Teal Health is proud to share the foundational results of our pivotal SELF-CERV clinical trial, published in JAMA Network Open and the basis for FDA authorization of the Teal Wand™ — the first at-home cervical cancer screening device in the United States. The study demonstrates that samples collected by patients at home are clinically equivalent to those collected by clinicians in the office, while being meaningfully easier and more comfortable for the people doing the screening.
The problem we set out to solve
Cervical cancer is one of the most preventable cancers we know of — yet roughly 1 in 4 people with a cervix in the U.S. are behind on routine screening, and more than 4,000 women die from cervical cancer every year. The barriers are well-documented: pain and discomfort during the speculum exam, scheduling and time constraints, lack of access to in-clinic care, prior negative experiences, and the practical reality that an in-office Pap simply doesn't fit easily into many people's lives. To close that gap, screening needs to meet people where they are — including in the privacy and comfort of their own homes — without compromising on clinical accuracy.
What we studied
SELF-CERV is the first large U.S. clinical trial evaluating at-home cervical cancer self-collection. It was a prospective, multi-center, method-comparison study conducted at 16 clinical sites across the country, enrolling 609 participants aged 25 to 65 — a group representative of the U.S. screening-eligible population in race, age, and socioeconomic background. 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 — the same test used in clinical practice. Participants also completed surveys on usability, prior screening experiences, and preferences. The study was registered on ClinicalTrials.gov (NCT06120205).
What we found
The data demonstrated that at-home self-collection delivers clinical performance equivalent to the in-office standard of care:
- High agreement with clinician-collected samples. The Teal Wand achieved 95.2% positive percent agreement (PPA) for detection of high-risk HPV when compared with paired clinician-collected samples — significantly exceeding the FDA's 87% clinical endpoint for equivalency.
- Equivalent detection of cervical precancer. Clinical sensitivity for high-grade cervical dysplasia (CIN2+) was 95.8%, matching clinician-collected sample performance with a relative sensitivity of 1.00. For CIN3+, sensitivity was 96.6%.
- Reliable across HPV genotypes. Agreement for the highest-risk HPV-16 and HPV-18 genotypes was 95.8%.
- Strong usability. 92.3% of participants found the instructions easy or very easy to follow, and the rate of invalid samples was just 2.3% — a clinically acceptable level for a screening test.
- A clear preference for self-collection. 93% of participants said they would choose at-home self-collection if they knew the results would be equivalent to clinician-collected samples — and the data confirm that they are.
- Safe. The device and procedure were safe across all participants, with no serious or unexpected adverse events.
Why it matters
These results provided the clinical foundation for the FDA's authorization of the Teal Wand in May 2025 — making it the first at-home self-collection device approved for cervical cancer screening in the United States. The implications go well beyond regulatory milestones: cervical cancer screening using self-collected samples has since been incorporated into draft USPSTF cervical cancer screening guidelines, ACS (American Cancer Society), ACOG (American College of Obstetricians and Gynecologists) and HRSA Women’s Preventive Services Guidelines with strong evidence that increased screening engagement is most effectively achieved when at-home collection is an option. With an estimated 21 million women in the U.S. currently under- or unscreened, a clinically validated at-home option has the potential to reach the people the current system has been missing — without asking them to compromise on accuracy.
Teal Health's role
Teal Health designed the Teal Wand™ specifically for at-home use, with a form factor optimized for comfort, usability, and clinical performance across different bodies and life stages. SELF-CERV is the foundational trial behind the Teal Wand and supported its FDA authorization. It anchors a growing body of peer-reviewed Teal-led research that includes sub-analyses on screening among women with higher BMI (Archives of Gynecology and Obstetrics) and on screening experiences for LGBQ+ patients (Cancer Control) — each demonstrating that at-home self-collection isn't just an alternative to clinic-based care, but a clinically validated tool for closing real, measurable gaps in cervical cancer prevention.
You can see more information about the trial, results, and demographics in our SELF-CERV study report.
We built Teal because cervical cancer is preventable — but only if people actually get screened. SELF-CERV is the proof that they can, accurately and comfortably, from home.