FDA Approves First At-Home Cervical Cancer Screening Device

The US Food and Drug Administration has approved the "Teal Wand," an at-home cervical cancer screening tool, as an alternative to Pap smears conducted by a gynecologist. Developed by Teal Health, this self-collection vaginal swab, shaped like a tampon, will be accessible online for individuals aged 25 to 65 who are at average risk for cervical cancer. Users can request a kit online, participate in a brief telehealth consultation to determine eligibility, and upon prescription, collect a sample to be sent to a lab for analysis.
Cervical cancer, affecting the lower part of the uterus, is diagnosed in approximately 0.6 percent of women. While HPV vaccination and regular screening are highly effective in preventing the disease, more than one in four women are not up-to-date with routine appointments. Kara Egan, CEO of Teal Health, stated, "When we make care easier to get, we help women stay healthy, for themselves and for the people who rely on them every day."
The Teal Wand tests for high-risk strains of human papillomavirus (HPV), the primary cause of cervical cancer. Clinical trials have demonstrated that its accuracy is comparable to that of a traditional Pap smear, which requires a speculum and is often cited as a barrier to screening due to discomfort. While most sexually active individuals will contract HPV at some point, only a small fraction develop cancer.
Each Teal Wand kit includes instructions for connecting with telehealth providers who can prescribe the test, interpret the results, and guide users through the process. Teal Health has not yet disclosed the pricing but is in discussions with insurers to ensure affordability. The product is scheduled to launch first in California in June.