Key Points:
- Home HPV Testing now lets women screen for cervical cancer at home.
- Insurance must cover these tests by 2027 with no out-of-pocket costs.
- Self-collection improves access, privacy, and convenience, especially in rural areas.
Federal health officials for the first time recommend home HPV testing for cervical cancer screening, aiming to boost participation, reduce barriers to care and cut deaths from a largely preventable disease.
The U.S. Department of Health and Human Services said new guidance from the Health Resources and Services Administration adds self-collection of vaginal samples as an option for women at average risk of cervical cancer. The recommendations were published Monday in JAMA.
Guidance Expands Screening Choices for Women
Under the updated guidance, women may collect samples either at a clinician’s office or at home and mail them to a laboratory for testing high-risk strains of human papillomavirus, or HPV. Nearly all cervical cancers are caused by HPV.
Many women avoid screening because pelvic exams can be uncomfortable or traumatic, health officials said. Self-collection is intended to address those concerns while maintaining accuracy.
“Doctors are hopeful this new screening option will increase screening rates and save lives,” said Dr. Ann Sheehy, senior author of the JAMA article and chief medical officer at HRSA.
Research reviewed by the agency shows self-collected samples are as effective as samples collected by health care providers. Unlike rapid COVID-19 tests, Home HPV Testing requires mailing specimens to a lab, and results are not immediate.
Cervical cancer was diagnosed in more than 13,000 U.S. women last year and caused more than 4,300 deaths, according to federal data.
Insurance Coverage Mandated by 2027
Insurance plans must cover the full cost of Home HPV Testing by Jan. 1, 2027, with no out-of-pocket costs to patients, including follow-up testing, HRSA said. The requirement stems from the Affordable Care Act, which mandates coverage for preventive services recommended by certain federal bodies.
HRSA is one of three such groups. The others are the U.S. Preventive Services Task Force and the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention.
In an average-risk population, about 10% to 15% of women screen positive for HPV, said Robert Smith, senior vice president of early cancer detection science at the American Cancer Society. Positive results may require additional procedures to check for cancer.
The American Cancer Society updated its own cervical cancer screening guidance in December to include self-collection. Smith said recent approvals by the Food and Drug Administration made the change possible.
The FDA approved the first HPV test allowing women to collect samples in a clinician’s office in 2024 and authorized the first home test in 2025.
Officials Say Self-Collection Can Close Gaps
Home-based testing has expanded rapidly in recent years. While flu and COVID-19 tests are most familiar, the FDA also has approved over-the-counter tests for sexually transmitted infections such as chlamydia, gonorrhea and trichomoniasis. Prescription home tests for colorectal cancer have been available since 2014.
Health officials say Home HPV Testing could help reverse declining cervical cancer screening rates. The share of U.S. women who received recommended screening dropped from 47% in 2019 to 41% in 2023, according to a study published last year.
Screening rates are especially low in rural areas, where women may travel long distances for gynecologic care. Rural women are 25% more likely to be diagnosed with cervical cancer and 42% more likely to die from it than women in urban areas.
“Numerous studies have demonstrated the potential for self-collection to increase screening rates, including in historically hard-to-reach populations,” Sheehy and her coauthors wrote.
Officials also cited added privacy and convenience, particularly for women without reliable transportation or flexible work schedules. The guidance notes that self-collection may make screening less uncomfortable and more accessible for women facing logistical barriers.
Federal health leaders emphasized that Home HPV Testing is intended to complement, not replace, traditional care and encourage more women to participate in routine screening.
