Startup Teal Health wins FDA approval for at-home test for cervical cancer screening
In clinical trials, the accuracy of self-testing with Teal's wand matched that of a cancer screening performed in a doctor's office.
Lynk
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.
"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 to an in-office screening performed by a clinician, with a 96% accuracy rate.
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 one in four women falls 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.
"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.
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.
"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," Ghiya said.
