OraSure Technologies, Inc. Announces FDA Clearance that Expands Patient‑Friendly Access to Testing for Sexually Transmitted Infections
Rhea-AI Summary
OraSure Technologies (NASDAQ:OSUR) received FDA clearance for its Colli-Pee™•Dx Urine Collection Kit, used with Roche cobas® 5800, 6800, and 8800 systems to test for CT, NG, TV, and MG.
The kit enables at-home, first-void urine self-collection at ambient temperatures, supporting scalable, mail-in, decentralized STI testing for broader patient access.
Positive
- FDA clearance for Colli-Pee™•Dx kit with Roche cobas® 5800/6800/8800 systems
- Supports at-home, first-void urine self-collection for CT, NG, TV, and MG testing
- Stabilization technology maintains urine sample integrity at ambient temperatures
- Enables high-volume, mail-in molecular STI testing for labs and health systems
- Expands access to STI testing for mobility- and geography-constrained populations
Negative
- None.
News Market Reaction – OSUR
On the day this news was published, OSUR gained 3.97%, reflecting a moderate positive market reaction. This price movement added approximately $11M to the company's valuation, bringing the market cap to $277.46M at that time.
Data tracked by StockTitan Argus on the day of publication.
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 06 | Q1 2026 earnings | Negative | +4.3% | Reported revenue declines and operating losses but guided Q2 revenue. |
| Apr 22 | Earnings date notice | Neutral | -2.2% | Announced timing and access details for upcoming Q1 2026 call. |
| Apr 16 | Board appointment | Positive | -1.6% | Added independent director and declassification proposal with Altai agreement. |
| Mar 17 | Operational update | Positive | -2.7% | Outlined transformation progress, FDA submissions, buyback and cost cuts. |
| Mar 17 | Activist letter | Negative | -4.8% | Altai criticized underperformance and urged strategic review and changes. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent history shows mixed reactions: one weak quarter saw a positive move, while governance and strategic updates often coincided with modest declines, suggesting inconsistent pricing of corporate news.
Over the last few months, OraSure’s narrative has centered on operational turnaround and governance changes. In March 2026, the company highlighted transformation efforts, including two FDA submissions and a $40M buyback, yet shares fell after that and after Altai’s activist letter. Board changes and cooperation with Altai in April 2026 also saw a mild decline. By May 6, 2026, Q1 earnings with lower revenues and a GAAP loss nevertheless produced a positive move, underscoring uneven market responses to fundamentals and strategy updates versus today’s FDA-focused news.
Key Terms
fda clearance regulatory
molecular diagnostic systems medical
first-void urine medical
dna and rna medical
chlamydia trachomatis medical
neisseria gonorrhoeae medical
trichomonas vaginalis medical
mycoplasma genitalium medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
The clearance combines OraSure’s Colli-Pee™•Dx Urine Collection Kit for at-home sample collection with Roche’s cobas® molecular lab testing equipment
BETHLEHEM, Pa., June 11, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (“OraSure”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions today announced U.S. Food and Drug Administration (FDA) clearance of its Colli-Pee™•Dx Urine Collection Kit from its subsidiary DNA Genotek Inc., for use with Roche’s tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) and run on Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems. The FDA-cleared collection kit supports at-home self-collection of first-void urine, enabling convenient sample collection at-home or in any private setting for both male and female patients.
This clearance marks a significant advancement in patient-centric diagnostics, combining OraSure’s Colli-Pee™•Dx Urine Collection Kit, which includes NucleoPrecision™ Technology, a proprietary chemistry for DNA and RNA stabilization, with Roche’s cobas® high-throughput molecular testing capabilities. The Colli-Pee™•Dx Urine Collection Kit uses innovative stabilization technology to make STI laboratory testing easier by allowing reliable, private at-home urine collection and maintaining urine sample integrity at ambient temperatures. It expands access for individuals constrained by mobility, geography, or other barriers; improves patient convenience; and makes population-level screening programs feasible for broader, previously underserved populations. Healthcare providers can now prescribe, and laboratories can now receive, self-collected urine specimens directly from patients’ homes and process them seamlessly and at scale using Roche’s cobas® automated laboratory platforms.
The Colli-Pee™•Dx Urine Collection Kit is designed to collect volumetric, first-void urine, ensuring optimal sample-to-preservative-ratio, a critical factor for STI detection, while offering a simple, non-invasive experience that prioritizes patient convenience and privacy.
“This clearance connects people to care that is more accessible, convenient, private, and personalized. It showcases what’s possible when you design solutions around real-life patient behavior,” said Carrie Eglinton Manner, President and Chief Executive Officer of OraSure. “We are committed to delivering user-friendly tests and collection devices that can be conveniently used in decentralized settings, and this clearance reflects meaningful progress on our innovation roadmap.”
Enabling Scalable, Decentralized Testing
With FDA clearance, laboratories and health systems can now deploy a fully validated mail-in workflow that supports high-volume molecular STI testing without invasive sample collection methods. The collaboration enables the convenience of at-home urine collection, improves reach to populations in need, and supports public health initiatives focused on early detection and treatment of STIs.
The Colli-Pee™•Dx Urine Collection Kit will be sold by OraSure subsidiary DNA Genotek.
About OraSure Technologies
OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OTI improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OTI’s portfolio of products is sold globally to clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information, please visit www.orasure.com.
| Investor Contact: | Media Contact: |
| Jason Plagman | Amy Koch |
| Vice President, Investor Relations | Director, Corporate Communications |
| investorinfo@orasure.com | media@orasure.com |
Forward Looking Statement
This press release contains certain “forward-looking statements.” Forward-looking statements are based on current expectations of future events and are not guarantees of future performance or results. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from expectations and projections. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: uncertainty of commercial success; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; unexpected safety, quality or manufacturing issues; government regulation and unexpected regulatory actions or delays; ability to comply with applicable regulatory requirements; uncertainty relating to patent protection and potential patent infringement claims; impact of competitors, competing products and technology changes and patents obtained by competitors; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; impact of negative economic conditions; changes in behavior and spending patterns of purchasers; product efficacy or safety concerns resulting in product recalls or regulatory action; and changes to applicable laws and regulations. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2025, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure undertakes no duty to update these statements.
