May 16, 2024- BD announced U.S. 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.
HPV is the cause of virtually all cervical cancer, and HPV testing is the preferred screening method by the American Cancer Society in the United States. 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.