Teal Health Completes Clinical Trial at Record Speed and Receives FDA Breakthrough Designation for Its At-Home Cervical Cancer Screening Device, the Teal Wandtm

In the last 6 months, Teal Health and their clinical study partners exceeded their study enrollment numbers months ahead of schedule, produced strong clinical performance data, and was granted FDA Breakthrough status to help accelerate the review of their self-collect cervical cancer screening device.

SAN FRANCISCO, May 8, 2024 /PRNewswire/ -- Teal Health, a woman-led company on a mission to get all women and people with a cervix in the US screened for cervical cancer, is one step closer to bringing at-home cervical cancer screening to the US after being granted Breakthrough Device status by the US Food and Drug Administration (FDA) for its novel at-home self-collect cervical cancer screening device, the Teal Wand^TM. 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. With 1 in 4 US women not up-to-date on their cervical cancer screening, this 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. 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 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 US. 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," expresses Kara Egan, CEO and Co-Founder of Teal Health.

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."

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. 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. 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," states Trena Depel, Vice President of Clinical and Regulatory at Teal Health.

About Teal Health
Teal Health is on a mission to design a better healthcare experience for women - starting with cervical cancer screenings. By creating the option for a woman to collect her own screening sample from the comfort of her home or health clinic and providing telehealth follow-up, Teal can increase access to this critical screening. Teal Health is a member of the Cervical Cancer Roundtable, a joint collaboration between the American Cancer Society and the Biden Cancer Moonshot, a coalition of industry leaders with the goal of eliminating cervical cancer as a public health concern in the US. To learn more, visit www.getteal.com or follow Teal on Twitter at @tealhealth.

SOURCE Teal Health