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.
“Many patients are uncomfortable with the intimate nature of a pelvic exam,” said Dr. Jeff Andrews, board-certified gynecologist and vice president of Global Medical Affairs for Diagnostic Solutions at BD. “Also, many people live in areas without a local doctor or clinician trained to obtain a sample with a speculum. The option to self-collect in a clinical setting can help women overcome some of these barriers.”