FDA Clears Home Urine Collection for Chlamydia and Gonorrhea Testing

Originally surfaced June 13, 2026, drawing on OraSure's June 11 FDA-clearance announcement and related SEC filing.

The Food and Drug Administration has cleared a home urine collection device that lets patients collect their own specimens for sexually transmitted infection laboratory testing in a private setting, then send the sample to a certified laboratory for processing.

The product is DNA Genotek's Colli-Pee Dx Urine Collection Kit, from OraSure Technologies. OraSure announced on June 11, 2026 that the kit is cleared for use with Roche tests for four pathogens: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Those tests run on Roche's cobas 5800, 6800, and 8800 molecular diagnostic systems.

The collection method is first-void urine, meaning the first portion of urine passed during a bathroom visit. OraSure says the kit uses NucleoPrecision Technology, a proprietary chemistry for DNA and RNA stabilization, and is designed to maintain urine sample integrity at ambient temperatures during transport.

This is not a rapid over-the-counter self-test. The FDA action is about specimen collection for lab testing. Patients still send specimens to a laboratory, and the analytical step happens on Roche's clinical molecular systems. Results come through the laboratory's reporting channel, not through an instant device readout.

Why the clearance matters

The practical change is that specimen collection can move out of the clinic while keeping the laboratory testing step intact. OraSure framed the cleared workflow as a scalable mail-in model for laboratories and health systems that want high-volume molecular STI testing without requiring in-clinic urine collection.

That matters because the clinic visit itself is a barrier for some people: scheduling, transportation, privacy concerns, cost, stigma, or geography can all delay testing. A home-collection workflow does not solve every access problem, but it removes one friction point while preserving lab-based molecular testing.

It also shows the distinction between testing access and test interpretation. Home collection can make it easier to get a specimen into the lab. It does not decide who should test, how often testing is appropriate, what a result means, or what follow-up care is needed.

The LTS testing context

LabTestSuperstore already offers self-pay STI testing options, including a chlamydia and gonorrhea test, a Basic STD Panel, and an Expanded STD Panel. Those pages describe current ordering options through participating labs; they are not the same thing as OraSure's newly cleared home-collection kit.

The connection is broader: laboratory medicine is moving toward workflows that separate specimen collection from the traditional office visit. For STI testing, that can make access feel less intimidating without turning the test into a casual at-home gadget.

What not to overread

The clearance does not mean every STI can be handled through urine collection. STI testing depends on the organism, exposure site, symptoms, test type, and clinical context. It also does not replace care after a positive result. LabTestSuperstore provides testing access and educational context, not diagnosis or treatment.

The January 2026 OraSure release also matters for framing. OraSure said it submitted applications at the end of 2025 for both a rapid CT/NG molecular self-test and the Colli-Pee urine collection device. This June clearance is for the urine collection kit used with Roche laboratory systems, not for a consumer rapid CT/NG self-test.

This article is editorial commentary and is not medical advice. It has not been reviewed by a physician and should not be used to make decisions about testing, treatment, or sexual-health care.