FDA Clears First At-Home Pap Smear Alternative for Cervical Cancer Screening: Daily Dose
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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
On May 12, 2025, we reported on the US FDA approval of the Teal Wand, an at-home vaginal sample self-collection device for cervical cancer screening that uses the same human papillomavirus (HPV) test recommended by medical guidelines and used in clinical settings.
The approval
The prescription device, which will be available for women aged 25–65 years at average risk for cervical cancer, allows users to collect their own sample at home without the use of a speculum. The Teal screening box is mailed and includes testing materials and conveyance for returning the test via mail to the lab. Results are shared via a secure patient portal, and medical providers are available virtually to discuss results and support with any follow-up care according to established medical guidelines.
The approval was based on data from the SELF-CERV study, described as the "largest US-based comparative study of its kind." Investigators compared results obtained using vaginal samples collected at home with the Teal Wand against clinician-collected samples using the traditional speculum and brush technique. Results showed that samples collected using the Teal Wand detected cervical precancer 96% of the time, matching the performance of samples collected by clinicians. Also, the Teal Wand had a 95% Positive Percent Agreement with clinician-obtained samples and a 90% Negative Percent Agreement. Among participants, 86% said they would be more likely to stay up to date with cervical cancer screening if they could self-collect at home, and 94% preferred self-collection if assured of its accuracy.
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