The FDA has approved the first at-home cervical cancer screening device, designed to make women feel more comfortable with the process, and help them stay on top of crucial health care screenings.
Teal Health, the company behind the device, completed a 16-site clinical trial that found its at-home collection kit to be just as successful as in-person tests.
With FDA approval, the Teal Wand will be available starting in June in California, with access in more states to follow.
The U.S. Food and Drug Administration (FDA) has officially approved the first at-home cervical cancer screening device.
Teal Health, a women’s health company, has created the Teal Wand. The device allows women to collect a sample for cervical cancer screenings at home, instead of in their doctors’ office, and then they’re able to mail the sample to a lab for analysis.
“As a mom and a woman, I get how easy it is to put your own health last,” Kara Egan, CEO and co-founder of Teal Health, said in a news release.
“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."
Looking at the research
Prior to FDA approval, Teal conducted and completed its SELF-CERV clinical trial. The 16-site clinical trial included over 600 women of varying ages from across the country. The primary goal of the study was to determine if the Teal Wand was as effective as cervical cancer screenings traditionally done in doctors’ offices.
The Teal Wand detected cervical precancer 96% of the time, which is equivalent to in-person doctors’ screenings.
On top of that, the women involved in the study preferred the Teal Wand. Overall, 86% of study participants said they’d be more likely to stay up to date on their cervical cancer screenings with the Teal Wand, while 94% said they’d prefer the at-home test compared to the in-person test.
“As a Principal Investigator in the SELF-CERV trial, I saw firsthand how receptive and excited women were to use the Teal Wand,” Dr. Christine Conageski, associate professor, OB-GYN and Director of the Complex Dysplasia Clinic at the University of Colorado, said in a news release.
“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.”
How it works
The Teal Wand allows women to test for HPV – human papillomavirus – the virus that causes nearly all types of cervical cancers. Teal follows the same recommended medical guidelines technology that’s used in medical offices, which allows for safety and accuracy for at-home testing.
Once you order an at-home kit, Teal will connect you with a telehealth provider for a brief virtual consultation. The provider will go through your past screening history, as well as the process for collecting the sample at home.
The kit comes with everything you’ll need to collect the sample, which women can do in the comfort and privacy of their homes. Then, they mail it off, and the results are analyzed following the American Society for Colposcopy and Cervical Pathology (ASCCP) defined guidelines.
Lastly, the results will be available in your secure Teal account, and a virtual follow-up is scheduled with your Teal health care provider to answer any questions and go over your results.
“Comprehensive screening must go hand in hand with structured, reliable follow-up,” Dr. Conageski said. “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.”
Starting in June, kits will be available on Teal’s website, first available in California, and then rolling out to other parts of the country.
When it comes to payment, Teal is currently working with insurance providers, as well as creating payment plans, to ensure the testing kits are accessible to as many women as possible.
More information is available on Teal’s website here.