CORRECTION - OraQuick® HIV Self-Test Now Approved for Use in Adolescents
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.
OraSure Technologies (NASDAQ: OSUR) ha annunciato l'approvazione della FDA per ampliare la fascia di età del suo OraQuick® HIV Self-Test per includere individui a partire da 14 anni, rispetto al precedente limite minimo di 17. Questa espansione risponde a un bisogno critico, poiché i dati del CDC mostrano che il 19% delle nuove diagnosi di HIV negli Stati Uniti riguarda persone di età compresa tra 13 e 24 anni, con solo il 6% degli studenti delle scuole superiori che è stato testato per l'HIV. Quasi la metà dei giovani con HIV non è a conoscenza del proprio stato.
Il test OraQuick® HIV Self-Test è disponibile per i consumatori statunitensi dal 2012. Il test include materiali educativi e informazioni per la cura per aiutare gli utenti a prendere decisioni informate indipendentemente dai risultati. Questa approvazione mira ad aumentare l'accessibilità ai test per l'HIV tra gli adolescenti e a supportare una connessione precoce alle cure per coloro che risultano positivi.
OraSure Technologies (NASDAQ: OSUR) anunció la aprobación de la FDA para ampliar el rango de edad de su OraQuick® HIV Self-Test para incluir a personas a partir de 14 años, en lugar del anterior límite mínimo de 17. Esta expansión aborda una necesidad crítica, ya que los datos de los CDC muestran que el 19% de los nuevos diagnósticos de VIH en EE. UU. ocurren entre personas de 13 a 24 años, con solo el 6% de los estudiantes de secundaria habiendo sido alguna vez testeados para el VIH. Casi la mitad de los jóvenes con VIH no son conscientes de su estado.
La prueba OraQuick® HIV Self-Test ha estado disponible para los consumidores estadounidenses desde 2012. La prueba incluye materiales educativos e información sobre atención para ayudar a los usuarios a tomar decisiones informadas sin importar los resultados. Esta aprobación tiene como objetivo aumentar la accesibilidad a las pruebas de VIH entre los adolescentes y apoyar una conexión temprana con la atención para aquellos que den positivo.
OraSure Technologies (NASDAQ: OSUR)는 OraQuick® HIV Self-Test의 연령 범위를 14세 이상으로 확대하는 FDA 승인을 발표했습니다. 이는 이전의 최저 연령인 17세에서 조정된 것입니다. 이 확장은 13세에서 24세 사이의 새로운 HIV 진단의 19%가 발생하고, 고등학생 중 단 6%만이 HIV 검사를 받은 CDC 데이터로 인해 중요한 필요를 충족합니다. HIV에 감염된 젊은이의 거의 절반이 자신의 감염 상태를 모르고 있습니다.
OraQuick® HIV Self-Test는 2012년부터 미국 소비자들에게 제공되었습니다. 이 테스트는 사용자들이 결과와 관계없이 정보를 기반으로 한 결정을 내릴 수 있도록 돕기 위해 교육 자료와 치료 정보를 포함합니다. 이 승인은 청소년들 사이에서 HIV 검사 접근성을 늘리고, 양성 반응을 보이는 사람들을 조기에 치료에 연결하는 것을 지원하는 것을 목표로 합니다.
OraSure Technologies (NASDAQ: OSUR) a annoncé l'approbation de la FDA pour élargir la tranche d'âge de son OraQuick® HIV Self-Test pour inclure les individus âgés de 14 ans et plus, contre un âge minimum précédent de 17 ans. Cette extension répond à un besoin critique, car les données des CDC montrent que 19 % des nouveaux diagnostics de VIH aux États-Unis concernent des personnes âgées de 13 à 24 ans, et seulement 6 % des élèves de lycées ont déjà été testés pour le VIH. Près de la moitié des jeunes atteints du VIH ne connaissent pas leur statut.
Le test OraQuick® HIV Self-Test est disponible pour les consommateurs américains depuis 2012. Le test comprend des documents éducatifs et des informations de soins pour aider les utilisateurs à prendre des décisions éclairées, quel que soit le résultat. Cette approbation vise à accroître l'accessibilité des tests de VIH parmi les adolescents et à soutenir une connexion précoce aux soins pour ceux qui obtiennent un résultat positif.
OraSure Technologies (NASDAQ: OSUR) hat die FDA-Zulassung zur Erweiterung des Altersbereichs seines OraQuick® HIV Selbsttests für Personen ab 14 Jahren angekündigt, nachdem das vorherige Mindestalter bei 17 Jahren lag. Diese Erweiterung adressiert einen kritischen Bedarf, da die CDC-Daten zeigen, dass 19 % der neuen HIV-Diagnosen in den USA bei Personen im Alter von 13 bis 24 Jahren auftreten, während nur 6 % der Oberschüler jemals auf HIV getestet wurden. Fast die Hälfte der Jugendlichen mit HIV ist sich ihres Status nicht bewusst.
Der OraQuick® HIV Selbsttest ist seit 2012 für US-Verbraucher erhältlich. Der Test enthält Bildungsunterlagen und Pflegeinformationen, um Benutzern zu helfen, fundierte Entscheidungen zu treffen, unabhängig von den Ergebnissen. Diese Genehmigung zielt darauf ab, die Zugänglichkeit von HIV-Tests für Jugendliche zu erhöhen und eine frühzeitige Verbindung zur Pflege für diejenigen zu unterstützen, die positiv getestet werden.
- 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
- 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?
