Teal Health has received FDA approval for the Teal Wand, the first and only at-home self-collection device for cervical cancer screening in the United States. The device is designed to detect human papillomavirus (HPV), the virus that causes nearly all cervical cancers, and has been proven to detect cervical precancer 96% of the time, equivalent to clinician-collection using a speculum.
Targeted at individuals aged 25-65 at average risk, the at-home screening kit includes both the collection device and access to an end-to-end telehealth service with Teal medical providers who support users throughout their screening experience.
“As a mom and a woman, I get how easy it is to put your own health last,” said Kara Egan, CEO and Co-Founder of Teal Health. “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 actually makes sense for their lives – something that can be done quickly and comfortably at home. Because when we make care easier to get, we help women stay healthy, for themselves and for the people who rely on them every day.”
According to the company, more than one in four women in the U.S. are behind on cervical cancer screening due to various barriers including lack of time, inability to find appointments, or discomfort with in-clinic exams.
The FDA approval was supported by the SELF-CERV study, the largest U.S.-based comparative study of its kind, according to the company. The study confirmed that self-collected samples using the Teal Wand have the same performance as clinician-collected samples. According to Teal Health, 86% of study participants said they would be more likely to stay up to date with cervical cancer screening if they could do it at home, and 94% said they would prefer to self-collect with the Teal Wand knowing it was accurate.
“The FDA prioritized the review of at-home self-sampling, recognizing its potential to increase cervical cancer screening adherence, as emphasized in the recent USPSTF draft guidelines,” said Trena Depel, Teal Health’s VP of Clinical, Regulatory, and Quality. “After awarding the Teal Wand Breakthrough Device Designation, the FDA stayed committed to a timely review, leading to approval of a technology that delivers meaningful performance, benefits, and choice.”
The company states that kits will begin shipping in June, starting in California before expanding throughout the US. Teal Health is working with major insurance providers and plans to offer flexible payment options to improve accessibility. Teal Health’s telehealth platform also ensures users have access to dedicated providers who support them with guidance, results, referrals, and follow-up care—addressing a gap where nearly 75 percent of women with abnormal results reportedly don’t take timely action due to lack of support or clear next steps.
