The U.S. Food and Drug Administration (FDA) has approved the Teal Wand™, making it the first and only FDA-approved prescription device for at-home self-collection of vaginal samples for cervical cancer screening using primary HPV testing. This milestone approval follows the publication of Teal Health's multi-center pivotal SELF-CERV study in JAMA Network Open, which demonstrated that self-collected samples matched the clinical accuracy of standard screening methods.
The SELF-CERV study enrolled 609 participants aged 25 to 65 across 16 clinical sites throughout the United States. The study design compared self-collected samples using the Teal Wand to clinician-collected samples from the same participant. Both samples were analyzed using Roche's FDA-approved cobas® HPV test, which is authorized for primary cervical cancer screening.
Study Results Demonstrate Clinical Equivalence
The study results showed that the Teal Wand exceeded clinical endpoints for effectiveness. Self-collected samples achieved 95% positive agreement for detection of high-risk HPV, significantly surpassing the predetermined clinical endpoint of 87%. Additionally, the device demonstrated 96% sensitivity for CIN2+ (precancerous lesions), which was equivalent to clinician-collected samples with a relative sensitivity of 1.00.
Dr. Rebecca Perkins, a gynecologic oncologist and cervical cancer screening expert not affiliated with the study, noted, "Sensitivity is a critical measure of a cancer screening test's ability to predict disease when present. These results indicate that self-collection at home can match the clinical accuracy we see in traditional in-office screening methods."
The study population was representative of the US demographic landscape in terms of race, age, and socioeconomic diversity, strengthening the generalizability of the findings.
Patient Preference and Usability
Beyond clinical accuracy, the SELF-CERV study revealed strong patient preference for at-home testing. Over 86% of participants reported they would be more likely to stay up to date with cervical cancer screening if an at-home self-collection option were available. The study also documented high user comprehension of the device instructions and collection process.
"The user experience data is particularly encouraging," said Kara Egan, CEO of Teal Health. "We designed the Teal Wand with women's needs and preferences in mind, aiming to remove barriers to this essential preventive health measure."
Addressing a Critical Screening Gap
The FDA approval of the Teal Wand comes at a critical time. An estimated 21 million women in the United States are under- or unscreened for cervical cancer, contributing to over 4,000 deaths annually from a largely preventable disease.
The U.S. Preventive Services Task Force (USPSTF) recently included self-collected samples in their draft cervical cancer screening guidelines, noting that increased screening rates are most strongly supported with at-home self-collection options.
"The evidence clearly shows that giving women choices increases screening rates," explained Jessica Mays, Chief Medical Officer at Teal Health. "With the Teal Wand, we're offering an option that doesn't compromise on accuracy while addressing many of the barriers that keep women from getting screened."
Implementation and Access
As a prescription device, the Teal Wand will be available through healthcare providers. Samples collected using the device will be processed using the FDA-approved cobas® HPV test from Roche, ensuring integration with existing laboratory workflows and reporting systems.
Teal Health, a woman-led company, is working to establish partnerships with healthcare systems, insurers, and women's health organizations to maximize access to this new screening option. The company is also a member of the Cervical Cancer Roundtable, a joint collaboration between the American Cancer Society and the Biden Cancer Moonshot initiative, which aims to eliminate cervical cancer as a public health concern in the United States.
Future Implications
The approval of the Teal Wand represents a significant advancement in cervical cancer prevention strategies. By providing an at-home option that maintains clinical accuracy while addressing patient preferences, this technology has the potential to increase screening rates among underserved and hard-to-reach populations.
Public health experts suggest that innovations like the Teal Wand could play a crucial role in achieving the World Health Organization's goal of eliminating cervical cancer globally. For the United States specifically, increasing screening rates among the 21 million under- or unscreened women could significantly reduce the incidence and mortality of cervical cancer in the coming decades.
