FDA Approves First At-Home Pap Smear Alternative for Cervical Cancer Screening, from Teal Health
The Teal Wand allows women to collect a vaginal sample in the privacy of their home and, according to Teal Health, the test has 96% accuracy for cervical precancer.
The FDA today approved the Teal Wand, an at-home vaginal sample self-collection device for cervical cancer screening that uses the same human papillomavirus (HPV) test recommended by medical guidelines and used in clinical settings, according to manufacturer Teal Health.1
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The prescription device, which will be available for women aged 25–65 at average risk for cervical cancer, allows women to collect their own sample at home without the use of a speculum. After collection, individuals mail the sample to a certified laboratory for processing, according to a Teal Health statement.1
The FDA's approval of the Teal Wand was based on data from the SELF-CERV study, described as the "largest US-based comparative study of its kind." Investigators compared results obtained using vaginal samples collected at home with the Teal Wand against clinician-collected samples using the traditional speculum and brush technique.1 Results showed that samples collected using the Teal Wand detected cervical precancer 96% of the time, matching the performance of samples collected by clinicians. The Teal Wand had a 95% Positive Percent Agreement with clinician-obtained samples and a 90% Negative Percent Agreement.2
The study population (n = 600+) was between age 25 and 65 years, the range recommended by the American Cancer Society for primary HPV screening.2 The majority of the cohort (44%) was aged 30 to 39 years and enrolled for racial/ethnic and socioeconomic diversity. Nearly all study participants (92%) collected a sample in less than 5 minutes and more than one-third (39%) completed the collection in less than 2 minutes.2
Among participants, 86% said they would be more likely to stay up to date with cervical cancer screening if they could self-collect at home, and 94% preferred self-collection if assured of its accuracy.2
Cervical cancer is largely preventable with regular screening, yet more than 1 in 4 women in the US are behind on recommended testing. HPV primary screening, which offers higher sensitivity than the traditional Pap smear, has become the clinical standard, however research shows that screening rates have dropped by approximately 10% in the past decade.3 Further, younger women are being diagnosed with cervical cancer most frequently.4
The Teal screening box is mailed and includes testing materials and conveyance for returning the test via mail to the lab. Results are shared via a secure patient portal, and medical providers are available virtually to discuss results and support with any follow-up care according to established medical guidelines, according to the Teal statement.1
Teal Health plans to launch the Teal Wand in June, beginning in California and expanding nationally. The company is working with insurance providers to facilitate coverage and intends to offer flexible payment options to broaden access.
The FDA’s approval follows its Breakthrough Device Designation for the Teal Wand, reflecting recognition of the device's potential to improve cervical cancer screening adherence. Recent draft guidelines from the United States Preventive Services Task Force (USPSTF) also emphasized the importance of expanding at-home self-collection options.
“The FDA prioritized the review of at-home self-collection, recognizing its potential to increase cervical cancer screening adherence, as emphasized in the recent USPSTF draft guidelines,” Trena Depel, Teal Health vice president of clinical, regulatory, and quality, said in the statement.
“The FDA stayed committed to a timely review, leading to approval of a technology that delivers meaningful performance, benefits, and choice. This isn’t just a win for Teal," Depel emphasized, "it’s a win for every woman who deserves a rigorously tested and FDA reviewed at-home cervical cancer screening option.”
