BD receive US FDA approval for Onclarity HPV assay

Becton, Dickinson and Company (BD) has announced the US Food and Drug Administration (FDA) approval for the use of self-collected vaginal specimens for human papillomavirus (HPV) testing when cervical specimens cannot otherwise be obtained.

The approval allows women to self-collect vaginal specimens for HPV testing in a health care setting, which could include non-traditional locations such as a retail pharmacy or mobile clinic.

The BD Onclarity HPV Assay is FDA-approved for HPV primary testing without the need for a traditional Pap smear performed with a speculum. This new approval of self-collected samples opens the door to a less invasive testing option, and it improves access to testing for individuals who face barriers to cervical cancer screening.

Cervical cancer is preventable, and screening plays a crucial role in early detection and prevention. According to the American Cancer Society, approximately 50% of cervical cancer diagnoses are in never-screened people, and 10% of diagnoses occurs in under-screened individuals. In addition, 25% of women in the U.S. do not receive regular cervical cancer screening, according to the National Cancer Institute.