OraSure submits two FDA applications for rapid CT/NG self-test and at-home urine collection device

ORASURE TECHNOLOGIES INC

Submitted two FDA 510(k) applications: one for a rapid molecular self-test for Chlamydia and Gonorrhea (CT/NG) and one for the Colli-Pee at-home urine collection device for STI indications.
Rapid CT/NG self-test is designed to deliver results in approximately 30 minutes in a disposable, over-the-counter format.
Colli-Pee device is intended for at-home urine collection, including for multiple STI indications.
No timeline for FDA clearance; approval would open new OTC market for OraSure in sexual health diagnostics.

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