MedPage Today May 9, 2025
Previously approved self-collection kits need to be used in a healthcare setting
The FDA approved the first at-home test for cervical cancer screening in people at average risk ages 25 to 65, maker Teal Health announced on Friday.
The test is comprised of a wand with a sponge-like tip for collecting cells (Teal Wand) and does not require a speculum. Patients then ship their sample to a certified lab for processing.
FDA last year approved the first self-collection kit for detecting human papillomavirus (HPV) — the virus that causes nearly all cervical cancers — but only for use in healthcare settings. The new at-home device uses the same Roche testing system, cobas HPV, which is used for primary screening and...
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