FDA Approves At-Home Alternative to the Pap Smear

January 05, 2026

A young woman is checking the delivery label on a package

The U.S. Food and Drug Administration has approved the first at-home test for cervical cancer screening. The test makes it easier for women to get regular screenings for early detection of cervical cancer and precancerous cells, without visiting a doctor.

“The self-collection test will help improve screening rates and I’m hopeful cervical cancer rates will decline,” says University Hospitals gynecological oncologist Stacy Smrz, MD, MPH. “Self-collection is a great option for certain patients. They’re not designed for patients at higher risk. But for patients considered lower risk, this is a good test that can be done in place of a traditional PAP test.”

How the Testing Works

For many women at average risk for cervical cancer, the screening tests are an alternative to Pap smear tests. The at-home test looks for signs of high-risk types of human papillomavirus (HPV), which is the cause of nearly all cervical cancers.

“Cervical cancer screening has come a long way,” Dr. Smrz says. “In the past, it was primarily sampling cells of cervix. But as our knowledge about the cause of most cervical cancers has evolved, screening has evolved as well.”

Unlike a Pap smear, where a doctor collects cells from the cervix, the HPV test kits provide a long cotton swab for swabbing the vagina, either at a health clinic or at home. The at-home test must be ordered by a healthcare provider.

Pap Tests Are Still Important

Pap tests are still recommended for some women. Self-collection tests aren’t recommended for anyone with a history of cervical cancer, precancers or abnormal results; or women with suppressed immune systems or who have had organ or stem cell transplants.

Women should talk to their healthcare provider about whether self-collection is the right test for them. Routine cervical cancer screenings are recommended starting at age 21 until age 65:

With self-collection, testing is recommended every 3 years if the test is negative for HPV.
When cervical samples are collected by a healthcare provider, repeat testing is recommended every 5 years if results are negative.

Cervical Cancer Rates

Cervical cancer rates dropped by more than half from the mid-1970s to the mid-2000s, largely because of the increase in screening, according to the American Cancer Society.

Rates have stabilized over the past decade, but they’re rising in women ages 30 to 44. The HPV vaccine is believed to have lowered the rate of cervical cancer in women ages 20 to 24. About 13,000 invasive cervical cancer cases are diagnosed yearly in the United States.

Breaking Barriers

Some women face barriers to clinic-based cervical cancer screening. “One barrier is some people just can’t access healthcare,” Dr. Smrz says. “There are geographic and economic barriers. Low-income and rural communities can have access issues. Other barriers are transportation, education and other socioeconomic issues.”

Some women also are uncomfortable undergoing a pelvic exam, so self-collection can be a less stressful alternative.

“Hopefully, this will break down some of the barriers to screening that women encounter,” she says. “This is a cancer that, in large part, can be prevented. We just have to find a way to reach more women and work together to overcome screening barriers.”