FDA approves Teal Wand for at-home cervical cancer screening

FDA approves Teal Wand for at-home cervical cancer screening | Image Credit: © Postmodern Studio - © Postmodern Studio - stock.adobe.com.

The Teal Wand, the first at-home vaginal sample self-collection device to identify cervical cancer in US women, received approval from the FDA on May 9, 2025, according to a press release from Teal Health.¹

An alternative to traditional pap smears

Pap smears are traditionally utilized to screen for cervical cancer, but many women find this method to be inconvenient and uncomfortable. The Teal Wand is a comfortable method that may be performed from home among women aged 25 to 65 years with average risk, providing equal accuracy to a test performed at the doctor’s office.¹

“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,” said Christine Conageski, associate professor, University of Colorado, in a statement. “It offers an evidence-based way to expand access without compromising accuracy.”¹

Efficacy demonstrated in SELF-CERV study

The approval occurred following the SELF-CERV study, a trial evaluating the efficacy of self-collected samples using the Teal Wand. Results indicated 96% accuracy for identifying cervical precancer. Participants reported a preference for using the Teal Wand, as 94% preferred Teal Wand for collection if they knew it was accurate, and 86% reported they would be more likely to stay up to date with cervical cancer screening if it could be performed at home. These patients represented a diverse racial, ethnic, and socioeconomic population, according to Teal Health.¹

Availability and study insights

In June, the first Teal Wand kits will be available in California, expanding nationwide access as part of Teal Health’s goal to make the device available to as many women in the United States as possible. With support from major insurance providers, Teal Health aims to allow for flexible payment options to reduce financial issues and increase access.¹

According to the company, 1 in 4 US-women are currently behind on their cervical cancer screening.² The SELF-CERV study was a 16-site clinical trial conducted in 2024, comparing the performance of the Teal Wand to a clinician-collected sample using a speculum and brush.

Positive Percent Agreement (PPA), defined as the rate of self-collected samples identified at HPV-positive, was reported as the primary outcome. Endpoints were met on both measures for the Teal Wand, with a PPA of 95% and Negative Percent Agreement of 90%.²

Reducing barriers to care

By identifying HPV infections, the Teal Wand provides patients an opportunity to seek follow-up care. This reduces the barrier of discomfort, which 32% of women reported as a factor contributing to delayed screening. Additionally, 32% highlighted insurance having delayed or avoided their screening, indicating the importance of flexible payment.²

Of participants, 98% completed a valid sample using the Teal Wand, with 92% managing to perform collection in under 5 minutes and 39% in under 2 minutes. Ninety-three percent reported the Teal Wand was easy or very easy to use. This highlighted the Teal Wand as a method more likely to make participants engage in routine screening rather than delaying the process.²

“Comprehensive screening must go hand in hand with structured, reliable follow-up,” said Conageski. “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.”¹

References:

1. 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. Teal Health. May 9, 2025. Accessed May 12, 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. US clinical study demonstrates at-home screening is as accurate as in-clinic and preferred by 94% of women. Teal Health. May 9, 2025. Accessed May 12, 2025. https://www.getteal.com/research/u-s-clinical-study-demonstrates-94-of-women-prefer-at-home-cervical-cancer-screening.