FDA Grants Breakthrough Device Designation to At-Home Cervical Cancer Screening Test

The FDA has granted a breakthrough device designation to Teal Wand, a novel at-home screening test for cervical cancer, according to an announcement from Teal Health.¹

Teal Wand allows for at-home collection of a vaginal sample, which users then mail to a laboratory. The sample is then assessed using an FDA-approved diagnostic test for high-risk human papillomavirus (HPV). Results are delivered through a patient portal, which also provides users with direct access to women’s health providers and assistance in scheduling follow-up care, if necessary.

“I am so grateful to the amazing team at Teal [Health], our hardworking primary investigators and sites, the supportive participants in our study, and the FDA for recognizing the importance of Teal [Health’s] solution to help close the women’s cervical cancer screening gap in the United States,” Kara Egan, chief executive officer and co-founder of Teal Health, stated in a news release.

Teal Wand was initially tested in a study that included 215 women. Results showed that 97% of participants said the device was easy or very easy to use; 94% said they would elect for the at-home test vs clinician testing; and 87% said they would be more likely to undergo screening for cervical cancer if Teal Wand was an option.

The company subsequently initiated the SELF-CERV trial (NCT06120205), which completed enrollment in May. The study is intended to validate Teal Wand and compare results with a clinician-collected sample.

“The Teal Wand and self-collection really resonated with our patients, and they were excited to be a part of the SELF-CERV trial. We saw upwards of an 80% enrollment rate, which more than met our expectations,” lead SELF-CERV enroller Clair Kaplan, MSN/APRN, MHS, MT(ASCP), director of Clinical Research and principal investigator at Planned Parenthood of Southern New England, said in a news release. “I am honored to have been part of the efforts to advance cervical cancer screening and create more options for patients to get the care they need.”

The study invited female participants who were 25 to 65 years of age with an intact cervix for the trial’s general population.² In the enriched population, women also needed to meet one of the following criteria: prior diagnosis of high-risk HPV within the previous 6 months; a positive cervical Pap cytology result within the previous 6 months; and/or presentation for colposcopy, loop electrosurgical excision procedure, or excisional intervention.

Women were excluded if they underwent partial or complete hysterectomy, including removal of the cervix; underwent any form of cervical tissue alteration or surgery within the previous 5 months; were pregnant; reported or experienced menstrual bleeding; or were participating in another clinical study for an investigational device, drug, or biologic that could interfere with the results of this SELF-CERV, in the opinion of the investigator.

All participants used Teal Wand to self-collect vaginal cells before filling out a usability survey, as well as a satisfaction-and-needs survey. Patients then had a vaginal sample collected by a clinician. Notably, participants served as their own comparators.

The primary end points of the study were the detection of high-risk HPV in the self- and clinician-collected samples, as well as safety.

“FDA’s recognition of the Teal Wand as a breakthrough device acknowledges the important public health benefit that self-collection for cervical cancer screening can have on those who are rarely screened or who do not participate in clinician-based screening for cervical cancer,” Trena Depel, vice president of Clinical and Regulatory at Teal Health, added in a news release.¹

References

1. Teal Health completes clinical trial at record speed and receives FDA breakthrough designation for its at-home cervical cancer screening device, the Teal Wand. News release. Teal Health. May 8, 2024. Accessed May 9, 2024. https://www.getteal.com/news/teal-health-completes-clinical-trial-at-record-speed-and-receives-fda-breakthrough-designation-for-its-at-home-cervical-cancer-screening-device-the-teal-wandtm
2. SELF-CERV pivotal study: self-collection for cervical cancer screening. ClinicalTrials.gov. Updated March 19, 2024. Accessed May 9, 2024. https://clinicaltrials.gov/study/NCT06120205