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OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review

OraSure Technologies, Inc. (OSUR) | January 5, 2026

By Mia Evans

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OraSure, a leader in diagnostic innovation, submitted groundbreaking applications to the FDA for the clearance of a rapid self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) alongside an innovative at-home urine collection device, signaling a strategic move towards decentralized diagnostics and personalized healthcare.

These submissions mark a pivotal step in OraSure's broader innovation roadmap, aligning with the company's mission to provide more accessible, convenient, and private healthcare solutions to individuals, disrupting traditional diagnostic practices and expanding the landscape of healthcare accessibility.

By introducing a rapid molecular self-test for CT/NG that delivers results in just 30 minutes, OraSure enhances convenience and accessibility for consumers seeking quick and reliable diagnostic solutions. Simultaneously, the Colli-Pee™ urine collection device caters to patient preferences for private and convenient testing, bolstering OraSure's position in the market and capturing a broader customer base.

Innovative Self-Test

OraSure's introduction of a rapid molecular self-test for CT/NG represents a significant leap in diagnostic technology, offering consumers swift and convenient results within half an hour, a stark improvement from conventional testing methods. This advancement underscores the company's commitment to enhancing user experience and healthcare accessibility through cutting-edge solutions.

Market Expansion Potential

With a sizable addressable market exceeding $1.5 billion for CT/NG tests, OraSure's self-testing solution holds substantial growth prospects, positioning the company to capitalize on the increasing demand for rapid and accurate diagnostic tools. This strategic move not only augments OraSure's revenue potential but also solidifies its competitive edge in the diagnostics sector.

At-Home Collection Device

The introduction of the Colli-Pee™ urine collection device aligns seamlessly with consumer preferences for at-home, private diagnostic testing, addressing the growing need for accessible and discreet healthcare solutions. By catering to patient convenience and comfort, OraSure expands its reach and enhances its brand appeal, driving adoption rates and fostering customer loyalty.

  • OraSure's recent submissions to the FDA epitomize the company's unwavering dedication to revolutionizing healthcare accessibility and personalization through state-of-the-art diagnostics, positioning itself as an industry leader in innovation and user-centric care. The prospective clearance of the CT/NG self-test and the Colli-Pee™ device not only signifies a groundbreaking advancement in diagnostic technologies but also signifies a transformative shift towards decentralized, patient-centric healthcare models, reshaping the industry landscape and underscoring OraSure's commitment to driving positive health outcomes.

OraSure's strategic move to submit the CT/NG molecular self-test and the Colli-Pee™ urine collection device for FDA review marks a pivotal shift towards decentralized diagnostics and personalized care, reflecting the company's proactive stance in advancing healthcare accessibility and fostering innovation within the healthcare sector.