FDA approves Startup Teal Health's At-home Cervical Cancer Screening

• On May 9, 2025, Food and Drug Administration approved startup Teal Health developed first-ever at-home test for cervical cancer screening
• The startup started developing the prototype over five years ago

The first-ever at-home test for cervical cancer screening has been approved by the Food and Drug Administration on May 9, 2025. The test was developed by startup Teal Health, based in San Francisco.

Over five years ago, the startup started developing the prototype for its Teal Wand. They were working with the concept of making cervical cancer screening more accessible through telehealth in addition to a test that could be self-administered at home rather than going to a doctor for the same.

In a statement, Teal Health CEO Kara Egan said, “The pandemic showed everyone that telehealth is a thing that is preferred … and made it easier to get care for most Americans. Covid also demonstrated at-home testing was a thing that people could handle and really understand.”

Test involves a teal wand that works like a tampon applicator attached with a large swab that the users can insert into themselves for collecting the sample for testing. In addition, the tool has been designated as a breakthrough device by FDA, after the clinical trial results of the firm that showed the self-administered test’s precision was comparable with an in-office screening which is performed by a clinician, with a 96% accuracy rate.

Egan added, “This is about increasing access to care and making sure we have more options to get that care.”

Furthermore, Principal in Deloitte's life sciences and health-care practice Jen Radin said, “From 2023 to 2024 femtech saw 41% growth, outpacing overall health tech, which grew only 10%.”

FemHealth Ventures managing partner Maneesha Ghiya says, “Many more people are thinking about women's health more broadly and supporting these types of innovations — and that includes from the large, established players like medtech, pharma, biotech, large public companies that are thinking more broadly about women's health.”