OraSure Technologies Inc. has submitted two separate applications to the U.S. Food and Drug Administration (FDA) for regulatory review at the end of 2025. The applications seek clearance for OraSure's rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG), as well as the Colli-Pee™ at-home urine collection device for sexually transmitted infections (STIs). The self-test is designed to deliver results in approximately 30 minutes using a self-collected swab and a disposable, over-the-counter device, while the Colli-Pee™ device aims to provide a convenient option for at-home urine collection. Both submissions are part of OraSure’s efforts to expand accessible and private diagnostic testing options.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. OraSure Technologies Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9619511-en) on January 05, 2026, and is solely responsible for the information contained therein.