BD begins shipments in U.S. of FDA-approved self-collection tests for cervical cancer
BD (Becton, Dickinson and Company) announced the first shipments of its human papillomavirus (HPV) self-collection kits to healthcare facilities in the U.S., which supports national and global initiatives to eradicate cervical cancer.
This is the first FDA-approved test available in the U.S. that provides a less invasive and more private option than traditional Pap smears for women. The test expands access to potentially life-saving cervical cancer screening to non-traditional settings like retail pharmacies and mobile clinics.
The BD Onclarity HPV Assay was recently FDA-approved for HPV primary testing without the need for a traditional Pap smear, which is performed with stirrups and a speculum. For a variety of reasons ranging from past experiences, or social or religious preferences, many women are not comfortable with the pelvic exam required for a traditional Pap smear. The availability of self-collection provides a less invasive testing option, potentially improving access to testing for individuals who face barriers to cervical cancer screening, including for those in geographic areas where there is not a clinician trained to perform cervical examinations.
BD Onclarity reports six HPV strains individually.