FDA Clears Home Urine Collection Kit for STI Testing - Summary - MDSpire
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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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Objective:

To inform about the FDA clearance of the Colli-Pee Dx Urine Collection Kit for at-home STI testing.

Approach:
    Key Findings:
    • The kit is authorized for use with Roche molecular assays on cobas 5800, 6800, and 8800 systems.
    • It allows for mail-in specimen collection and supports high-volume laboratory testing.
    • The kit collects a measured first-void urine specimen, crucial for accurate STI detection.
    Interpretation:

    The clearance reflects progress in providing user-friendly tests for decentralized settings.

    Conclusion:

    The Colli-Pee Dx Urine Collection Kit will be distributed through DNA Genotek, enhancing STI testing accessibility.

    Sources:

Original Source(s)

FDA Clears Home Urine Collection Kit for STI Testing

  • by Kathryn Wighton

  • June 11, 2026

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