The tool will allow women to screen for HPV, which causes almost all cases of cervical cancer, without visiting a doctor.
Excerpt – The Food and Drug Administration approved the United States’ first at-home cervical cancer screening tool on Friday, a decision that stands to give women an accessible alternative to Pap smears, which many find painful or traumatic.
The new test, made by Teal Health, involves swabbing the vagina with a spongelike tool rather than inserting a speculum and scraping cells from the cervix, as health care providers do in Pap smears. [..]
Cervical cancer experts told The New York Times that the evidence for at-home testing was strong, and studies show it to be about as accurate as Pap smears.
Teal Health will allow patients to order the test online, speak with a telehealth provider, collect a sample and then mail it to be tested for HPV. Kara Egan, Teal’s chief executive and co-founder, said the company was working with insurers to secure coverage and with donors to try to subsidize the cost for people without insurance.
If the test is positive, the patient will be referred to an in-person provider for a Pap smear or colposcopy to check for cancer or precancerous cell changes. (A colposcopy examines the cervix through a magnifying device and allows providers to take biopsies.) If the test is negative, no further screening will be needed for three to five years.
Teal plans to mail an initial round of tests to customers in California next month before expanding to other states. [..]
Dr. Kathy MacLaughlin, an associate professor of family medicine at the Mayo Clinic who studies cervical cancer screening, said more work was needed to ensure patients with a positive home test could find and afford an in-person provider for a follow-up, given that lack of access is a reason they are likely to use the home test to begin with.
“Step 1 is getting more people screened,” she said, but solving the problem of in-person access is “the important Step 2 and 3 and 4.”
Full article, M Astor, 2025.5.9