FDA Clears First At-Home HPV and Cervical Cancer Screening Kit

The U.S. Food and Drug Administration has approved the first at-home collection kit designed to allow women to screen themselves for human papillomavirus (HPV) and assess cervical cancer risk using a mailed-in sample. The device, developed by Teal Health and known as the Teal Wand, enables self-collection without a speculum and is available by prescription.
The Teal Wand uses a spongelike swab to collect a sample from within the vagina. Once mailed to a laboratory, the sample is analyzed using the same Pap smear test employed in clinical settings. According to a study conducted by Teal Health involving more than 600 participants, the samples collected with the Teal Wand were found to be as accurate as those collected by clinicians during in-office visits.

Participant feedback from the study indicated a high level of preference for at-home screening. Approximately 94% of participants said they would choose self-collection in the future, while 86% stated they believed they would be more likely to stay current with cervical cancer screenings if they could complete them at home.
Teal Health’s co-founder and CEO, Kara Egan, emphasized the importance of accessibility and convenience, particularly for women managing multiple responsibilities. “That’s why this FDA approval means so much; it’s not just about an innovative new product, it’s about finally giving women an option that makes sense for their lives—something that can be done quickly and comfortably at home,” she said in a statement.
This FDA decision follows prior approvals for HPV self-collection kits by BD and Roche in 2023. However, those earlier kits required sample collection within a healthcare clinic. In contrast, the Teal Wand is intended specifically for at-home use.
The product will initially be available through Teal Health’s website and telehealth platform starting in June, beginning in California, before becoming available nationwide. Patients will have virtual access to licensed medical providers who will prescribe the kit, evaluate the results, and offer support throughout the screening process.

The Teal Wand is intended for women aged 25 to 65 who are considered to be at average risk for cervical cancer. It previously received a breakthrough designation from the FDA.
Christine Conageski, M.D., principal investigator of the Teal Health trial and director of the Complex Dysplasia Clinic at the University of Colorado, noted that improving access is an essential step in addressing low screening rates. “The FDA approval of this at-home Teal Wand self-collection device is a critical step forward,” she said. “It offers an evidence-based way to expand access without compromising accuracy.”