FDA Approves HPV Tests That Allow for Self-Collection in a Health Care Setting
Posted on July 25, 2024
Source: National Cancer Institute
The Food and Drug Administration (FDA) expanded the approvals of two tests that detect cancer-causing types of human papillomavirus (HPV) in the cervix. Both tests are used as part of screening for cervical cancer.
Under these expanded approvals, people can now be offered the option to collect a vaginal sample themselves for HPV testing if they cannot have or do not want a pelvic exam. However, the collection, which involves a swab or brush, must be done in a health care setting, such as primary care offices, urgent care, pharmacies, and mobile clinics.
The tests included in the approvals are Onclarity HPV, made by Becton, Dickinson and Company (BD), and cobas HPV, made by Roche Molecular Systems.
Until now, screening for cervical cancer in the United States has required a sample of cells collected from the cervix during a pelvic exam performed by a health care professional. But the availability of a self-collection option in health care settings should help widen access to screening.
Increased access to HPV testing is a particular need for certain populations among which rates of cervical cancer screening continue to be low.