Cervical cancer self-test in U.S. gets federal endorsement

Millions of women in the United States have missed going to their doctors for a Pap smear — a key tool in early detection of cervical cancer — whether it be to avoid pain, a cultural sensitivity or other barriers.

Many women will soon have access to a potentially life-saving alternative: a test they can do at home for the disease, according to new federal guidelines announced this week.

Health insurers must next year cover the self-tests, which the U.S. Food and Drug Administration has previously approved for at-home and clinical use. Research has shown that self-collected tests have similar efficacy as when a medical doctor does the screening, according to the Health Resources and Services Administration (HRSA), which made the announcement and is part of the U.S. Department of Health and Human Services.

"These updates represent a significant step forward in cervical cancer screening and will improve screening rates and save lives," HRSA Administrator Tom Engels said in a statement Monday. "By expanding screening options and removing cost barriers, we’re helping more women take an active role in protecting their health and their future."

Over the last half-century, cervical cancer frequency and death rates have declined more than 50% nationally, government researchers said.  Still, in 2025, about 4,000 women died of cervical cancer, according to the National Cancer Institute. About 13,000 women were diagnosed with the disease.

Currently, cervical cancer tests are primarily conducted during a pelvic examination, according to the National Cancer Institute. Cervical cells are taken and analyzed during a Pap smear. Women also can receive a test for high-risk human papillomavirus (HPV), which leads to nearly all cervical cancer cases and can be spread through sex. There is also a co-test for HPV and the Pap smear.

A Pap smear is generally suggested every three years for average-risk women ages 21 to 29, researchers said. After that, they should be tested for HPV or receive a co-test every five years until 65. Testing is not recommended for those over 65. If a person has an abnormal test result, a physician could suggest several options, including further monitoring or additional testing, according the institute.   

Still, roughly a quarter of women in the United States who are due for the test don't get it, according to government researchers.

The self-collection option, physicians said, will enable women who avoid getting the Pap smear to get tested. A 2025 study conducted by a company that received FDA approval for at-home testing found "HPV when precancer was present 96% of the time," equal to when a physician took a collection.  

Public comments listed in the Federal Register were mostly positive about the self-collection options, though some remarks said more frequent self-collection should be recommended. The government response said, "No changes were made to the recommendation as self-collected samples had a similar test accuracy as clinician-collected" samples.

Medical doctors say the additional testing option, in conjunction with HPV vaccination, can help in nearly eradicating cervical cancer in the United States. The vaccine can prevent more than 90% of HPV that leads to cancer, the Centers for Disease Control and Prevention said.

The self-collected option is geared toward average-risk women ages 30 to 65, according to HRSA.

Any barrier to screening for this disease that can be brought down will save lives, said Dr. Kevin Holcomb, chair of obstetrics and gynecology at North Shore University Hospital and Long Island Jewish Medical Center. "Every cervical cancer death is a tragedy because it's one of the most preventable cancers."

Still, Holcomb expressed concern that some women might skip annual checkups with their OB-GYN, primary care providers who can help patients through other health issues, including nutrition, vaccination and smoking cessation.

"We see ourselves as specialists in women's care," he said in an interview. "And that goes beyond just reproductive health."

Dr. Nicholas Teodoro, an OB-GYN and an associate director for Global Women's Health at Stony Brook Medicine, said the United States could nearly eliminate cervical cancer in the future through robust vaccination and better screening of women who may be hesitant about going to a physician’s office.

"Overall, I just think it's a nice tool kit to have," he said of the self-screening. "And I'm really hoping it's able to reach women who don't have as much access, or women who, you know, have been marginalized or stigmatized, don't feel comfortable going to the doctors."

By Tiffany Cusaac-Smith

tiffany.cusaac-smith@newsday.com@T_Cusaac

Tiffany Cusaac-Smith is a general assignment reporter for Newsday. She previously worked at USA TODAY and is an alum of Howard University.