The US Food and Drug Administration on Friday approved the first fully at-home HPV self-collection kit for cervical cancer screening, allowing women to swab themselves and mail samples to a laboratory. The agency said the decision was intended to expand access for women who avoid routine pelvic exams.

Cervical cancer kills roughly 4,000 American women each year. The American Cancer Society estimates that more than half of cases occur in those who are under-screened or never screened. Human papillomavirus causes nearly all cervical cancers, and detecting high-risk HPV strains allows earlier intervention before malignancy develops.

Self-collection in clinical settings has been available since 2024, but the new clearance extends the practice to home use without any in-person visit. The FDA said the approved kit demonstrated accuracy comparable to clinician-collected samples in validation studies submitted by the manufacturer.

The American College of Obstetricians and Gynecologists has long urged broader self-sampling options to close screening gaps among rural, uninsured and minority women. Public health officials said the approval could meaningfully reduce cervical cancer incidence if paired with reliable follow-up for women who test positive.

"Meeting women where they are is the single most effective way to prevent cervical cancer deaths," said an FDA spokesperson in a statement accompanying the decision. "This provides a trusted, accurate option outside the clinic."