CORRECTION - OraQuick® HIV Self-Test Now Approved for Use in Adolescents
Rhea-AI Summary
OraSure Technologies (NASDAQ: OSUR) announced FDA approval for expanding the age range of its OraQuick® HIV Self-Test to include individuals 14 years and older, down from the previous minimum age of 17. This expansion addresses a critical need, as CDC data shows that 19% of new HIV diagnoses in the US occur among those aged 13-24, with only 6% of high school students ever being tested for HIV. Almost half of young people with HIV are unaware of their status.
The OraQuick® HIV Self-Test has been available to US consumers since 2012. The test includes educational materials and care information to help users make informed decisions regardless of results. This approval aims to increase HIV testing accessibility among adolescents and support early connection to care for those testing positive.
Positive
- FDA approval for expanded age range (14+ years) increases market potential
- Addresses untapped market segment with 19% of new HIV diagnoses in 13-24 age group
- Product targets underserved demographic with only 6% of high school students tested
Negative
- None.
Insights
The FDA's expanded approval for the OraQuick® HIV Self-Test to include adolescents aged 14 and older represents a significant market expansion opportunity. With
The addressable market potential is particularly compelling given that nearly half of HIV-positive young people are unaware of their status. This regulatory change could drive increased test adoption in schools, youth clinics and other adolescent healthcare settings. Considering OraQuick's established market presence since 2012 and its first-mover advantage in this expanded demographic, this positions OraSure to potentially capture significant market share in this underserved segment.
The timing aligns with increased focus on youth healthcare accessibility and could benefit from potential public health initiatives targeting adolescent testing programs. The inclusion of educational materials and care linkage information in the packaging adds value proposition and could help drive adoption among healthcare providers and institutions serving younger populations.
This regulatory win opens up a important demographic that could meaningfully impact OraSure's revenue growth trajectory. The expansion to ages 14-16 represents approximately 12 million additional potential users in the U.S. market alone. The current low testing rates among adolescents, combined with high undiagnosed rates, suggests significant growth potential for test kit sales.
The approval's value extends beyond immediate sales potential - it strengthens OraSure's competitive positioning in the HIV diagnostics market and could lead to similar approvals in international markets where adolescent HIV testing access remains The company's established distribution channels and decade-long market presence provide infrastructure advantages for rapid market penetration in this expanded demographic.
While initial uptake may be gradual due to awareness building and healthcare provider education needs, the long-term market opportunity is substantial. This could translate into steady revenue growth as testing programs adapt to include younger populations and public health initiatives increasingly focus on early detection in adolescents.
BETHLEHEM, Pa., Jan. 07, 2025 (GLOBE NEWSWIRE) -- In a release issued under the same headline on Tuesday, January 7th by OraSure Technologies, Inc. (NASDAQ: OSUR), please note that the first sentence of the release (read "OraQuick® HIV Self-Test that will increase access to HIV testing for adolescents.") is incomplete. The corrected release follows:
OraSure Technologies, Inc. (“OTI”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced that The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has approved a labeling change to the OraQuick® HIV Self-Test that will increase access to HIV testing for adolescents. The change expands the approved age range to include individuals 14 years of age and older for the OraQuick® HIV Self-Test. Previously the test was approved for use in those 17 and older.
According to the most recent data available from the Centers for Disease Control & Prevention, it is estimated that 19 percent of new HIV diagnoses in the United States were among young people aged 13 to 24, and only 6 percent of high school students have ever been tested for HIV. Almost half of young people with HIV do not know that they have it.
“Increasing access to different testing options is critical to ending the HIV epidemic for all people, and early connection to care is essential for adolescents who test positive for HIV,” said Carrie Eglinton Manner, President and CEO of OraSure Technologies. “We are pleased that our OraQuick® HIV Self-Test can now be used within this younger population who needs it, and we are proud of the work we have done to promote HIV testing, help people know their HIV status, and stop the stigma of infection. This approval will allow us to expand access to help those who need it.”
The OraQuick® HIV Self-Test has been available direct to consumers in the U.S. since 2012. Since its launch, OraSure has been committed to providing consumers with access to critical information and connection to care. The packaging contains robust educational material and linkage to care information, giving individuals information that they can use to make informed decisions, regardless of the test result.
About OraSure Technologies, Inc.
OraSure Technologies, Inc. (“OraSure”) transforms health through actionable insight and powers the shift that connects people to healthcare wherever they are. OraSure improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. OraSure, together with its wholly-owned subsidiaries, DNA Genotek Inc. and Sherlock Biosciences, Inc., 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. OraSure’s 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 to consumers. For more information on OraSure Technologies, please visit www.orasure.com.
Forward-Looking Statement
This press release contains certain forward-looking statements addressing expectations, prospects, estimates and other matters that are dependent upon future events or developments. These statements may be identified by words such as "expect," "anticipate," "intend," "plan," "believe," "will," "should," "could," "would," "project," "continue," "likely," and similar expressions. Forward-looking statements are not guarantees of future performance or results. 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: our ability to satisfy customer demand; ability to market and sell products, whether through our internal, direct sales force or third parties; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; ability to comply with applicable regulatory requirements; ability to meet increased demand for OraSure’s products; competition from new or better technology or lower cost products; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; ability to obtain and maintain new or existing product distribution channels; impact of negative economic conditions; ability to maintain sustained profitability; changes in international, federal or state laws and regulations; equipment failures and ability to obtain needed raw materials and components. 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, 2023, 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 Technologies undertakes no duty to update these statements.
| Investor Contact: | Media Contact: |
| Jason Plagman | Amy Koch |
| Vice President, Investor Relations | Director, Corporate Communications |
| investorinfo@orasure.com | media@orasure.com |
FAQ
What is the new age requirement for OraQuick HIV Self-Test (OSUR) as of January 2024?
What percentage of new HIV diagnoses are among young people according to CDC data cited by OSUR?
How long has the OraQuick HIV Self-Test (OSUR) been available to US consumers?
What percentage of high school students have been tested for HIV according to OSUR's announcement?
