OraSure Submits Rapid Self-Test Applications for FDA Clearance

OraSure Technologies submitted two separate applications at the end of 2025 to the U.S. Food and Drug Administration for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae as well as its Colli-Pee at-home urine collection device for sexually transmitted infections. OTI's rapid self-test for CT/NG is built on the Sherlock molecular diagnostics platform and is designed to provide results in approximately 30 minutes in a disposable, over-the-counter format. The test uses a self-collected swab, and results can be read directly on the hand-held testing device without the need for an electrical connection, enhancing flexibility and convenience. OTI estimates that testing for CT/NG represents a total addressable market of more than $1.5B. Today, the vast majority of CT/NG tests in the U.S. are processed in centralized laboratories, creating an opportunity for meaningful market expansion through the introduction of an affordable rapid self-test. OTI also submitted the Colli-Pee device, which is designed for at-home urine collection and is aligned with patient preferences for private and convenient diagnostic testing. The submission covers multiple STI indications and is being pursued in collaboration with a leading diagnostics platform provider. Receipt of clearance for the Colli-Pee device for these indications would be in addition to the existing Research-use Only product and is expected to expand access to testing and further strengthen OTI's leadership position in novel collection devices and chemistries.