Medical Research
U.S. Clinical Study Demonstrates At-Home Screening is as Accurate as In-Clinic and Preferred by 94% of Women
May 9, 2025
Closing the Cervical Cancer Screening Gap
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Our data shows how the Teal Wand can help close the screening gap in the United States, where currently 1 in 4 women are behind on their cervical cancer screening.
Download our SELF-CERV Study Data Report to see clinical results from our nationwide study, the demographic profile of our participants, and our strong preference and usability outcomes, demonstrating the demand for an accurate at-home screening method.
Nationwide 600+ person study
In 2024, Teal Health led a nationwide, 16-site clinical trial, titled SELF-CERV. The study was designed to validate the performance of the Teal WandTM vaginal sample at-home self-collection device and compare results against a clinician-collected sample using a speculum and brush.
The current screening method: Often referred to as a Pap smear (using the speculum) greatly reduced cancer incidence from when it was first introduced more than 80 years ago. But screening rates have dropped 10% in the last decade4, often because people cannot access a clinic or find the speculum painful or uncomfortable. Younger women are being diagnosed with cervical cancer most frequently - an alarming trend that demands correction.
The Teal WandTM: To help close the screening gap and increase access to this life-saving screening, Teal Health designed the Teal Wand, a patented, vaginal sample at-home self-collection device that enables women and people with a cervix to collect their own vaginal sample from home, with ease, comfort, and accuracy. The sample you collect with the Wand is tested for high-risk HPV on an FDA-approved assay.
The study exceeded all clinical endpoints for both safety and efficacy. We also collected extensive feedback about the preferences and usability of the Teal Wand to ensure we are delivering on our promise of an easy-to-use, comfortable cervical cancer screening experience for all.
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Report Overview
PART 1: Study Demographics and Overall Participation
PART 2: Clinical Outcomes for HPV Detection Using the Teal Wand
PART 3: Delays and Barriers to In-Clinic Cervical Cancer Screening
PART 4: Preferences and Usability for At-Home Self-Collection Using the Teal Wand
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PART 1
Study Demographics and Overall Participation
The SELF-CERV study included more than 600 participants representing different ages, races, ethnicities, education levels, socioeconomic statuses, and sexual orientations.
The study collected a comprehensive range of perspectives and health experiences, enabling conclusions that are widely applicable and representative of the US screening-aged population.
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The study represented women and people with a cervix between 25-65 years of age, which is the American Cancer Society’s recommended Primary HPV screening age range7.
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The SELF-CERV study shows that at-home self-collection is a critical option for many, including those of diverse sexualities and gender identities. At-home screening with the Wand will enable more people to participate in routine life-saving cancer screening, closing the screening gap.
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PART 2
Clinical Outcomes for HPV Detection Using the Teal Wand
Positive Percent Agreement
The key clinical endpoint of the SELF-CERV study was to evaluate Positive Percent Agreement (PPA), which is the percentage of self-collected samples that were correctly identified as “HPV positive” when compared to clinician-collected results that were HPV positive.
In other words, PPA tells us how many self-collected samples using the Wand matched the clinician-collected samples in detecting HPV infections. This is the most important outcome in determining the effectiveness of at-home self-collection using the Teal Wand.
Teal exceeded endpoints on both these measures, with a 95% Positive Percent Agreement and a 90% Negative Percent Agreement.
Sensitivity
It is critical that any cervical cancer screening test is able to detect an HPV infection early, as a precancer, before it has progressed into cancerous cell changes. These precancers are classified as low- or high-grade in terms of severity and risk for developing into cervical cancer. Almost all cervical precancers result from HPV infections.
We analyzed how well the Teal Wand (compared to the clinician-collection) was able to detect precancer related to high-risk HPV.
The Teal Wand accurately detected HPV when precancer was present 96% of the time, which is the same as the clinicians’ collection.
Identifying HPV infections at this stage allows a person to seek follow-up care and preventive interventions to ensure that cervical cancer does not develop.
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PART 3
Delays and Barriers to In-Clinic Cervical Cancer Screening
Our data show that women and people with a cervix delaying or avoiding their cervical cancer screenings is a widespread issue, across demographic groups. We emphasize that this issue of underscreening is not isolated to any one group of women.
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Moreover, the barriers to screening and the negative experiences women associate with in-clinic speculum exams are widely shared and relatable. Many people experienced pain, nervousness, and discomfort with the speculum, and 32% reported having delayed their screening because of this discomfort.
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Unlike common misconceptions suggest, underscreening is not only a challenge for those who are uninsured or low-income.
Almost one-third (32%) of those with some form of insurance report having delayed or avoided their screening.
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Similarly, delaying and avoiding cervical cancer screenings was common across income groups, with over one-third (34%) of all those under the US median household income of $80k having done so.
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PART 4
Preferences and Usability for At-Home Self-Collection Using the Teal Wand
Women and people with a cervix in the SELF-CERV study prefer to do their cervical cancer screening with the Teal Wand, which enables trusted at-home self-collection*. They find screening with the Teal Wand to be comfortable and empowering.
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SELF-CERV study participants also report that the Teal Wand was easy to use and that they felt confident using it.
These are markedly different experiences from the challenges and negative feelings of pain, discomfort, and nervousness they associated with clinician-collected screenings.
Experience Matters
Critical to eradicating cervical cancer, women report that having the Teal Wand as a screening option would make them more likely to engage in routine cervical cancer screening, which is essential for early cancer detection and prevention.
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The SELF-SERV clinical study data clearly shows how experience matters – improving women’s screening experience can improve their screening engagement, which in turn can improve their overall health outcomes.
Hear directly from our study participants
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“I think this is incredibly convenient and effective to do an at home screening. For people who don't live near a clinic, this is a great option.”
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“It is convenient for those patients that are on the go and are unable to get time off, don't have a ride, child care.”
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“I like the privacy. I like that I was not embarrassed by the thought of opening my legs for someone else to do it.”
The Teal Wand not only addressed the widespread challenges with today’s in-clinic speculum-based cervical cancer screening, but it was also a much better experience that would make people more likely to engage in routine screening, rather than putting it off.
We know that there is power in listening to women and people with a cervix when they share their experiences and needs, and designing for those goals.
To learn more about the SELF-CERV Clinical Study and delve into our data, download our Data Report.
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Want to share your thoughts on this data or our report? We would love to hear from you. To share your thoughts, please reach out to us.
Sources:
2 https://seer.cancer.gov/statfacts/html/cervix.html
4 https://progressreport.cancer.gov/detection/cervical_cancer
6 https://www.census.gov/quickfacts/fact/table/US/PST045223
11 https://news.gallup.com/poll/611864/lgbtq-identification.aspx
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