OraSure to Launch OraQuick™ HIV Self-Test in Canada
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.
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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.
Details
News Market Reaction – OSUR
On Feb 10, the day this news came out, OSUR closed 0.35% below the previous close.
Data tracked by StockTitan Argus for the Feb 10 session.
Key Figures
- New HIV diagnoses 2024
- 1,826 cases
- Public Health Agency of Canada (excluding Québec)
- National HIV diagnosis rate
- 5.7 per 100,000 people
- Canada 2024 (excluding Québec)
- Manitoba HIV rate
- 19.5 per 100,000 people
- Highest provincial HIV rate in Canada in 2024
- Saskatchewan HIV rate
- 18.6 per 100,000 people
- Second-highest provincial HIV rate in Canada in 2024
- Time to result
- 20 minutes
- OraQuick HIV Self-Test result time from oral swab
- Undiagnosed HIV population
- 7,000+ people
- Estimated people living with HIV undiagnosed in Canada
- Countries available
- 60+ countries
- Global availability of OraQuick HIV Self-Test
- U.S. DTC availability since
- 2012
- U.S. direct-to-consumer launch year for OraQuick HIV Self-Test
Historical Context
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Announcement of Q4 2025 results date and associated investor conference call.
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Altai Capital nominates two directors, citing share performance and governance concerns.
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FDA submissions for CT/NG molecular self-test and Colli-Pee urine collection device.
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Company statement on Altai’s intent to nominate directors and recap of cash and buyback.
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Altai Capital announces intention to nominate director candidates to the board.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
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. How Rhea-AI works. 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.
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