FDA Approves At-Home HPV Test as Alternative to Pap Smear

The new at-home HPV test could expand access to cervical cancer screening for women who avoid or delay Pap smears due to discomfort or lack of access to care.
An illustration of a female doctor examining a lady patient for pap smear.
Patients who test positive for HPV will be referred for a traditional pap smear.Freepik
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The Food and Drug Administration just approved an at home test that could be an optional alternative to a yearly pap smear.[1] The test looks for human papilloma virus, or HPV, which causes nearly all incidences of cervical cancer. 

Each year in the U.S., about 11,500 new cases of cervical cancer are diagnosed and about 4,000 women die of this, according to the Centers for Disease Control and Prevention. Current recommendations from the American Cancer Society (ACS), the American College of Obstetricians and Gynecologists (ACOG), and the US Preventive Services Task Force are for patients to have a pap smear every three to five years. Pap smears test for cancer and precancerous cells but also look for HPV. 

The at home test allows a woman to swab her vagina with a sponge like tool on her own rather than the speculum used for an in office gynecologic pap smear. Patients order the test online, consult with a doctor via telehealth, collect their own sample, and mail it in for analysis.

This test will look for the HPV virus. Patients who test positive for HPV will be referred for a traditional pap smear. Experts say those who do not test positive for HPV, have virtually no risk of cervical cancer at that time and no further screening will be needed for three to five years.

A medical illustration with a virus particle near the cervix indicating hpv causing cervical cancer.
While most HPV infections clear up on their own without causing any health problems, persistent infections with certain high-risk HPV types can lead to cancers including cervical, vagina, vulvar andWikimedia Commons

“Some women are scared of a traditional pap smear or find the process uncomfortable, as a result they put off this vital test,” said Ami Vaidya M.D., Co-Chief of gynecologic oncology at Hackensack University Medical Center’s John Theurer Cancer Center. “This could be an important tool in getting more women regularly screened, especially those that don’t have access to a medical provider. Any type of test that helps detect cervical cancer is a win.”

HPV is a common virus that can cause several types of cancer. While most HPV infections clear up on their own without causing any health problems, persistent infections with certain high-risk HPV types can lead to cancers including cervical, anal, throat, tongue and tonsils, vagina, vulvar and penile. 

Hackensack Meridian Health experts are available to discuss the new at home cervical cancer HPV test and the right times to use it.

Reference

1) https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-first-at-home-test-cervical-cancer-screening-2025-05-09/

(Newswise/TL)

An illustration of a female doctor examining a lady patient for pap smear.
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