SAN FRANCISCO, May 19, 2025 /PRNewswire/ — Following its recent FDA approval, Teal Health® announced the publication of its multi-center pivotal SELF-CERV study in JAMA Network Open. The study supported the recent U.S. Food and Drug Administration (FDA) approval of the Teal Wand™, the first and only FDA-approved, prescription device for at-home self-collection of vaginal samples for cervical cancer screening using the highly sensitive primary HPV test.
The SELF-CERV study enrolled 609 participants aged 25 to 65 across 16 clinical sites throughout the United States. Self-collected samples were compared to clinician-collected samples from the same participant and were evaluated for agreement. Both samples were tested using the FDA-approved cobas® HPV from Roche, which is approved for cervical cancer screening. The study was representative of the US population in terms of race, age, and socioeconomic diversity.
Key study results showed that the Teal Wand was highly effective for sample collection with a 95% positive agreement for detection of high-risk HPV, significantly exceeding the clinical endpoint of 87%, and 96% sensitivity for CIN2+ (precancer), which matched clinician-collected samples (relative sensitivity = 1.00). Sensitivity measures a cancer screen’s ability to predict disease when present, maximizing true positives and minimizing false negatives. These results show that self-collection at home matches the clinical accuracy of the standard screening. Other reported outcomes include high user comprehension and strong patient preference, with over 86% reporting a greater likelihood to stay up to date with an at-home self-collection option.
Cervical cancer screening using self-collected samples was recently included in the USPSTF’s draft cervical cancer screening guidelines, with evidence that increased screening is most strongly supported with self-collection at home. With FDA approval, the Teal Wand has the potential to address a significant screening gap in the US, with an estimated 21 million women under- or unscreened for cervical cancer, leading to an annual death rate of over 4,000, and offer a choice that does not compromise accuracy and is preferred by women.
About Teal Health
Teal Health is a woman-led company on a mission to improve women’s healthcare experiences, starting with the first FDA-approved at-home cervical cancer screening. By creating the option for a woman to screen for cervical cancer from the comfort of home and providing virtual support along the way, and personalized follow-up when needed, Teal can increase access to this life-saving cancer screening. Teal Health is a member of the Cervical Cancer Roundtable, a joint collaboration between the American Cancer Society and the Biden Cancer Moonshot, a coalition of industry leaders with the goal of eliminating cervical cancer as a public health concern in the US. To learn more, visit www.getteal.com.
SOURCE Teal Health