FDA Grants Breakthrough Device Designation for At-Home Self-Collect Cervical Cancer Screening Device

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The FDA has granted Breakthrough Device Designation for Teal Health’s Teal Wand, a novel at-home self-collect cervical cancer screening device. Breakthrough was awarded following review of Teal Health’s positive midpoint clinical trial data. This will also grant priority status once Teal Health submits their final study data for FDA review.¹

According to Teal Health, the Teal Wand is a proprietary device designed to enable people to easily, comfortably, and confidently collect their own vaginal sample for cervical cancer screening from their home or health clinic, without the need for an invasive exam.

"I am so grateful to the amazing team at Teal, our hardworking PIs and sites, the supportive participants in our study, and the FDA for recognizing the importance of Teal's solution to help close the women's cervical cancer screening gap in the US. The speed of our study shows that if you design for and engage with women to advance women's health, you'll be met with resounding enthusiasm from this group that has been overlooked and under researched for far too long. This study and Breakthrough designation is an important moment for women's health," Kara Egan, CEO and co-founder of Teal Health said in a press release.

The Teal wand was initially tested in a 215-person study. It received positive feedback, with 97% of women saying it was easy or very easy to use, 94% saying they would choose self-collect over the current standard of care with a clinician collecting, and 87% saying they would be more likely to get screened if the Teal Wand were an option.

Teal Health followed this initial study with a nationwide clinical trial titled SELF-CERV (NCT06120205). It is in progress at a number of leading health organizations including Johns Hopkins, Yale University, University of Colorado, University of Wisconsin, and Washington University. With over 600 participants representing people of different races/ethnicities, socioeconomic status, and sexual and gender orientation, the study was designed to validate the performance of the Teal Wand and compare results against a clinician collected sample with a speculum and brush.²

"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. 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," 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 the press release.

The study is months ahead of schedule after it received an overwhelming response from women and people with a cervix.

"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. The clinical performance of the Teal Wand shows promise that an at-home self-collection device is possible in the near term and Teal looks forward to working closely with FDA to expedite this option to eligible women and people with a cervix," Trena Depel, vice president of clinical and regulatory at Teal Health said in the press release.

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™. Press release. May 8, 2024. Accessed May 8, 2024. https://www.prnewswire.com/news-releases/teal-health-completes-clinical-trial-at-record-speed-and-receives-fda-breakthrough-designation-for-its-at-home-cervical-cancer-screening-device-the-teal-wand-302138565.html

2. Teal Health Partners with Leading Health Organizations in a Nationwide Clinical Trial for their Self-Collect Device for Cervical Cancer Screening, the Teal Wand™. Press release. January 9, 2024. Accessed May 8, 2024. https://www.prnewswire.com/news-releases/teal-health-partners-with-leading-health-organizations-in-a-nationwide-clinical-trial-for-their-self-collect-device-for-cervical-cancer-screening-the-teal-wand-302029073.html