First at-home test to screen for cervical cancer approved by FDA

Miami Herald

13-05-2025

The U.S. Food and Drug Administration on Friday approved Teal Health to provide the nation's first at-home test kit to screen for cervical cancer.
The Teal Wand, which will be available for those age 25 to 65 at average risk, tests for human papillomavirus, or HPV, a virus that causes most cervical cancers.
Teal Health CEO Kara Egan didn't say how much the test would cost. Egan anticipates the test will be covered by insurance.
They will first be available in California in June and then expand nationwide.
Until now, the only way to screen for cervical cancer was in a doctor's office during a pelvic exam.
'As a mom and a woman, I get how easy it is to put your own health last,' Egan said in a news release. 'That's why this FDA approval means so much; it's not just about an innovative new product, it's about finally giving women an option that actually makes sense for their lives -- something that can be done quickly and comfortably at home. Because when we make care easier to get, we help women stay healthy, for themselves and for the people who rely on them every day.'
Because of the invasive aspect, the company found 1 in 4 women in the United States are behind in testing.
Dr. Emeline Aviki, a gynecologic-oncologist at New York University Langone Health, who worked on initial studies, told CNBC: 'It's not a fun exam and it's the easiest thing to cancel.'
She worked on early studies to validate the new test.
In a Teal Health study, 86% of participants thought they would more likely stay up-to-date with cervical cancer screening if they could do it at home. And 94% said they would prefer to self-collect at home if it were accurate.
In the new vaginal swab, a speculum is used and samples of cells are collected from the cervix.
Last year, the FDA approved a similar swab, also performed by patients themselves, that's collected in a doctor's office.
'What's different about this new indication is that this sample can be collected at home and not in a medical setting,' Dr. George Sawaya, a gynecologist at University of California San Francisco Health, told CNBC. You have to logically believe that would increase access if people's main barrier was getting to a medical setting.'
Patients can order the test kit after a telehealth appointment with a doctor. The swab is then mailed to a lab for analysis.
The product initially must be prescribed by one of Teal Health's virtual providers.
If there is a positive test, women may need additional tests in a doctor's office.
The American Cancer Society estimates that 13,360 women will be diagnosed with cervical cancer this year and about 4,320 women will die. 'Cervical cancer incidence rates decreased by more than half from the mid-1970s to the mid-2000s because of widespread screening uptake,' ACA said.
Cervical cancer mortality rates also dropped by more than half since the mid-1970s.
The study found the test detects cervical precancer 96% of the time.
'As a Principal Investigator in the SELF-CERV trial, I saw firsthand how receptive and excited women were to use the Teal Wand,' Dr. Christine Conageski, associate professor, OB-GYN and director of the Complex Dysplasia Clinic at the University of Colorado, said in the company's news release. 'Cervical cancer is largely preventable, yet screening rates in the U.S. continue to lag, and the FDA approval of this at-home Teal Wand self-collection device is a critical step forward. It offers an evidence-based way to expand access without compromising accuracy.'
She noted women must do more than be tested.
'But access is only part of the solution,' she said. 'Comprehensive screening must go hand in hand with structured, reliable follow-up.'
Last year, researchers found a new urine test might help doctors more easily screen for cervical cancer. The test looks for proteins generated by a type of cancer-causing human papillomavirus, HPV 16.
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