The U.S. Food and Drug Administration (FDA) has approved a new at-home cervical cancer screening device called the Teal Wand. This marks a significant advancement in women’s healthcare, providing a more accessible and comfortable method for detecting cervical cancer.
The Teal Wand is the first FDA-approved at-home kit for self-collection of vaginal samples for cervical cancer screening in the U.S. It enables women to collect a sample from the privacy of their homes, eliminating the need to visit a clinic for a Pap smears test which is uncomfortable and inconvenient.
Available by prescription, the Teal Wand will soon be offered to women aged 25 to 65 who are at average risk for cervical cancer. In addition to the device, users receive access to a comprehensive telehealth service. Teal’s medical professionals provide support through each step from prescribing the kit to reviewing lab results and providing follow-up guidance.
Cervical cancer is among the most preventable forms of cancer when detected early through regular screening. However, over 25% of women in the U.S. are not screened within the recommended time frame because of busy schedules, limited appointment availability, personal fears, or discomfort with in-clinic examinations.
Teal Health is working to address this gap by offering a screening method that is comfortable, accurate, and discreet. “It’s not just about introducing a new medical tool; it’s about changing how care is delivered,” said Kara Egan, CEO and Co-Founder of Teal Health. “I understand how easy it is to put off your own health needs. Now, we’re offering a solution that fits real life.”
The Teal Wand collects samples for the HPV (human papillomavirus) test – the virus responsible for nearly all cases of cervical cancer. It utilizes the same high-quality test found in clinics, the cobas HPV test from Roche, but allows women to collect their sample at home. This marks a shift from the traditional Pap smear to the more accurate method of HPV primary screening.
The FDA approval of the Teal Wand was based on results from Teal’s SELF-CERV study, the largest study of its kind in the U.S. The study confirmed that self-collected samples are as effective as physician-collected ones, detecting cervical precancer 96% of the time. It also showed that most women preferred the at-home method. In fact, 86% of women said they would be more likely to stay up to date with screenings if they could test at home, and 94% stated they would use the Teal Wand if it were proven to be accurate.
Lead study investigator Dr. Christine Conageski described the FDA approval as a breakthrough milestone, emphasizing that it is equally important for expanding access and ensuring reliable follow-up care. She noted that Teal’s service supports users throughout the entire screening process, offering educational resources and telehealth guidance to help them understand and act on their results.
According to Trena Depel, Teal Health’s Vice President of Clinical, Regulatory, and Quality, the FDA prioritized the Teal Wand’s review due to its potential to improve cervical cancer screening rates and health outcomes significantly. With this approval, Teal Health is advancing personalized, patient-friendly healthcare, empowering women to manage their health independently.
Reference: Teal health. FDA Approves Teal Health’s Teal Wand™—The First and Only At-Home Self-Collection Device for Cervical Cancer Screening, Introducing a Comfortable Alternative to In-Person Screening. Published May 9, 2025. Accessed May 12, 2025. FDA Approves Teal Health’s Teal Wand™—The First and Only At-Home Self-Collection Device for Cervical Cancer Screening, Introducing a Comfortable Alternative to In-Person Screening
