Teal Health has announced the results of its SELF-CERV study, the largest nationwide comparative study in the U.S. examining self-collected cervical cancer screening samples, demonstrating that its Teal Wand device delivers results equivalent to clinician-collected samples.
The study, involving over 600 participants, found that samples collected using the Teal Wand at home matched the performance of traditional in-office screening when tested on the Roche Cobas HPV Assay. Both methods showed a clinical sensitivity of 96%, with self-collected sample agreement of 95% with clinician-collected samples, exceeding the 87% threshold for equivalency.
“With these results, we are one step closer to offering US women a scientifically validated, at-home cervical cancer screening option which is currently undergoing rigorous FDA review,” said Kara Egan, CEO & Co-founder of Teal Health. “We believe this innovation has the power to transform preventive care, eliminate unnecessary barriers, and ultimately save lives.”
The Teal Health device has received FDA Breakthrough Device Designation, recognizing both its clinical performance and potential public health impact. The company presented its findings at the Eurogin International Multidisciplinary HPV Conference.
The study revealed strong user acceptance of the self-collection device:
- 99% of participants reported no difficulty using the device
- 98% of users successfully collected valid samples for analysis
- 92% completed collection in under 5 minutes
- 94% indicated they would choose Teal Health’s self-collection option if they knew it provided the same accuracy as a clinician-collected sample
Current statistics show that nearly one in three women fall behind on cervical cancer screenings, with rates remaining stagnant even after the COVID-19 pandemic when other cancer screening rates rebounded. Barriers such as appointment availability, time constraints, and discomfort with the speculum exam deter many women from routine care.
Teal Health’s approach could significantly impact screening participation rates for cervical cancer, which is nearly 100% preventable with proper screening and follow-up. The company’s telehealth platform, coupled with the Teal Wand, offers an alternative that addresses common barriers to traditional screening methods.
Leading medical guidelines, including those from the U.S. Preventive Services Task Force (USPSTF) and the American Cancer Society (ACS), recognize HPV testing as the most sensitive cervical cancer screening test at 95% sensitivity, exceeding the traditional Pap smear’s 55% sensitivity. While Pap smears can only be collected by a clinician, HPV samples can be self-collected.
The SELF-CERV study prioritized inclusion, ensuring participants represented the U.S. population across race, ethnicity, gender, income, and geography. The study found that 86% of participants reported they would be more likely to stay up-to-date with routine screening if an at-home option were available.
