The FDA has approved its first at-home collection kit that allows women to screen themselves for human papillomavirus (HPV) and cervical cancer risk by mailing a sample to a lab—where it is analyzed by the same Pap smear test used in clinics.
Developed by Teal Health, the Teal Wand is available with a prescription. It uses a spongelike swab to gather a sample from within the vagina, with no speculum required.
According to a study conducted by the company that included more than 600 participants, samples collected with the Teal Wand were shown to be just as accurate as those taken by a clinician during an office visit—and much more preferable. About 94% of participants said they would opt for self-collection in the future, and 86% said they felt they would be more likely to stay up to date with cervical cancer screening if they could do it at home.
“As a mom and a woman, I get how easy it is to put your own health last,” Teal Health’s co-founder and CEO, Kara Egan, said in a statement. “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.”
The agency’s green light follows two approvals last year for HPV self-collection kits from testmakers BD and Roche—though those needed to be performed within a healthcare clinic.
The Teal Wand will be sold through the company’s website and telehealth platform—starting in June in California, before expanding nationwide—with virtual access to medical providers who will prescribe the kit, review the lab results and offer guidance for at-home screening.
The kit, which previously received a breakthrough designation from the FDA, is designed for women ages 25 to 65 who are considered to have an average risk for cervical cancer.
“Cervical cancer is largely preventable, yet screening rates in the U.S. continue to lag, and the FDA approval of this at-home Teal Wand self-collection device is a critical step forward. It offers an evidence-based way to expand access without compromising accuracy,” said Christine Conageski, M.D., principal investigator of the company’s trial and director of the Complex Dysplasia Clinic at the University of Colorado.
“But access is only part of the solution. Comprehensive screening must go hand in hand with structured, reliable follow-up. That’s why Teal Health’s approach to not only advancing screening technology but also providing education and support to women through every step of their care and follow-up journey is crucial. That’s how we ensure this breakthrough truly closes the gap,” added Conageski, a practicing OB-GYN.