F.D.A. Approves First At-Home Alternative to the Pap Smear

The Food and Drug Administration approved the United States’ first at-home cervical cancer screening tool on Friday, a decision that stands to give women an accessible alternative to Pap smears, which many find painful or traumatic.

The new test, made by Teal Health, involves swabbing the vagina with a spongelike tool rather than inserting a speculum and scraping cells from the cervix, as health care providers do in Pap smears.

Similar vaginal tests were approved last year for use in medical offices. But the at-home version could help women who have trouble finding, traveling to or making time for an in-person appointment.

The approval is a result of a process that began with the discovery decades ago that the human papillomavirus, commonly known as HPV, causes almost all cervical cancer cases, and that people who don’t have the virus are at virtually no risk.

Armed with that information, many providers started testing Pap smear samples for HPV in addition to analyzing cervical cells under a microscope. Some medical authorities shifted to recommend HPV testing as the primary screening method, which opened the door for vaginal tests, because the virus can be detected in vaginal as well as cervical cells.

Cervical cancer experts told The New York Times that the evidence for at-home testing was strong, and studies show it to be about as accurate as Pap smears.

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