ORASURE TECHNOLOGIES INC

8-K · osur-20260611.htm iXBRL

0001116463 2026-06-11 2026-06-11

 UNITED STATES
 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): June 11, 2026     
 OraSure Technologies, Inc.
 (Exact Name of Registrant as Specified in Charter)

 Delaware
 001-16537
 36-4370966

 (State or Other Jurisdiction
 of Incorporation)
 (Commission
 File Number)
 (I.R.S. Employer
 Identification No.)

 220 East First Street
 Bethlehem , Pennsylvania
 18015-1360

 (Address of Principal Executive Offices)
 (Zip Code)

 Registrant’s telephone number, including area code: 610 - 882-1820
 N/A
 (Former name or former address, if changed since last report)
 Securities registered pursuant to Section 12(b) of the Act:

 Title of each class
 Trading
 Symbol(s)
 Name of each exchange on which registered

 Common Stock, $0.000001 par value per share
 OSUR
 The Nasdaq Stock Market LLC

 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:
 o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 Indicate by a check mark whether the Registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 Emerging growth company o
 If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

 Item 8.01 Other Events.

 On June 11, 2026, OraSure Technologies, Inc. (the “Company”) announced U.S. Food and Drug Administration (“FDA”) clearance of the Company’s Colli-Pee™•Dx Urine Collection Kit from its subsidiary DNA Genotek Inc., for use with Roche Molecular Systems, Inc. (“Roche”) tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium and run on Roche’s cobas ® 5800, 6800, and 8800 molecular diagnostic systems. The FDA-cleared collection kit supports at-home self-collection of first-void urine, enabling convenient at-home sample collection for both male and female patients.

 SIGNATURE
 Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 ORASURE TECHNOLOGIES, INC.

 Date: June 11, 2026 By: /s/ Carrie Eglinton Manner
 Carrie Eglinton Manner
 President and Chief Executive Officer