Teal Health, the cervical cancer screening startup backed by Serena Williams, has been granted Breakthrough Device status by the U.S. Food and Drug Administration for its innovative, at-home screening wand.
The status was awarded following promising mid-point data from the Teal Wand’s first, nationwide clinical trial, and puts it on track for priority approval once the company submits its final results for review.
Designed for a wide range of bodies and health literacy levels, the device measures less than an inch in diameter and would enable users to self-collect vagical cells at home in under five minutes. They’d then mail their sample to a laboratory for primary screening of high-risk HPV, the single most important risk factor in developing cervical cancer.
The privacy and added comfort that the wand provides could make a world of difference for countless people. In an initial study by Teal Health preceding the clinical trial’s commencement late last year, 94% of women said they would choose self-collect over the current standard of care, and 87% said they would be more likely to get screened if the Teal Wand were an option.
“The speed of our study shows that if you design for and engage with women to advance women’s health, you’ll be met with resounding enthusiasm from this group that has been overlooked and under researched for far too long,” Teal Health CEO and co-founder Kara Egan said in a statement shared with Nice News. “This study and Breakthrough designation is an important moment for women’s health.”
Currently, 1 in 4 women in the U.S. are not up to date on their cervical cancer screening. Though the disease is preventable, and when caught early has a five-year relative survival rate of 91%, it’s consistently the second-leading cause of cancer death among women aged 20-39.
Screenings often require a pap smear, which is performed with a speculum and can be a source of fear, pain, and embarrassment, leading some women to avoid the procedure. Other barriers include lack of time, access, and information.
Per a press release from the startup, “Studies show that women of all races and socioeconomic levels experience these barriers, with Native American, Black, and Hispanic women resulting in higher underscreened rates.”
With the wand, users would avoid invasive exams or having to take off work to visit a clinic. Their screening results would appear on a patient portal, where they’d also be able to connect virtually with a health provider who could refer them for any follow-up care.
“Self-collection will increase access and is a much preferred alternative [to in-person exams],” the release states. “It has already been adopted in other countries, including Australia, which increased their screening engagement 50 fold within its first year and is now on track to eliminate cervical cancer as a public health concern by 2035.”
Join the waitlist for the Teal Wand, and click here to search for a traditional screening program near you.
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