OraSure to Launch OraQuick™ HIV Self-Test in Canada
Rhea-AI Summary
OraSure (NASDAQ: OSUR) received a Health Canada license for the OraQuick HIV Self-Test, Canada’s first oral HIV self-test, on Feb 10, 2026. The rapid antibody oral test detects HIV-1 and HIV-2 and delivers results in as little as 20 minutes.
St. Michael’s Hospital (Unity Health Toronto) will serve as exclusive Canadian distributor to provide national access; the test has been available direct-to-consumer in the U.S. since 2012 and is sold in 60+ countries.
Positive
- Health Canada license enables Canadian sales (Feb 10, 2026)
- Oral test detects HIV-1 and HIV-2 in about 20 minutes
- Exclusive Canadian distribution via St. Michael’s Hospital (national access)
- Product already sold in 60+ countries; U.S. DTC availability since 2012
Negative
- None.
News Market Reaction
On the day this news was published, OSUR declined 0.35%, reflecting a mild negative market reaction. Argus tracked a peak move of +3.1% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $710K from the company's valuation, bringing the market cap to $202M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
OSUR’s pre-news gain of 4.06% contrasts with mixed peers: STSS up 7.36%, STXS up 4.95%, while INFU and NYXH are down slightly and UTMD is nearly flat, pointing to stock-specific drivers rather than a broad sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 09 | Earnings call scheduling | Neutral | +4.1% | Announcement of Q4 2025 results date and associated investor conference call. |
| Jan 15 | Activist nominations | Neutral | +1.7% | Altai Capital nominates two directors, citing share performance and governance concerns. |
| Jan 05 | Regulatory submission | Positive | +3.8% | FDA submissions for CT/NG molecular self-test and Colli-Pee urine collection device. |
| Dec 17 | Activist response | Neutral | +1.6% | Company statement on Altai’s intent to nominate directors and recap of cash and buyback. |
| Dec 17 | Activist intent | Neutral | +1.6% | Altai Capital announces intention to nominate director candidates to the board. |
Recent company and governance announcements have tended to see modest positive price reactions, including product pipeline updates and activist-related developments.
Over the past few months, OraSure has combined product innovation with governance developments. A Jan 5, 2026 update on CT/NG self-test and Colli-Pee™ FDA submissions coincided with a positive reaction. Activist investor Altai Capital’s stake and board nomination efforts around Dec 17, 2025 also saw mild gains. An earnings call scheduling notice on Feb 9, 2026 similarly aligned with a small uptick. Against this backdrop, Health Canada’s licensing of the OraQuick HIV Self-Test extends OraSure’s self-testing footprint into Canada.
Market Pulse Summary
This announcement extends OraSure’s HIV self-testing reach, with Health Canada licensing the OraQuick HIV Self-Test as the country’s first oral HIV self-test. The product targets a documented burden of 1,826 new diagnoses annually and more than 7,000 undiagnosed individuals. In context of prior FDA submissions for other self-tests and ongoing activist scrutiny, investors may watch adoption levels, reimbursement, and how new markets contribute to reversing earlier revenue declines.
Key Terms
point-of-care medical
antibody medical
hiv-1 medical
hiv-2 medical
oral fluid test medical
direct-to-consumer technical
AI-generated analysis. Not financial advice.
BETHLEHEM, Pa., Feb. 10, 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 its OraQuick™ HIV Self-Test has received a license from Health Canada for use in Canada.
The OraQuick™ HIV Self-Test is a point-of-care rapid antibody test. It is Canada’s first oral HIV self-test and detects antibodies for both HIV-1 and HIV-2, enabling individuals to find out their HIV status with a simple oral swab in as little as 20 minutes. The simplicity of the product makes it ideal for testing in a range of locations, including in the privacy of one’s home, at the pharmacy, or at community-based testing events.
Data from the Public Health Agency of Canada show there were 1,826 new HIV diagnoses in 2024 (not including Québec), for a national rate of 5.7 per 100,000 people. Some provinces continue to experience far higher rates. Manitoba and Saskatchewan reported rates three to four times the national average. In 2024, Manitoba recorded the highest HIV rate in Canada at 19.5 per 100,000 people, followed closely by Saskatchewan at 18.6 per 100,000.
“Expanding access to HIV testing options is a critical component in the global effort to end the HIV epidemic,” said Carrie Eglinton Manner, President and CEO of OraSure. “Early diagnosis and linkage to care remain essential for improving health outcomes. We are pleased that Health Canada has issued a license for the OraQuick HIV Self-Test, enabling individuals across Canada to know their HIV status at home in a private, convenient way using a simple oral fluid test. This milestone allows us to continue our commitment to advancing public health, reducing stigma, and ensuring that more people have access to the tools they need.”
The OraQuick HIV Self-Test has been available for direct-to-consumer purchase in the United States since 2012 and is now available in more than 60 countries worldwide. OraSure is committed to providing consumers with access to critical health information and connection to care. The packaging contains robust educational material and linkage to care information that individuals can use to make informed decisions, regardless of the test result.
“This oral fluids test presents the next major step forward in helping to democratize HIV self-testing and reach the more than 7,000+ people who are still undiagnosed in Canada - people who are living with HIV but don’t know their status, and are not benefitting from life-saving treatments,” said Dr. Sean B. Rourke, director of REACH Nexus housed at MAP Centre for Urban Health Solutions at St. Michael’s Hospital (Unity Health Toronto). “This gives people the freedom to test when and where it works best for them, right in their own community.”
St. Michael’s Hospital (Unity Health Toronto) is the exclusive distributor of the OraQuick HIV Self-Test in Canada. Through this role, St. Michael’s will ensure national access to the test, supporting timely, reliable, and equitable access to testing across healthcare and community settings nationwide. To order OraQuick tests or learn more contact reachnexus@unityhealth.to.
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 |
REACH Nexus Media Contact:
Andrew Russell
Senior Communications Specialist, REACH Nexus
andrew.russell@unityhealth.to
Phone: 416-268-7642
OraQuick HIV Self-Test Canada Distribution Contact:
Sean B. Rourke, PhD; Scientist, MAP Centre for Urban Solutions
St Michael’s Hospital (Unity Health Toronto)
30 Bond Street, Toronto, ON M5B 1W8
reachnexus@unityhealth.to
Forward Looking Statements
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, 2024, 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.
FAQ
What did OraSure (OSUR) announce on Feb 10, 2026 about Canada?
How quickly does the OraQuick HIV Self-Test (OSUR) provide results in Canada?
Who will distribute OraQuick HIV Self-Test in Canada and how will access work?
What is the public-health context for OraQuick’s Canadian launch (OSUR)?
Has the OraQuick HIV Self-Test been used elsewhere before launching in Canada (OSUR)?
