OraSure Technologies, Inc. announced that the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has approved a labeling change for the OraQuick® HIV Self-Test. This change expands the approved age range for the test to include individuals 14 years of age and older, a reduction from the previous approval for those 17 and older.
This expansion is significant as it increases access to HIV testing for adolescents, a population with a notable need. According to the Centers for Disease Control & Prevention, an estimated 19 percent of new HIV diagnoses in the United States are among young people aged 13 to 24, and almost half of young people with HIV are unaware of their status.
The OraQuick® HIV Self-Test has been available direct to consumers in the U.S. since 2012, and this approval allows OraSure to further promote HIV testing and help more individuals know their HIV status. The company emphasizes that increasing access to different testing options is critical for early connection to care for adolescents who test positive.
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