Form 8-K
8-K — ORASURE TECHNOLOGIES INC
Accession: 0001116463-26-000046
Filed: 2026-06-11
Period: 2026-06-11
CIK: 0001116463
SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)
Item: Other Events
Documents
8-K — osur-20260611.htm (Primary)
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8-K
8-K (Primary)
Filename: osur-20260611.htm · Sequence: 1
osur-20260611
FALSE000111646300011164632026-06-112026-06-11
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
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