The Food and Drug Administration (FDA) has expanded the approval of two tests, Onclarity HPV and cobas HPV, to allow individuals to self-collect vaginal samples for human papillomavirus (HPV) testing in a healthcare setting, a move intended to increase cervical cancer screening rates. The May 14th approval allows patients to collect their own samples, using a swab or brush, under the supervision of healthcare professionals in locations like primary care offices, urgent care centers, pharmacies, and mobile clinics.
Currently, cervical cancer screening in the United States typically requires a sample of cells collected from the cervix during a pelvic exam performed by a healthcare provider. The expanded approval addresses barriers to screening, particularly for individuals who may be hesitant or unable to undergo a pelvic exam. According to the American Cancer Society, regular screening is crucial for preventing cervical cancer or detecting it early, when treatment is most effective. The organization recommends testing for women and anyone with a cervix starting at age 25.
The FDA’s decision follows evidence suggesting that self-collected samples perform similarly to those collected by clinicians in laboratory settings. Vikrant Sahasrabuddhe, of the National Cancer Institute’s Division of Cancer Prevention, stated that the availability of self-collection in healthcare settings should widen access to screening, particularly for populations with historically low screening rates. He characterized the current approvals as a “first step” toward broader approvals, including the possibility of at-home self-collection, contingent on further evidence gathered through the NCI-led “Last Mile” Initiative.
The American Society for Colposcopy and Cervical Pathology (ASCCP) has too issued guidance supporting self-collection for cervical cancer screening, noting that the majority of cervical cancers in the United States occur among individuals who are unscreened or under-screened. Primary HPV screening is the preferred method endorsed by draft guidelines from the U.S. Preventive Services Task Force and the American Cancer Society.
While the FDA has approved these tests for use in healthcare settings, questions remain regarding insurance coverage for self-collected HPV tests. The American Cancer Society notes that coverage varies, and individuals should check with their insurance providers. The accuracy of self-collected tests is also an area of ongoing evaluation, with studies indicating high participation and satisfaction rates among individuals who choose this method.
The FDA’s approval of self-collection tests is limited to use within a healthcare setting. The agency has not yet approved at-home self-collection, and further research is needed to assess the feasibility and accuracy of this approach. The Last Mile Initiative is designed to accelerate the development and approval of broader self-collection options, including at-home testing.
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