ORASURE TECHNOLOGIES INC 8-K

What Happened
OraSure Technologies, Inc. announced on January 5, 2026 that it submitted two separate applications to the U.S. Food and Drug Administration (FDA): one seeking clearance for its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG), and one for its Colli-Pee™ at-home urine collection device, including use for sexually transmitted infections (STIs). The company says the rapid molecular self-test is disposable, intended for over‑the‑counter (OTC) use, and provides results in approximately 30 minutes. The company attached a press release dated January 5, 2026 to the filing.

Key Details

• Date filed: January 5, 2026 (8-K reporting Regulation FD disclosure and related events).
• Product 1: Rapid molecular CT/NG self-test — disposable, OTC‑intended, ~30‑minute results.
• Product 2: Colli‑Pee at‑home urine collection device — designed for at‑home collection, including multiple STI indications.
• Filing included a press release (Exhibit 99.1) announcing the FDA submissions.

Why It Matters
This filing signals OraSure is seeking FDA clearance to expand into OTC rapid molecular testing for common STIs and to support at‑home specimen collection. For investors, FDA submissions are an important regulatory milestone but do not guarantee clearance, commercialization, or revenue — approvals and timelines remain uncertain. If cleared, these products could expand OraSure’s consumer-facing diagnostics portfolio and address demand for convenient at‑home STI testing, potentially impacting future product adoption and revenue growth.