Teal Health is proud to share new peer-reviewed findings from our SELF-CERV pivotal trial, published in Archives of Gynecology and Obstetrics. The study demonstrates that the Teal Wand™ — the first FDA-authorized at-home self-collection device for cervical cancer screening — performs equally well across all body sizes, and is meaningfully preferred by women with higher BMI, a population that has long been underserved by traditional in-clinic screening.
The disparity we set out to address
Cervical cancer is one of the most preventable cancers in existence — but only if people are actually able to get screened. For women with higher BMI, the in-clinic speculum exam can be a real barrier. Roughly 4 in 10 U.S. women have a BMI of 30 or higher, and women with a BMI of 35 or higher are 25–40% less likely to be up to date on cervical cancer screening than women with lower BMI. The reasons are well-documented: speculum exams can be physically uncomfortable or technically difficult at higher body weights, both patients and providers report avoiding the exam due to weight stigma, and these dynamics compound over time into delayed care. The result is later diagnosis and worse outcomes in a population that already faces inequities elsewhere in the healthcare system.
What we studied
This study is a sub-analysis of SELF-CERV, the largest U.S. clinical trial of at-home cervical cancer self-collection. Conducted across 16 clinical sites nationwide, the trial enrolled 609 participants aged 25 to 65, including a substantial proportion of participants with BMI in the overweight, obese, and severely obese categories. Each participant first used the Teal Wand to collect their own vaginal sample in a simulated at-home environment, followed immediately by a clinician-collected sample using a standard speculum and cervical brush. Both samples were tested for high-risk HPV using the FDA-approved Roche cobas® assay. Participants also completed surveys on prior screening experiences, usability, and preferences. The research team then analyzed clinical performance and patient experience across BMI categories.
What we found
The data tell a clear story:
- Clinical accuracy holds up across body sizes. The Teal Wand performed equivalently to clinician-collected samples for HPV detection in every BMI category — including the highest BMI groups, where in-clinic exams are most difficult. Detection of high-grade cervical precancer (CIN2+) was preserved across all body sizes.
- Higher-BMI patients have worse experiences with traditional screening. Participants with higher BMI were more likely to report pain, discomfort, and aversion during prior speculum-based exams, and were more likely to have delayed or avoided screening as a result.
- Self-collection changes the experience. Participants with higher BMI who used the Teal Wand reported greater comfort, ease, and a clear preference for at-home screening over the in-clinic exam.
- Strong usability across all groups. The Teal Wand was rated as easy to use and acceptable across BMI categories, demonstrating that a thoughtfully designed at-home option works for everyone.
- A path to better engagement. A meaningful majority of higher-BMI participants said they would be more likely to stay current on cervical cancer screening if at-home collection were available — addressing the engagement gap directly at its source.
Why it matters
Cervical cancer screening only prevents cancer if people actually get screened. For women with higher BMI, the standard speculum exam has too often been a barrier rather than a bridge to care — and that barrier has measurable consequences in delayed diagnosis and worse outcomes. This study provides direct, peer-reviewed evidence that an FDA-authorized at-home option performs accurately across body sizes and is the option many higher-BMI patients have been waiting for. Broader adoption has the potential to meaningfully close a long-standing, well-documented screening gap that affects roughly 40% of U.S. women.
Teal Health's role
Teal Health designed the Teal Wand™ specifically to perform well across diverse bodies — recognizing that screening tools built around a one-size-fits-all model leave too many people behind. This study is part of a growing body of peer-reviewed Teal-led research, alongside our pivotal SELF-CERV results published in JAMA Network Open and our sub-analysis on screening experiences for LGBQ+ patients published in Cancer Control. Together, these studies establish the Teal Wand as both clinically equivalent to clinician-collected screening and uniquely suited to closing screening gaps for the populations who need a better option most.
We built Teal because cervical cancer prevention should never depend on whether the standard tools were designed with you in mind. This study is one more piece of evidence that, with the right tools, they can be.