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.