Teal Wand Approved as First At-Home HPV Test for Cervical Cancer Screening

The FDA has approved Teal Wand, the first and only at-home self-collection device for cervical cancer screening in the US.

The tool offers a comfortable and convenient alternative to traditional in-clinic Pap smears. It aims to increase screening accessibility and adherence among women aged 25 to 65 who are at average risk for cervical cancer.

The approval was granted to Teal Health, a women’s health company focused on eliminating cervical cancer.

Teal Wand is designed to allow women to collect their own vaginal samples at home without the need for a speculum, a common source of discomfort in traditional screenings.

The samples are tested for HPV (human papillomavirus), the virus that causes nearly all cervical cancers. Cervical cancer screening has advanced from traditional Pap smears to HPV primary screening, which offers greater sensitivity in detecting women at risk.

The collected sample is then mailed to a certified laboratory for analysis using the same FDA-approved HPV testing methods employed in clinical settings. Namely, Roche’s cobas HPV, which is recommended by medical guidelines. This ensures that the at-home test maintains the accuracy and reliability of in-clinic screenings.

Related: BD’s Cervical Cancer Screening Survey Finds Women Skipping OB/GYN Exams

Teal Health says the Teal Wand simply offers a different method of sample collection. This means women can now use the same clinically validated test offered in doctors’ offices — delivering the same accuracy, while collecting their sample privately at home.

The at-home screening offering combines the Teal Wand collection kit with a comprehensive telehealth service, giving women virtual access to Teal’s medical providers who prescribe the test, interpret lab results and offer ongoing support throughout the process.

Barriers to Cervical Cancer Screening

Cervical cancer is one of the few cancers that is almost completely preventable through regular screening — yet more than 25% of women in the US are not up to date with their screenings.

A recent study commissioned by medtech giant BD revealed that 72% of women in the US delayed their OB/GYN visits. About half of the surveyed women cited discomfort and scheduling difficulties as key reasons for delays.

Barriers include discomfort with in-clinic exams, limited time off work and difficulty accessing appointments.

By providing a private, convenient and accurate at-home screening option, Teal Health says Teal Wand aims to overcome these obstacles and encourage more women to seek regular cervical cancer screening.

The company says the device offers a compassionate, science-backed solution that empowers women to take charge of their health — on their own terms.

“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, 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. 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.”

Clinical Data Supporting the Teal Wand

The FDA’s approval was supported by the SELF-CERV study, the largest US-based clinical trial of its kind, according to Teal Health. Results from the study demonstrated that self-collected samples using the Teal Wand are as effective as clinician-collected samples in detecting cervical precancer, 96% of the time, and that the Teal Wand is a highly preferable experience.

The study also highlighted a strong preference among participants for the at-home method, with 94% indicating they would choose self-collection if assured of its accuracy.

Moreover, 86% of participants said they would be more likely to stay up to date with cervical cancer screening if they could do it at home.

Teal Health says the clinical performance and preference for the Teal Wand, coupled with Teal’s comprehensive telehealth service, “highlight the potential of at-home self-collection to expand access to high-quality cervical cancer screening and improve outcomes.”

Teal Wand Market Launch

The Teal Wand will be available soon by prescription on Teal Health’s website, getteal.com, and through Teal Health’s telehealth services, ensuring that users receive appropriate guidance and support throughout the screening process.

Teal Health plans to launch the Teal Wand in California starting in June, with a nationwide rollout to follow.

Efforts are underway to work with major insurance providers to cover the cost of the test, making it accessible to a broader population.

The FDA granted similar approvals last year to BD and Roche for their HPV self-collection kits. However, those tests must still be administered within a clinical setting.

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