HQ Team
May 12, 2025: The Food and Drug Administration has cleared the first at-home cervical cancer screening test in the US, according to a statement from Teal Health, its maker.
Cervical cancer screenings, commonly referred to as the Pap smear, are critical to a woman’s health, but they are inconvenient and uncomfortable for most women at the moment.
The Teal Wand can screen for cancer, which is “as accurate as going to the doctor’s office, comfortable, and done from home,” according to the statement. It will be available for women aged between 25 and 65 years of age.
The at-home screening includes both the Teal Wand collection kit and an end-to-end telehealth service providing virtual access to Teal medical providers who prescribe the kit, review the results from the lab, and support women throughout their at-home screening experience.
Kits will be available in June, starting in California and expanding nationwide thereafter. Teal is working with insurance providers and plans to have flexible payment options, helping to remove financial concerns and ensuring more women have access to the tests.
Entirely preventable
Cervical cancer is one of the only cancers that is almost entirely preventable with regular screening, yet more than one in four women in the US are behind. It may be because a woman can’t get time off work, is unable to find an available appointment, or avoids the discomfort of an in-clinic exam.
“As a mom and a woman, I get how easy it is to put your 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 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,” she said.
Teal Wand tests a sample for HPV (human papillomavirus), the virus that causes nearly all cervical cancers, using the same HPV test that medical guidelines recommend and providers use in the clinic – the cobas HPV from Roche.
Pap smear to HPV primary screening
Cervical cancer screening has evolved from the Pap smear to HPV primary screening. HPV primary screening demonstrates higher sensitivity compared to the Pap test to identify women who may be at risk of cervical cancer.
The FDA approval was supported by Teal Health’s study, which proved that the tests could detect cervical precancer 96% of the time and that the Teal Wand was a much preferred experience, according to the statement.
The clinical performance and preference for the Teal Wand, alongside 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, it stated.
‘Follow-up’
“Cervical cancer is largely preventable, yet screening rates in the US 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.” Dr Christine Conageski, Principal Investigator in the trial, said.
“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,” she said.
