FDA approves first at-home cervical cancer screening device from Teal Health
Self-collection device allows for at-home HPV testing
For the first time, women will have an FDA-approved at-home option for their cervical cancer screening, often referred to as the Pap Smear, after the Food and Drug Administration (FDA) has approved Teal Health’s Teal Wand.
The Teal Wand is the first and only at-home self-collection device for cervical cancer screening in the United States. It has been proven to detect cervical precancer 96% of the time through human papillomavirus (HPV) testing, which is equivalent to a clinician-collection using a speculum.
“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 Teal Wand will soon be available for direct order the Teal Health website for individuals aged 25–65 at average risk. The at-home screening includes both the collection kit and an end-to-end telehealth service, providing virtual access to Teal medical providers who support women throughout their at-home screening experience.
A preventable cancer
Cervical cancer is one of the only cancers that is almost entirely preventable with regular screening, yet more than 1 in 4 women in the U.S. are behind. Whether it’s because a woman can’t get time off work, is unable to find an available appointment, or avoids the discomfort of an in-clinic exam, the Teal Wand can provide a comfortable and convenient option. The Teal Wand is a preferred alternative, one that has been built with empathy, is driven by science, and designed to make screening easy, so that more women can take control of their health on their own terms.
With the Teal Wand, women are testing for HPV (human papillomavirus), the virus that causes nearly all cervical cancers, using the same FDA-approved HPV test that medical guidelines recommend and providers use in the clinic. It is simply a different way of collecting the sample. The recommended tests have evolved from the Pap smear, which has 55% sensitivity (a measure of accuracy), to using Primary HPV as the screening, which has 95% sensitivity. With this FDA approval, women can use the same test as the doctor’s office, with the same accuracy, but collect their own sample from the privacy of their home.
Clinical evidence plus user feedback
Teal Health’s FDA approval was supported by their SELF-CERV study, the largest U.S.-based comparative study of its kind and one that was designed to reflect the racial, ethnic, and socioeconomic diversity of the U.S. population. The study confirmed that self-collected samples using the Teal Wand have the same performance as clinician-collected samples. Notably, 86% of participants said they’d be more likely to stay up to date with cervical cancer screening if they could do it at home, and 94% said they would prefer to self-collect at home with the Teal Wand if they knew it was accurate.
The clinical performance and preference for the Teal Wand, alongside Teal's comprehensive telehealth service, highlight the potential of at-home self-collection to expand access to high-quality cervical cancer screening and improve outcomes.
With FDA approval in hand, Teal Health is moving quickly to get the Teal Wand to as many women as possible. Kits will begin shipping in June, starting in California and expanding nationwide as soon as possible thereafter. Teal is working with major insurance providers and plans to have flexible payment options, helping to remove financial concerns and ensuring more women have access to this preferred at-home screening if they want it.
“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 (United States Preventive Services Task Force) draft guidelines,” said Trena Depel, Teal Health’s VP of Clinical, Regulatory, and Quality.
“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 to choose how she screens for cervical cancer.”
Beyond a device
Teal Health’s support extends beyond the device to the entire screening experience. The company’s telehealth platform ensures every woman has access to dedicated providers who support them with guidance, results, referrals, and follow-up care—helping close a critical gap in the healthcare system, where nearly 75 percent of women with abnormal results don’t take timely action due to a lack of support or clear next steps.
Teal Health’s approval contributes to a global drive to eliminate cervical cancer. The start-up is a member of the Cervical Cancer Roundtable, a joint collaboration between the American Cancer Society and the Biden Cancer Moonshot, a coalition of industry leaders with the goal of eliminating cervical cancer as a public health concern in the US.
Teal Health has so far raised $23 million to date to support its work - most recently $10 million in additional seed funding in January 2025.