- The FDA approved an at-home screening test for cervical cancer.
- The cancer is usually caused by the human papillomavirus.
- Many women skip screening because of access or discomfort with the process.
Women now have an alternative to the Pap smear as a screening test for cervical cancer. The U.S. Food and Drug Administration on Friday approved an at-home screening test.
As Reuters reported, Pap smears have greatly reduced the incidence of cervical cancer in their 80 years of use. But they also require a very personal in-clinic exam and some women skip them because that’s uncomfortable or for other reasons.
According to the new test’s manufacturer, Teal Health, in a study of more than 600 women, self-collected samples were as accurate when analyzed as those collected by a clinician.
On its website, Teal Health reports that the Teal Wand used for in-home sample collection detects cervical precancer 96% of the time, which is the same as the samples collected in a clinical setting.
The process involves ordering a kit and having a short visit with a Teal provider to learn about at-home screening. When the kit arrives, women collect the cell sample themselves using the spongelike wand, then mail the sample to the lab to be analyzed. Results are provided via patient portal that will connect the individual to a provider if follow-up is needed.
Right now, the tests are being made available in California, but that will soon expand. And they are only prescribed by the Teal health care provider, but that will also change as the product rollout continues.
The New York Times notes similar tests were approved by the FDA last year for use in medical offices. “But the at-home version could help women who have trouble finding, traveling to or making time for an in-person appointment.”
Kara Egan, Teal’s chief executive and co-founder, told the Times that the company is now working with insurers so they will cover the test. And it’s working with donors, as well, “to try to subsidize the cost for people without insurance.”
What the test will cost is not yet known. And medical experts warn the test will not remove the need for women to see a gynecologist. An annual exam does more than check for cervical cancer, Dr. Jessica Kiley, chief of general obstetrics and gynecology at Northwestern Medicine in Chicago, told NBC News.
About cervical cancer and screening
The American Cancer Society reports that for 2025, about 13,360 new cases of cervical cancer are expected and roughly 4,320 women will die from the disease.
But cervical cancer detected early is very treatable. While it was once one of the top five cancer killers of women, the death rate has been more than halved in the last 50 years due to prevention and screening. With regular screening, it’s most often found in the pre-cancer stage when it’s very treatable.
The disease starts in the cervix, which connects the uterus to the vagina. Most cases are caused by human papillomavirus (HPV). In a Pap smear or with the in-home screening, cells are collected and tested for presence of the virus.
Although there is a vaccination against the virus, public health agencies still recommend women ages 21-65 be screened every three to five years, depending on their histories, as long as they have not had a full hysterectomy.
“In December, draft recommendations from the U.S. Preventive Services Task Force endorsed self-collected vaginal tests as an option for HPV testing, and said HPV testing should be the primary screening method for cervical cancer for patients 30 and older. The task force continued to recommend Pap smears for patients under 30, but added that self-collected tests offered another option for people who face barriers getting to the doctor or find Pap smears uncomfortable," per the Times.
Older women and screening
The Centers for Disease Control and Prevention notes that women over 65 may also need to be screened. “The only way to know it is safe to stop being tested after age 65 is if you have had several tests in a row that didn’t find cancer within the previous 10 years, including at least one test in the previous five years, per the CDC.
And women with a history of cervical lesions or cancer, those whose mothers took a hormone called diethylstilbestrol (DES) while pregnant and women with a weakened immune system may also need screening after age 65 and should discuss it with their doctor, per the CDC.
If a test is positive, access to care could still be a problem.
“A recent report in JAMA Network Open found that women in rural areas are 25% more likely to be diagnosed with cervical cancer and 42% more likely to die from the disease than women who live in cities, a trend that likely reflects lower access to screenings and care in rural parts of the country," per NBC News.