Teal Health is proud to share the results of our first published clinical study, in the Journal of Lower Genital Tract Disease. This early pilot study — the foundation that supported later, expansive clinical work on the Teal Wand™ — demonstrated that self-collected samples using the Teal Wand achieved high agreement with clinician-collected samples across multiple FDA-approved HPV testing platforms, and were preferred by the vast majority of participants over the traditional in-clinic speculum exam.
The problem 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. Over 20 million women and people with a cervix in the U.S. are behind on their routine screening, and the barriers are well-documented: pain and discomfort during the speculum exam, scheduling and access constraints, past trauma, and negative experiences with clinic-based care. Self-collection has been studied globally for more than two decades as a potential solution, but for at-home self-collection to actually change how women screen, the science had to demonstrate two things: that a self-collected sample could produce clinical results equivalent to a clinician-collected sample, and that women would actually prefer using it. This pilot study set out to answer those questions.
What we studied
This multi-site pilot study enrolled 82 participants across 5 clinical sites in the United States. Each participant used the Teal Wand to self-collect a vaginal sample, followed immediately by a clinician-collected sample obtained with a standard speculum and cervical brush. Both samples from each participant were then tested for high-risk HPV using multiple FDA-approved HPV assays — including the Roche cobas® primary HPV test and the BD OnClarity assay in both PreservCyt and SurePath media. A subset of HPV-positive samples underwent additional dual-stain testing (p16/Ki-67), a technique used clinically to identify samples with a higher likelihood of harboring cervical precancer. Biopsy results, when collected as part of standard care, were also recorded. Participants completed surveys on usability, screening experience, and preferences.
What we found
The data provided strong early evidence that the Teal Wand delivers clinical performance suitable for cervical cancer screening — and that women want to use it:
- High agreement across HPV testing platforms. On the Roche cobas® primary HPV assay, self-collected samples achieved 95% positive percent agreement and 91% negative percent agreement with clinician-collected samples (n=82). On the BD OnClarity assay, agreement was 100% positive percent agreement and 93% negative percent agreement in.
- Strong dual-stain concordance. Dual-stain (p16/Ki-67) results between self- and clinician-collected samples showed 93% overall concordance, and 100% concordance with Roche cobas samples positive for HPV - — an important finding, since dual-stain testing is used clinically to help identify samples most likely to represent true precancer.
- A strong signal that self-collection can increase screening engagement. 89% of participants said they would feel confident using the Teal Wand for screening if they knew the results would be equivalent to a clinician-collected sample. And 86% said they would be more likely to get screened if this at-home option were available to them.
Why it matters
This was the first published clinical evidence that the Teal Wand could perform as a reliable at-home screening device — and it did more than just show equivalence on one test. By demonstrating high agreement across multiple FDA-approved HPV assays and across different sample media, the study established that the Teal Wand's performance wasn't tied to a single lab or a single testing platform, but reflected a robust and versatile collection method. That flexibility matters for real-world clinical implementation, where different labs use different platforms and different media. Just as importantly, the preference and confidence data confirmed early on that women weren't just theoretically open to self-collection — they were meaningfully more likely to actually screen based upon their actual experience using the Teal Wand. Those two findings together — clinical performance across platforms plus real willingness to engage — provided the foundation for advancing to the much larger SELF-CERV pivotal trial that ultimately supported FDA authorization.
Teal Health's role
This pilot study was Teal Health's first peer-reviewed clinical publication and marked the beginning of a rigorous, multi-study research program to establish the Teal Wand™ as a clinically valid and patient-preferred option for cervical cancer screening. It set the stage for the pivotal SELF-CERV trial published in JAMA Network Open, which supported the FDA's May 2025 authorization of the Teal Wand as the first at-home self-collection device for cervical cancer screening in the United States. Since then, Teal-led research has continued to build the evidence base, with sub-analyses focused on women with higher BMI in Archives of Gynecology and Obstetrics, LGBQ+ patients in Cancer Control, cross-population screening experiences in Women's Health Reports, and telehealth-supported results delivery in DIGITAL HEALTH. Together, these studies establish the Teal Wand as clinically equivalent to clinician-collected screening, meaningfully preferred across diverse populations, and supported by an end-to-end digital experience designed to turn screening into action.
We built Teal because cervical cancer prevention should never depend on whether the standard tools were designed with you in mind. This study was the beginning of the evidence — and the beginning of the change.