Teal Health announced the U.S. Food and Drug Administration’s (FDA) approval of the Teal Wand™, an at-home vaginal sample self-collection device for cervical cancer screening in the United States. The Teal Wand is a prescription device that will soon be available at getteal.com for individuals aged 25 to 65 years at average risk for cervical cancer. The at-home screening includes both the Teal Wand collection kit and an end-to-end telehealth service providing virtual access to Teal medical providers who prescribe the kit, review the results from the lab, and support women throughout their at-home screening experience.
Cervical cancer is one of the only cancers that is almost entirely preventable with regular screening, yet more than one in four women in the United States are behind on their screening, whether it is because they are not able to get time off from work, are unable to find an available appointment, or are avoiding the discomfort of an in-clinic exam.
With the Teal Wand, women are testing a sample for human papillomavirus (HPV) using the same highly accurate HPV test that medical guidelines recommend and providers use in the clinic—cobas® HPV from Roche—the device provides a different method of sample collection. 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; the sample is then shipped to a certified lab for processing.
SELF-CERV
The Teal Wand’s FDA approval was supported by the SELF-CERV study, the largest U.S.-based comparative study of its kind. The study confirmed that self-collected samples using the Teal Wand have the same performance as clinician-collected samples, proven to detect cervical precancer 96% of the time, and that the Teal Wand is a much-preferred experience by patients. Study participants reflected the racial, ethnic, and socioeconomic diversity of the U.S. population. Notably, 86% of participants said they would 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.
“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 U.S. 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,” said Christine Conageski, MD, Associate Professor, OB-GYN, and Director of the Complex Dysplasia Clinic at the University of Colorado. “But access is only part of the solution. Comprehensive screening must go hand-in-hand with structured, reliable follow-up. That’s why Teal Health’s approach to not only advancing screening technology but also providing education and support to women through every step of their care and follow-up journey is crucial. That’s how we ensure this breakthrough truly closes the gap.”
Teal Health is moving quickly to get the Teal Wand to as many women as possible. Kits will become available 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.
“The FDA prioritized the review of at-home self-collection, recognizing its potential to increase cervical cancer screening adherence, as emphasized in the recent 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 is] a win for every woman who deserves a rigorously tested and FDA-reviewed at-home cervical cancer screening option.”
