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:

• OraSure Technologies, Inc
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