Summary: OraSure Technologies announced FDA approval for expanding the age range of its OraQuick HIV Self-Test to individuals aged 14 and older, increasing access to HIV testing for adolescents.
Takeaways:
- The FDA’s approval of the OraQuick HIV Self-Test for individuals aged 14 and older broadens access to critical HIV testing for a vulnerable age group, previously limited to those 17 and older.
- Adolescents are disproportionately affected by HIV, with nearly 19% of new U.S. cases occurring in those aged 13–24, and testing rates among high school students remain alarmingly low.
- OraSure’s test packaging includes comprehensive educational resources and connections to care, emphasizing early detection, treatment, and stigma reduction to help end the HIV epidemic.
OraSure Technologies, a provider in point-of-need and home diagnostic tests and sample management solutions, 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.
Impact of HIV on Adolescents
According to the most recent data available from the Centers for Disease Control & Prevention, it is estimated that 19% of new HIV diagnoses in the United States were among young people aged 13 to 24, and only 6% 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,” says 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.”
Further Reading
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.
