FDA approves self-collection screening tests for HPV, allowing women to avoid pelvic exams for cervical cancer

The FDA has approved two diagnostic devices that allow women to collect vaginal samples themselves for cervical cancer screening—a major step toward catching more early and potentially preventable cases without requiring an invasive gynecological exam.

The separate self-collection offerings from BD and Roche still need to be used in a healthcare setting—they have not received agency green lights for solo, at-home use—but the two companies said the move could improve access to screening by enabling HPV testing at locations such as retail pharmacies or mobile clinics.

HPV, or human papillomavirus, causes nearly all cases of cervical cancer, but Pap smear tests to spot the signs of infection have traditionally been performed by a clinician using stirrups and a speculum.

“Many patients are uncomfortable with the intimate nature of a pelvic exam,” said Jeff Andrews, BD’s vice president of global medical affairs for diagnostics and a board-certified gynecologist.

“Also, many…
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