FDA Clears Home Urine Collection Kit for STI Testing - Takeaways - MDSpire

FDA Clears Home Urine Collection Kit for STI Testing

The clearance enables a validated mail-in workflow for self-collected urine specimens processed on Roche cobas systems.

  • By

  • Kathryn Wighton

  • June 11, 2026

  • 2 min

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  • 1

    The FDA has cleared the Colli-Pee Dx Urine Collection Kit for at-home STI testing using Roche assays.

  • 2

    The kit allows collection of first-void urine specimens for detecting Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma.

  • 3

    It incorporates NucleoPrecision Technology to stabilize DNA and RNA in urine specimens at ambient temperatures.

  • 4

    Health care providers can prescribe the kit, enabling direct mail-in specimen collection for laboratory testing.

  • 5

    OraSure Technologies aims to enhance user-friendly testing options in decentralized settings with this innovation.

Original Source(s)

FDA Clears Home Urine Collection Kit for STI Testing

  • by Kathryn Wighton

  • June 11, 2026

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