---
schema_version: "secwatch.filing_event.v1"
accession: "0001116463-26-000002"
form_type: "8-K"
ticker: "OSUR"
cik: "0001116463"
company_name: "ORASURE TECHNOLOGIES INC"
filed_at: "2026-01-05T23:59:59+00:00"
generated_at: "2026-05-16T11:37:52.184732+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# OraSure submits two FDA applications for rapid CT/NG self-test and at-home urine collection device

## Summary
- Submitted two FDA 510(k) applications: one for a rapid molecular self-test for Chlamydia and Gonorrhea (CT/NG) and one for the Colli-Pee at-home urine collection device for STI indications.
- Rapid CT/NG self-test is designed to deliver results in approximately 30 minutes in a disposable, over-the-counter format.
- Colli-Pee device is intended for at-home urine collection, including for multiple STI indications.
- No timeline for FDA clearance; approval would open new OTC market for OraSure in sexual health diagnostics.

## SEC filing metadata
- accession: 0001116463-26-000002
- form_type: 8-K
- ticker: OSUR
- cik: 0001116463
- company_name: ORASURE TECHNOLOGIES INC
- filed_at: 2026-01-05T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1116463/000111646326000002/0001116463-26-000002-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1116463/000111646326000002/osur-20260105.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001116463-26-000002
- JSON: https://secwatch.observer/filing/0001116463-26-000002.json
- Plain text: https://secwatch.observer/filing/0001116463-26-000002.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.