FDA OKs Teal Wand Self-Collection Device for Cervical Cancer Screening

Teal Health, a women’s health company focused on eliminating cervical cancer, has earned U.S. Food and Drug Administration (FDA) approval for the Teal Wand.

Teal Wand is touted as the first, only at-home vaginal sample self-collection device for cervical cancer screening in the U.S.

Cervical cancer screenings, also known as Pap smears, are critical to women’s health but inconvenient and uncomfortable for most. The Teal Wand offers way as accurate as going to the doctor’s office and is comfortable.

The prescription device is available for people aged 25-65 at average risk of cervical cancer. The at-home screening includes a collection kit and end-to-end telehealth service for virtual access to Teal medical providers who prescribe the kit, review the results from the lab, and support women throughout their at-home screening.

Using the Teal Wand tests for HPV, the virus that typically causes almost all cervical cancers. It uses the same HPV test that medical guidelines recommend and providers use in the clinic, the cobas HPV test from Roche.

The FDA approval was backed by the company’s SELF-CERV study, which was the largest U.S.-based comparative study of its kind. It confirmed self-collected samples using the Teal Wand exhibit the same performance as samples collected by a physician, detecting cervical precancer 96% of the time. Participants reflected the racial, ethnic, and socioeconomic diversity of the U.S. population.

86% of study participants said they’d be more likely to remain current with cervical cancer screening if it could be done from home. 94% said they’d prefer to self-collect at home with the Teal Wand if they knew it was accurate.

“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 Dr. Christine Conageski, 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.”

“As a mom and a woman, I get how easy it is to put your own health last,” said Kara Egan, co-founder and CEO 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 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.”