OraSure Submits FDA Applications for Rapid Self-Test Devices with $1.5B Market Potential
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
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Source: Globenewswire
- Innovation Milestone: OraSure submitted FDA applications for rapid self-tests for Chlamydia trachomatis and Neisseria gonorrhoeae at the end of 2025, marking significant progress on its innovation roadmap and potentially enhancing its leadership in the rapid diagnostics market.
- Market Opportunity: The rapid self-test, built on the Sherlock molecular diagnostics platform, is designed to deliver results in approximately 30 minutes, targeting a total addressable market exceeding $1.5 billion for CT/NG testing, indicating substantial market expansion potential for OraSure in the rapid testing sector.
- Enhanced Convenience: The new device utilizes a self-collected swab and allows results to be read directly without an electrical connection, which enhances user flexibility and convenience, aligning with patient preferences for private and convenient testing, thereby potentially increasing market acceptance.
- Collaborative Development: OraSure also submitted an application for the Colli-Pee™ at-home urine collection device, aimed at expanding access to testing and developed in collaboration with a leading diagnostics platform provider, further solidifying its leadership position in novel collection devices and chemistries.
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About OSUR
OraSure Technologies, Inc. transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. The Company improves the access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. The Company, together with its wholly owned subsidiaries, DNA Genotek Inc. and Sherlock Biosciences, Inc., is engaged in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. Its portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct consumers. Its products and services include OraQuick ADVANCE Rapid HIV1/2 Antibody Test, OraQuick HIV Self-Test, and Diagnostics Direct Syphilis Health Check.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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