ORASURE TECHNOLOGIES INC

Recent Developments

•In June 2026, we received FDA clearance of our Colli-Pee™•Dx Urine Collection Kit for use with Roche’s STI tests for Chlamydia trachomatis(CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG). The FDA-cleared collection kit enables convenient at-home self-collection of first-void urine by both male and female patients. Specimens can be collected at any time of day in the privacy of the home or any other private setting and are intended for testing on the Roche cobas molecular diagnostics platform.

•In July 2026, we received Emergency Use Authorization from the FDA for our second generation OraQuick™ Ebola 2.0 Rapid Antigen Test for use with whole blood in live patients, as well as cadaveric oral fluid for individuals suspected to have had Ebola disease at the time of death. The test can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and Taï Forest.

•We are updating our submission plan for our InteliQuick™ CT/NG molecular self-test on the Sherlock platform to incorporate feedback received through constructive interactions with the FDA. As part of this process, in July 2026 we elected to withdraw the current submission and plan to pursue a future subm ission. Our InteliQuick™ CT/NG studies demonstrated strong performance compared with centralized laboratory molecular diagnostic methods, and we remain encouraged by the product’s performance, its differentiated profile, and its potential to serve a significant public health need.