FDA approves first cervical cancer screening device that can be used at home, company says
- The FDA approved Teal Health's Teal Wand on May 9, 2025, as the first cervical cancer screening kit for at-home sample collection in the U.S.
- This approval responded to low screening rates, as only one in four women receive regular cervical cancer tests despite CDC guidelines.
- Teal Wand uses a swab inserted into the vagina to collect samples detecting HPV, the virus causing over 99% of cervical cancers, which are mostly sexually transmitted infections.
- The company, based in San Francisco, will first market the prescription-required kit in California starting next month while working with insurers like Aetna to expand access.
- This device may increase screening convenience and coverage, addressing inadequate screening linked to most cervical cancer cases and potentially improving early detection and treatment.
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Head and neck cancer researchers are reporting the development and testing of HPV-DeepSeek, a novel liquid biopsy assay. In their new study, HPV-DeepSeek achieved 99% sensitivty and specifity for diagnosing HPV-associated head and neck cancers, outperforming standard of care methods. HPV causes about 70% of oropharyngeal cancers in the U.S., which are increasing in incidence faster than other head and neck cancers.

Teal Health Announces Publication of SELF-CERV Study Results in JAMA Network Open Following FDA Approval of Teal Wand™ for At-Home HPV Screening
SAN FRANCISCO, May 19, 2025 /PRNewswire/ -- Following its recent FDA approval, Teal Health® announced the publication of its multi-center pivotal SELF-CERV study in JAMA Network Open. The study supported the recent U.S. Food and Drug Administration (FDA) approval of…
FDA Approves At-Home Cervical Cancer Test with Promising Impact - One Green Planet
A new FDA-approved at-home test for cervical cancer could close screening gaps and help save lives with a simple, painless swab. The post FDA Approves At-Home Cervical Cancer Test with Promising Impact appeared first on One Green Planet.
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