In a significant advancement for women’s health, the SELF-CERV study has confirmed the Teal Wand as an effective at-home option for cervical cancer screening, offering a preferred alternative to traditional in-person methods.
SAN FRANCISCO /PRNewswire/ — Teal Health, a pioneering company dedicated to the elimination of cervical cancer, announced exciting clinical trial results at the Eurogin International Multidisciplinary HPV Conference. The study demonstrates that samples collected using the Teal Wand™ hold comparable efficacy to those collected by healthcare professionals. This milestone supports Teal Health’s commitment to transforming the cervical cancer screening landscape by providing an accessible, home-based solution that meets the gold standard of clinical testing.
Teal Health Presents Groundbreaking Findings: Teal Wand™ Self-Collected Samples Are on Par with Clinician-Collected Samples
The Teal Wand’s at-home cervical cancer screening device is distinguished by having received the FDA Breakthrough Device Designation, an acknowledgment of its robust clinical data and significance for women’s health. The nationwide study, which included over 600 participants, successfully showed that self-collected samples produced results that align with clinician-collected samples when tested using the Roche Cobas HPV Assay. Leading health authorities, including the USPSTF and the American Cancer Society, endorse HPV testing as the most precise cervical cancer screening method, boasting a sensitivity rate of 95%, far surpassing the 55% sensitivity of traditional Pap smears. Unlike Pap smears, HPV samples can be conveniently collected by the individual.
Key Findings from the SELF-CERV Study
- Teal Wand’s clinical sensitivity rates at 96%, consistent with clinician-collected sample results, which also stand at 96%, reflecting its effectiveness in identifying cases of cervical cancer or precancer.
- Agreement between self-collected samples and clinician-collected samples is 95%, exceeding the established equivalency threshold of 87%.
- Usability rates are impressively high: 99% of participants reported no difficulties, and 92% completed their collection in less than five minutes, while 98% of self-collected samples were determined to be valid for analysis, showcasing a strong understanding and capability among users for self-collection.
The study further revealed a remarkable preference among women for at-home screening options. A substantial 94% of the participants stated they would choose Teal Health’s self-collection method if it provided comparable accuracy to clinician-collected samples, and 86% expressed they would be more likely to engage in routine screenings if an at-home alternative was available. This highlights the urgent demand for diverse screening choices. Teal Health also emphasized inclusivity within the SELF-CERV study, ensuring that clinical trial participants represented a broad spectrum of the US population in terms of race, ethnicity, gender, income, and geography.
Despite current HPV screening methods effectively detecting precancerous conditions with up to 95% sensitivity, the conventional in-office screenings have led to nearly one-third of women missing out on regular screenings. Unlike other cancer screenings that saw rebounds post-COVID-19, cervical cancer screening rates have stagnated, with challenges such as appointment accessibility, time limitations, and discomfort during the speculum exam acting as barriers for many women.
Teal Health’s at-home solution, which integrates a telehealth platform with the Teal Wand, addresses these issues directly, offering a comfortable, accessible, and clinically validated alternative that could significantly enhance participation in screenings for this nearly preventable disease.
The Eurogin Conference is a prominent global gathering for leading experts in HPV detection, prevention, and treatment. By sharing its important SELF-CERV study findings at this prestigious event, Teal Health contributes to an international dialogue aimed at eradicating cervical cancer and promoting wider access to lifesaving screening technologies.
“These results bring us closer to providing women in the US with a scientifically validated, at-home cervical cancer screening option, which is currently undergoing thorough FDA review,” said Kara Egan, CEO & Co-founder of Teal Health. “We believe this innovation could fundamentally shift preventive care, eliminate unnecessary barriers, and ultimately save lives.”
For additional information about Teal Health, please visit getteal.com.
About Teal Health
Teal Health is committed to enhancing the healthcare experience for women, starting with cervical cancer screenings. By allowing women to conduct these screenings from the comfort of their homes, while providing telehealth follow-ups, Teal Health aims to improve access to this vital cancer screening. Teal Health is a proud member of the Cervical Cancer Roundtable, a collaboration between the American Cancer Society and the Biden Cancer Moonshot aimed at eliminating cervical cancer as a public health concern in the US. Discover more at www.getteal.com.
