FDA Approves First At-Home Test for Cervical Cancer Screenings

Pap smears are a vital tool for preventing cervical cancer because they can detect cell abnormalities before they become cancerous. Unfortunately, systematic barriers or a lack of comfort with the procedure means many people aren’t receiving it. But on Friday, the FDA approved the first at-home test for cervical cancer screenings that is a less invasive and potentially more accessible alternative to pap smears.

The newly FDA-approved test was developed by San Francisco-based startup Teal Health. Like traditional pap smears, Teal Health tests for the human papillomavirus or HPV, which causes virtually all cervical cancers. However, it’s test, the Teal Wand, only requires a vaginal swab with a spongelike tool instead of inserting a speculum to scrape cells from the cervix.

In a statement, Kara Egan, CEO and co-founder of Teal Health, said that the approval isn’t “just about an innovative 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,” Egan continued.

In the United States, about 11,500 new cases of cervical cancer are diagnosed each year, and 4,000 people will die of it. However, cervical cancer could be “eradicate[d] in our lifetime,” Dr. Alexi Wright, the director of gynecologic oncology outcomes research at the Dana-Farber Cancer Institute, told the New York Times. “We have the tools to do it. We just don’t have comprehensive HPV vaccination or cervical cancer screening, and often can’t reach the people who are at highest risk.”

According to the American Cancer Society, cervical cancer deaths in the U.S. have dropped by over half since the mid-1970s, although it has leveled off recently. One 2022 study found that 23% of people were behind on their screenings in 2019 compared to 14% in 2005. Although reasons vary, one study found that lack of insurance and cost were common factors. In addition, cervical cancer rates are 25% higher in rural areas, and the death rate is 42% higher, likely due to a lack of resources and health care providers. For some, discomfort is also a big barrier. In 2023, many participants in a Michigan Medicine study said that at-home kits “provide a comfortable, convenient, and flexible choice without trauma.”

At-home screenings are effective alternatives for closing the screening gap. One study found that mailing kits to people overdue for cervical cancer screenings saw a 50% increase compared to offering usual care alone. In addition, they are just as accurate as clinical tests. (Teal Health also has a SELF-CERV study.)

Teal Health plans to make kits available next month, starting in California. The company is also coordinating with major insurance providers in the hope of covering costs. In addition to requesting tests through Teal Health’s platform, people can coordinate follow-up care through it if necessary.