FDA Approves Teal Wand, First At-Home Self-Collection Cervical Cancer Screening Device

The FDA approved the Teal Wand (Teal Health), which is the first and only at-home vaginal sample self-collection device used for cervical cancer screening within the US. The approval is supported by clinical trial results from the SELF-CERV study (NCT06120205), in which approximately 94% of enrolled women reported their preference for the self-collection method over an in-person screening visit at a health care professional’s office.^1-3

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About Cervical Cancer

Cervical cancer is one of the only cancers that is almost entirely preventable with regular screening; however, over 1 in 4 US women are often behind on screenings, with the most common reasons being the inability to take time off work, the inability to find an available appointment, and the discomfort experienced during an in-clinic exam. Cervical cancer screenings, commonly referred to as a Pap smear, are critical to a woman’s health, but they are inconvenient and uncomfortable for most. Specifically, people report experiencing pain, nervousness, and discomfort with the speculum during the screening, and 32% report delaying their screening because of discomfort alone. For these reasons, experts sought a screening method that is as accurate as going to a health clinic or specialist’s office while also being comfortable and able to be conducted at home.^1,3

What is the Teal Wand?

The Teal Wand is a prescription device that is indicated for individuals aged 25 to 65 years of age who are at average risk. The at-home screening includes both a collection kit and an end-to-end telehealth service providing virtual access to health care providers who prescribe the kit, review the results from the lab, and support users throughout their at-home screening experience. With the device, women are testing a sample for human papillomavirus (HPV)—the virus that causes nearly all cervical cancers—using the same highly accurate HPV test, cobas® HPV (Roche), that medical guidelines recommend and providers use in the clinic.^1,3 Although similar vaginal tests were approved last year for use in medical offices, according to The New York Times, an at-home version can be significant for improving adherence and timeliness when scheduling screenings.⁴

Further, the Teal Wand provides a different method of sample collection. Cervical cancer screening has evolved from the Pap smear to HPV primary screening, and this method demonstrates higher sensitivity compared with the Pap test to better identify women who may be at risk of cervical cancer. This FDA approval grants women the opportunity to receive the same test at a health care professional’s office with the same accuracy, but they collect their own sample from the privacy and comfort of their home. Following collection, samples are shipped to a lab for testing.

“As a mom and a woman, I get how easy it is to put your own health last,” Kara Egan, CEO and cofounder of Teal Health, said in a news release. “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 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."¹

The SELF-CERV Study

The FDA approval of Teal Wand was supported by the SELF-CERV trial (NCT06120205), which was the largest comparative US study. The study confirmed that self-collected samples utilizing the Teal Wand have the same performance as health care professional-collected samples, which are proven to detect cervical precancer about 96% of the time. Overall, participants reported that the Teal Wand is a much-preferred experience.

Study participants reflected the racial, ethnic, and socioeconomic diversity of the US. According to the study’s clinicaltrials.gov page, 870 participants across 16 sites were enrolled. Most participants were aged 30 to 39 years (44%), with those aged 25 to 29 years the second most prominent age range (25%). The primary outcome measures were efficacy of detection of hrHPV in self-collected samples and the rate of serious adverse events (AEs).^1-3

“As a Principal Investigator in the SELF-CERV trial, I saw firsthand how receptive and excited women were to use the Teal Wand. Cervical cancer is largely preventable, yet screening rates in the US continue to lag, and the FDA approval of this at-home Teal Wand self-collection device is a critical step forward. It offers an evidence-based way to expand access without compromising accuracy,” Christine Conageski, MD, MSc, associate professor, obstetrician/gynecologist, and director of the Complex Dysplasia Clinic at the University of Colorado, said in the news release. “But access is only part of the solution. Comprehensive screening must go hand in hand with structured, reliable follow-up.”¹

Following screening with the Teal Wand, 98% of participants successfully collected a valid sample with the device, and 92% and 39% reported being able to collect a sample within 5 minutes and 2 minutes, respectively. Notably, 86% of participants reported they would be more likely to stay up to date with cervical cancer screening if they were able to complete it at home, and 94% said they would prefer to self-collect at home with the device if they knew it was accurate. The experts predict that across all racial and ethnic groups, screening engagement can increase by up to 20% from where adherence rates are today.^1,3

Teal Wand kits will become available in June, beginning in California and expanding nationwide as soon as possible, according to a Teal Health news release.¹

“After awarding the Teal Wand [a] 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 [us]—it’s a win for every woman who deserves a rigorously tested and FDA reviewed at-home cervical cancer screening option,” Trena Depel, vice president of clinical, regulatory, and quality at Teal Health, said in the news release.¹

REFERENCES

1. 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. News release. May 9, 2025. Accessed May 9, 2025. https://www.getteal.com/news/fda-approves-teal-healths-teal-wand-tm---the-first-and-only-at-home-self-collection-device-for-cervical-cancer-screening-introducing-a-comfortable-alternative-to-in-person-screening

2. SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening. ClinicalTrials.gov identifier: NCT06120205. Updated March 26, 2025. Accessed May 9, 2025. https://clinicaltrials.gov/study/NCT06120205

3. Teal Health. U.S. Clinical Study Demonstrates At-Home Screening is as Accurate as In-Clinic and Preferred by 94% of Women. May 9, 2025. Accessed May 9, 2025. https://www.getteal.com/research/u-s-clinical-study-demonstrates-94-of-women-prefer-at-home-cervical-cancer-screening

4. Astor M. F.D.A. Approves First At-Home Alternative to the Pap Smear. The New York Times. May 9, 2025. Accessed May 9, 2025. https://www.nytimes.com/2025/05/09/well/pap-smear-at-home-alternative-cervical.html?unlocked_article_code=1.F08.xQ6O.0ym9HA4eI4ln&smid=nytcore-ios-share&referringSource=articleShare&login=smartlock&auth=login-smartlock