Summary: The Teal Wand, an at-home cervical cancer screening device, received Breakthrough Device status from the U.S. FDA to help increase testing access for people who rarely or never screen.


  1. This designation allows the Teal Wand priority review from the FDA, ensuring timely access to the self-collection device for early cancer detection.
  2. Clinical trials validated the device’s accuracy, ease of use, and preference over traditional screening methods, with 94% of women favoring it over a clinician-collected sample.
  3. This self-collection device aims to increase access for underserved populations, significantly reducing barriers to regular screening and potentially decreasing cervical cancer rates.

Teal Health’s novel at-home self-collect cervical cancer screening device, the Teal Wand, has been granted Breakthrough Device status by the U.S. Food and Drug Administration (FDA).

FDA Breakthrough Designation

The FDA Breakthrough, which was awarded after reviewing Teal Health’s promising midpoint clinical trial data, will grant Teal Health priority status when they submit their final study data for FDA review. The program helps patients have more timely access to medical devices that could provide more effective diagnosis or treatment of life-threatening diseases and for their potential to benefit populations impacted by healthcare disparities. 

The FDA Breakthrough designation is particularly significant in that it is aimed to increase access for people who rarely or never screen or who cannot undergo a standard exam with the speculum by having an option to screen themselves at-home or in more convenient locations, says Teal Health. Teal Health joins an elite shortlist of companies that have received Breakthrough Designation within the category of microbiology, which accounts for less than 4% of all Breakthroughs awarded since the program’s inception nearly ten years ago.

The Teal Wand Cervical Cancer Screening Device

The Teal Wand is a proprietary device designed to enable people to easily, comfortably, and confidently collect their own vaginal sample for cervical cancer screening from their home or health clinic, without the need for an invasive exam. Users will mail their sample to a laboratory for testing on an FDA-approved diagnostic test for primary screening of high-risk HPV (human papillomavirus), which is recommended by medical guidelines. From within the Teal Health patient portal, users will then receive clearly communicated test results, have direct access to women’s health providers, and when appropriate receive assistance in securing follow-up care or procedures.

The Teal Wand, which is ergonomically designed for a broad range of bodies and health literacy levels, was initially tested in a 215 person study that proved women were able to collect an adequate sample and it was a much preferred experience: 97% of women said it was easy or very easy to use, 94% said they would choose self-collect over the current standard of care with a clinician collecting, and 87% said they would be more likely to get screened if the Teal Wand were an option.

“I am so grateful to the amazing team at Teal, our hardworking PIs and sites, the supportive participants in our study, and the FDA for recognizing the importance of Teal’s solution to help close the women’s cervical cancer screening gap in the U.S.,” says Kara Egan, CEO and Co-Founder of Teal Health. “The speed of our study shows that if you design for and engage with women to advance women’s health, you’ll be met with resounding enthusiasm from this group that has been overlooked and under researched for far too long. This study and Breakthrough designation is an important moment for women’s health.”

Teal Health’s Clinical Trial

Late last year, Teal Health followed their initial study with a nationwide clinical trial, titled SELF-CERV, which included 17 leading health organizations and more than 600 participants, representing people of different races/ethnicities, socioeconomic status, and sexual and gender orientation. This study was designed to validate the performance of the Teal Wand and compare results against a clinician collected sample with a speculum and brush. 

The study, which completed enrollment for its initial FDA indication this month, received an overwhelming response from women and people with a cervix, exceeding initial enrollment goals and enrolling months ahead of schedule. This speed of enrollment is uncommon in the US, where nearly 90% of studies have to double their timeline to reach their enrollment goals, of which most enroll less than 500 participants.

Lead SELF-CERV enroller, Clair Kaplan, MSN/APRN, MHS, MT(ASCP), director of clinical research and principal investigator at Planned Parenthood of Southern New England states, “The Teal Wand and self-collection really resonated with our patients and they were excited to be a part of the SELF-CERV trial. We saw upwards of an 80% enrollment rate, which more than met our expectations. I am honored to have been part of the efforts to advance cervical cancer screening and create more options for patients to get the care they need.”

Further reading: Rural-Urban Disparities in Cervical Cancer Screening

Impact of Cervical Cancer

Cervical cancer is preventable and is curable 92% of the time, however, it’s the second leading cause of cancer death among women aged 20-39 and incidence is increasing among women aged 30-44. 

More than half of cervical cancer cases are in people who are not routinely screened, which is in large part due to barriers such as discomfort during the exam, lack of information, time, and access. Studies show that women of all races and socioeconomic levels experience these barriers, with Native American, Black, and Hispanic women resulting in higher underscreened rates, says Teal Health. Self-collection will increase access and is a much preferred alternative. It has already been adopted in other countries, including Australia, which increased their screening engagement 50 fold within its first year and is now on track to eliminate cervical cancer as a public health concern by 2035.

“FDA’s recognition of the Teal Wand as a Breakthrough device acknowledges the important public health benefit that self-collection for cervical cancer screening can have on those who are rarely screened or who do not participate in clinician-based screening for cervical cancer,” says Trena Depel, Vice President of Clinical and Regulatory at Teal Health. “The clinical performance of the Teal Wand shows promise that an at-home self-collection device is possible in the near term and Teal looks forward to working closely with FDA to expedite this option to eligible women and people with a cervix.”

Photo: Teal Health