Clinical Laboratory Improvements Amendments of 1988 ("CLIA") for the Company's OraQuick(R) Rapid HIV-1 Antibody Test. 99.2 Press Release issued January 31, 2003 by OraSure Technologies announcing that the U.S. Food and Drug Administration has approved a CLIA waiver for the Company's OraQuick(R) Rapid HIV-1 Antibody Test.