OraSure Seeks FDA Nod for Rapid At-Home Chlamydia & Gonorrhea Test

BETHLEHEM, PA – January 05, 2026 – OraSure Technologies, a leader in home diagnostics, has taken a significant step toward revolutionizing personal healthcare by submitting two new products to the U.S. Food and Drug Administration (FDA) for review. The submissions, filed at the close of 2025, include a rapid molecular self-test for chlamydia and gonorrhea (CT/NG) and a novel at-home urine collection device, signaling a major push to shift sensitive diagnostic testing from the clinic to the privacy of one's home.

If cleared, these products could dramatically alter the landscape of sexual health management, offering consumers a faster, more private, and more convenient way to test for two of the most common sexually transmitted infections (STIs). The move aligns with the company’s broader goal of making diagnostics more accessible.

“These submission milestones reflect meaningful progress on our innovation roadmap and bring us closer to realizing our vision of decentralizing diagnostics and connecting people to care that is more accessible, convenient, private, and personalized,” said Carrie Eglinton Manner, President and CEO of OraSure, in a statement.

Addressing a Critical Public Health Need

The timing of OraSure's submissions is critical, as the United States continues to grapple with high rates of STIs. According to the most recent data from the Centers for Disease Control and Prevention (CDC), more than 2.4 million cases of chlamydia, gonorrhea, and syphilis were reported in 2023. Chlamydia remains the most common nationally notifiable STI, with over 1.6 million reported cases, while gonorrhea accounted for more than 600,000 cases. Adolescents and young adults between the ages of 15 and 24 are disproportionately affected, representing nearly half of all new diagnoses.

A significant barrier to curbing these numbers is the reluctance of many individuals to seek testing. Factors such as the stigma surrounding STIs, concerns about privacy, and the inconvenience of scheduling appointments and traveling to a clinic contribute to low screening rates. The traditional testing process, which often involves a wait of several days for lab results, can also lead to delays in treatment and continued transmission.

At-home testing solutions are poised to directly address these challenges. By providing a discreet option, they can empower individuals who might otherwise avoid testing to take control of their sexual health. The potential for rapid results, in particular, could dramatically shorten the window between detection and treatment, a crucial factor in public health efforts to reduce infection rates.

A New Frontier in Diagnostic Technology

At the heart of OraSure's strategy is cutting-edge technology designed for consumer use without sacrificing accuracy. The rapid self-test for CT/NG is built on the Sherlock molecular diagnostics platform, which the company acquired in 2024. This platform utilizes a combination of isothermal amplification and CRISPR-based technology, enabling what OraSure describes as lab-quality results in a simple, disposable format.

The test is designed to be performed entirely at home using a self-collected swab. In approximately 30 minutes, the result is displayed directly on the handheld device, which notably requires no batteries or electrical connection. This completely self-contained, over-the-counter format represents a significant leap from current at-home options, which typically require users to mail a sample to a centralized lab for analysis.

Complementing the rapid test is the second submission: the Colli-Pee™ at-home urine collection device. This device is engineered to simplify the collection of a high-quality urine sample, specifically the "first-void" portion, which research shows contains higher concentrations of STI-related DNA and can lead to more accurate detection. Studies have demonstrated that the Colli-Pee™ is easy to use and well-received by users, with one study showing nearly 88% of participants found it easy or very easy to use. The submission covers multiple STI indications and, if cleared, would expand its use beyond its current "Research-use Only" status, further strengthening options for private and convenient sample collection.

Tapping into a Multi-Billion Dollar Market

Beyond the public health implications, OraSure's move is a strategic play for a substantial market. The company estimates the total addressable market for CT/NG testing at over $1.5 billion, a figure supported by market research reports projecting a global market value of nearly $2.7 billion by 2028. Currently, this market is overwhelmingly dominated by large diagnostic companies like Abbott, Roche, and Hologic, whose systems are used in centralized laboratories.

By introducing a rapid, over-the-counter molecular test, OraSure is not just competing with existing players but attempting to create and capture a new segment of the market. This strategy targets the unmet needs of consumers who prioritize speed and privacy over a traditional clinical setting. While companies like Everlywell offer mail-in lab kits and Visby Medical has a rapid, instrument-based test, OraSure’s proposed product aims to combine the best of both worlds: the convenience of a fully at-home process with the speed of a rapid molecular result, all in a disposable format.

The Path Forward: Navigating FDA Review and Market Adoption

The fate of these innovative products now rests with the FDA. The submissions for "clearance" suggest OraSure is pursuing a 510(k) pathway, which requires the company to demonstrate that its devices are "substantially equivalent" to a legally marketed predicate device. This process typically takes between three and twelve months, though it can be extended if the agency requests additional information. A key hurdle will be providing robust data that proves the accuracy and reliability of the tests when used by ordinary consumers without clinical supervision.

Should the products receive FDA clearance, their success will depend on several factors. Consumer trust in the accuracy of at-home results will be paramount, a challenge OraSure hopes to meet with its "lab-like accuracy" messaging. Cost will also be a major consideration. While pricing has not been announced, affordability will be key to widespread adoption.

Furthermore, reimbursement pathways will be crucial. The Affordable Care Act (ACA) mandates coverage for certain STI screenings, and some states have already passed legislation requiring insurance plans to cover at-home test kits. Securing broad insurance coverage and inclusion in public health screening programs will be essential for ensuring equitable access and making these tests a viable option for a large portion of the population. The FDA's decision in the coming months will be a critical determinant in whether this new era of private, rapid STI testing becomes a reality for American consumers.