Teal Health At-Home Cervical Cancer Screening Test Wins FDA Approval

The Food and Drug Administration on Friday approved the first-ever at-home test for cervical cancer screening, developed by San Francisco-based startup Teal Health. The company began developing the prototype for its Teal Wand just over five years ago. The concept was to make cervical cancer screening more accessible via telehealth and a test that could be self-administered at home, rather than at a doctor’s office.

Development and Approval

“The pandemic showed everyone that telehealth is a thing that is preferred … and made it easier to get care for most Americans,” said Kara Egan, CEO of Teal Health, adding that Covid also demonstrated “at-home testing was a thing that people could handle and really understand.” The Teal Wand works much like a tampon applicator, with a large swab that the user can insert themselves to collect a sample for testing. The FDA designated the tool as a breakthrough device after the company’s clinical trial results showed the precision of the self-administered test was comparable with an in-office screening performed by a clinician, with a 96% accuracy rate.

Availability and Insurance Coverage

Teal plans to make the wand available in California first, starting in June. The company has had discussions with carriers about insurance coverage for the test as a preventive screening, which for most women would be covered without copays just like an annual doctor’s visit. The American Cancer Society recommends women get screened for cervical cancer every three years starting at age 21. Yet Egan says 1 in 4 women fall behind on screening, in part because they can’t find time for an in-person gynecologist appointment, a problem especially for women in rural areas who often have to travel beyond their community to get to a doctor.

Increasing Access to Care

“This is about increasing access to care and making sure we have more options to get that care,” she said. Ahead of its anticipated FDA approval, Teal Health raised $10 million in its latest funding round in January to help ramp up production for the launch of the Teal Wand. The investment was led by Forerunner Ventures and Laurene Powell Jobs’ Emerson Collective. The company has raised a total of $23 million from investors including Serena Williams’ Serena Ventures, as well as testing firm LabCorp.

Growth in Women’s Health Tech

The company’s milestone comes as investors have grown more interested in women’s health tech. Last year, there was an influx of $680 million into the space invested across 30 deals, according to data from Deloitte. About 60% of those funds went to later-stage investments, according to Jen Radin, principal in Deloitte’s life sciences and health-care practice. “From 2023 to 2024 femtech saw 41% growth, outpacing overall health tech, which grew only 10%,” Radin said. FemHealth Ventures managing partner Maneesha Ghiya says while investors are now more cautious, in general, interest in women’s health tech is moving beyond maternity and menopause.

Conclusion

The approval of the Teal Wand is a significant step forward in making cervical cancer screening more accessible and convenient for women. With its high accuracy rate and potential for widespread availability, this at-home test has the potential to increase screening rates and improve health outcomes for women. As the women’s health tech industry continues to grow, we can expect to see more innovative solutions like the Teal Wand that prioritize accessibility, convenience, and preventive care.

FAQs

Q: What is the Teal Wand and how does it work?
A: The Teal Wand is an at-home test for cervical cancer screening that works like a tampon applicator, with a large swab that the user can insert themselves to collect a sample for testing.
Q: How accurate is the Teal Wand?
A: The Teal Wand has a 96% accuracy rate, comparable to an in-office screening performed by a clinician.
Q: Will the Teal Wand be covered by insurance?
A: Yes, the company has had discussions with carriers about insurance coverage for the test as a preventive screening, which for most women would be covered without copays.
Q: How much did Teal Health raise in its latest funding round?
A: Teal Health raised $10 million in its latest funding round in January to help ramp up production for the launch of the Teal Wand.
Q: What is the current state of women’s health tech investing?
A: Women’s health tech has seen significant growth, with $680 million invested in the space last year, and interest is moving beyond maternity and menopause to include broader women’s health issues.