In a milestone decision for women’s health, the U.S. Food and Drug Administration has approved Teal Health’s self-collection device for cervical cancer screening, marking the first time such a test can be done entirely at home in the country.
The device, known as the Teal Wand, is designed for women aged 25 to 65 who are at average risk for cervical cancer. It allows users to collect their own sample for HPV testing the virus responsible for nearly all cervical cancer cases. Clinical studies have shown that the device is able to detect cervical precancer with 96% accuracy, a rate comparable to traditional in-clinic screening performed by medical professionals using a speculum.
Teal Health’s kit includes not just the collection tool, but access to a full telehealth experience. Medical professionals from the company support users through the entire process, from collection to results and follow-up.
“As a mom and a woman, I get how easy it is to put your own health last,” said Kara Egan, CEO and Co-Founder of Teal Health. “That’s why this FDA approval means so much; it’s not just about an innovative new product, it’s about finally giving women an option that actually makes sense for their lives – something that can be done quickly and comfortably at home. Because 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 need for more accessible screening options is significant.Teal Health points out that over 25% of women in the U.S. are overdue for cervical cancer screenings. Factors such as limited appointment availability, time constraints, and discomfort with in-clinic procedures have contributed to this trend.
The FDA’s approval followed a review of data from the SELF-CERV study, the largest of its kind conducted in the United States. The study found that self-collected samples using the Teal Wand were as effective as those collected by clinicians. Feedback from participants was overwhelmingly positive, 86% said the option of at-home testing would help them stay on track with screenings, while 94% indicated a preference for self-collection when assured of its reliability.
Teal Health’s Vice President of Clinical, Regulatory, and Quality, Trena Depel, noted the FDA’s responsiveness to the growing need for innovation in this space. “The FDA prioritized the review of at-home self-sampling, recognizing its potential to increase cervical cancer screening adherence, as emphasized in the recent USPSTF draft guidelines,” she said. “After awarding the Teal Wand Breakthrough Device Designation, the FDA stayed committed to a timely review, leading to approval of a technology that delivers meaningful performance, benefits, and choice. This isn’t just a win for Teal—it’s a win for every woman who deserves a rigorously tested and FDA reviewed at-home cervical cancer screening option”
The at-home kits are set to begin distribution in June, starting in California and expanding nationwide later in the year. Teal Health is working with insurance providers to improve affordability and will offer flexible payment options. Their digital platform also ensures that users receive support and guidance throughout the screening process, something that could help reduce the number of women who delay or skip follow-up care after receiving abnormal results.
