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 corporate 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 might be self-administered at home, slightly than at a health care provider’s office.
“The pandemic showed everyone that telehealth is a thing that’s preferred … and made it easier to get look after most Americans,” said Kara Egan, CEO of Teal Health, adding that Covid also demonstrated “at-home testing was a thing that individuals could handle and really understand.”
The Teal Wand works very similar to a tampon applicator, with a big swab that the user can insert themselves to gather a sample for testing. The FDA designated the tool as a breakthrough device after the corporate’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.
Teal plans to make the wand available in California first, starting in June.
The corporate has had discussions with carriers about insurance coverage for the test as a preventive screening, which for most ladies can be covered without copays identical to 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, partially because they cannot make time for an in-person gynecologist appointment, an issue especially for ladies in rural areas who often should travel beyond their community to get to a health care provider. Â
“That is about increasing access to care and ensuring now 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 assist ramp up production for the launch of the Teal Wand. The investment was led by Forerunner Ventures and Laurene Powell Jobs’ Emerson Collective. The corporate has raised a complete of $23 million from investors including Serena Williams’ Serena Ventures, in addition to testing firm LabCorp. Â
The corporate’s milestone comes as investors have grown more excited by women’s health tech.
Last yr, there was an influx of $680 million into the space invested across 30 deals, in accordance with data from Deloitte. About 60% of those funds went to later-stage investments, in accordance with 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 actually more cautious, on the whole, interest in women’s health tech is moving beyond maternity and menopause. Â Â
“Many more persons are excited about women’s health more broadly and supporting most of these innovations — and that features from the massive, established players like medtech, pharma, biotech, large public corporations which can be considering more broadly about women’s health,” Ghiya said.
