The Food and Drug Administration (FDA) has granted approval for the first at-home test for cervical cancer screening, developed by the San Francisco-based company Teal Health.
Teal Health embarked on the creation of its Teal Wand prototype just over five years ago, aiming to enhance accessibility to cervical cancer screenings through telehealth and self-administered testing at home, rather than requiring visits to a medical professional.
“The pandemic made it clear that telehealth is preferred by many and streamlined care for a large segment of the American population,” stated Kara Egan, CEO of Teal Health. She emphasized that Covid-19 also showcased the feasibility and appeal of at-home testing options.
The Teal Wand operates similarly to a tampon applicator, enabling users to collect samples for testing using a large swab they insert themselves. The FDA has classified the device as a breakthrough tool, as clinical trials indicated that the accuracy of the self-administered test matches that of in-office cervical screenings, boasting a 96% precision rate.
Teal Health plans to introduce the wand to the California market initially, with availability set to begin in June.
Discussions are ongoing with insurance providers regarding coverage for the test as a preventive screening, which, for most women, would likely incur no copays, much like an annual doctor’s visit.
The American Cancer Society advises that women start cervical cancer screenings every three years at the age of 21.
However, Egan notes that one in four women fall behind on their screenings, primarily due to challenges in scheduling in-person gynecological appointments, a particular hurdle for women in rural areas who may have to travel significant distances for care.
“Our goal is to increase access to care and provide more options for women to receive it,” she said.
In anticipation of the FDA’s approval, Teal Health raised $10 million in a funding round this January, aimed at boosting production in preparation for launching the Teal Wand. This investment was spearheaded by Forerunner Ventures and Laurene Powell Jobs’ Emerson Collective, bringing the total funding to $23 million from investors including Serena Williams’ Serena Ventures and testing company LabCorp.
This achievement coincides with growing investor interest in women’s health technology. According to Deloitte data, last year witnessed $680 million invested across 30 deals in this sector, with approximately 60% of those funds allocated to later-stage investments.
“Between 2023 and 2024, the femtech sector experienced 41% growth, significantly outpacing the 10% increase seen in overall health technology,” reported Jen Radin, a principal in Deloitte’s life sciences and healthcare practice.
Maneesha Ghiya, managing partner at FemHealth Ventures, noted that while investors are currently more cautious, the focus on women’s health technology is expanding beyond maternity and menopause. “There is a growing awareness and support for innovations in women’s health from major established entities including medtech, pharma, and biotech,” she added.
