FDA Approves First At-Home Cervical Cancer Screening Device

The FDA has approved the first at-home cervical cancer screening device in the U.S., developed by Teal Health, which offers a more comfortable and private alternative to traditional Pap smears. The device, shaped like a tampon, allows women to self-collect vaginal samples that are mailed to a lab for HPV testing, the virus responsible for nearly all cervical cancers. Studies show self-collected samples are as accurate as clinician-collected ones and that women prefer this method, which could improve screening rates, especially among those who avoid or delay in-office screenings due to discomfort or access issues. After mailing the sample, patients can discuss results via telehealth, and if abnormal, they are referred for further care. This innovation aims to reduce cervical cancer deaths by overcoming barriers such as the unpleasantness of speculum exams and healthcare deserts, with coverage expected through insurance and plans for wide availability. While the test does not replace pelvic exams entirely, experts consider HPV screening the most important part of cervical cancer detection, making this device a significant step toward eliminating cervical cancer in the U.S.