First self collection cervical cancer test

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The FDA has approved the first at-home test in the U.S. as an alternative to the traditional Pap smear. Designed for women ages 25 to 65 who are at average risk for cervical cancer, the test will be available by prescription through a telehealth service. It allows users to collect a vaginal sample at home and send it to a lab to test for high-risk HPV, the primary cause of most cervical cancers. Experts hope this new option will improve access and boost screening rates.

Source

Fitzpatrick MB, Behrens CM, Hibler K, Parsons C, Kaplan C, Orso R, Parker L, Memmel L, Collins A, McNicholas C, Crane L, Hwang Y, Sutton E, Coleman J, Kuroki L, Harshberger K, Williams S, Jennings A, Buccini F, Gillis L, Novetsky AP, Hawkes D, Saville M, Depel T, Aviki E, Sheth SS, Conageski C. Clinical Validation of a Vaginal Cervical Cancer Screening Self-Collection Method for At-Home Use: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511081. doi: 10.1001/jamanetworkopen.2025.11081. PMID: 40388167; PMCID: PMC12090030.

Additional Reading

https://www.npr.org/2025/05/10/nx-s1-5394446/fda-cervical-cancer-screening-at-home-tool-pap-smear

https://www.nytimes.com/2025/05/09/well/pap-smear-at-home-alternative-cervical.html

https://www.washingtonpost.com/health/2025/05/09/at-home-pap-smear-fda-approval/