OraSure Technologies has received U.S. FDA clearance for its Colli-Pee Dx Urine Collection Kit for use with Roche molecular tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium.

The clearance enables at-home self-collection of first-void urine samples for male and female patients. The samples can then be processed on Roche’s cobas 5800, 6800 and 8800 molecular diagnostic systems.

This is relevant because STI testing still faces access, privacy and convenience barriers. Patients may delay testing due to stigma, mobility limitations, lack of nearby clinics or discomfort with in-person sample collection. A validated at-home collection workflow could help increase testing participation and support earlier diagnosis.

The Colli-Pee Dx kit uses stabilization technology to maintain urine sample integrity at ambient temperatures. This is important for mail-in testing models, where sample quality and transport conditions can affect laboratory reliability.

The development also reflects the increasing convergence between home diagnostics and high-throughput laboratory platforms. Healthcare providers can prescribe the collection kit, while laboratories can process self-collected samples through existing Roche cobas automated systems.

For public health programmes, the clearance could support more scalable STI screening models, particularly for underserved or hard-to-reach populations. The broader opportunity is in decentralised diagnostics that improve access without moving testing entirely away from regulated laboratory infrastructure.