The Health Resources and Services Administration (HRSA), an agency within the U.S. Department of Health and Human Services, recently released updated guidelines for cervical cancer screening. These new recommendations expand options for women by permitting those aged 30 to 65 with an average risk of cervical cancer to utilize self-administered Human Papillomavirus (HPV) tests, aiming to increase screening rates and reduce barriers to care.
Federal Guidelines Expand Cervical Cancer Screening Options
The updated HRSA guidance, released on a recent Monday, marks a shift in cervical cancer screening protocols. Healthcare officials, in an editorial published in the Journal of the American Medical Association (JAMA), stated that self-collection methods hold the potential to increase screening rates and save lives.
Updated Recommendations
For average-risk women aged 30 to 65, the updated HRSA guidance prioritizes HPV testing every five years. This test identifies human papillomavirus, which healthcare professionals, such as Dr. Ebony Hoskins, Section Director of Gynecologic Oncology at MedStar Washington Hospital Center, state is responsible for 95% to 99% of cervical cancer cases. The HPV test can be performed either by a clinician or through a patient self-collected sample.
Alternative screening choices for women aged 30 to 65 include a combination of an HPV and Pap test every five years, or a Pap test alone every three years if HPV testing is not available. Pap smears, while still available, are no longer designated as the primary cervical cancer screening method for women aged 30 and above. For women aged 21 to 29, the recommendations remain unchanged: Pap tests every three years.
Self-Collection and Accessibility
The introduction of self-collection options for HPV tests is intended to expand access to screening. This approach aims to address potential barriers that may prevent individuals from attending in-office appointments, such as scheduling difficulties, discomfort during pelvic exams, or transportation issues. Federal health officials anticipate these guidelines will increase screening rates, particularly for women in rural areas or those with limited access to health clinics. Some women may also prefer the privacy and comfort associated with self-swab tests.
Self-administered HPV tests typically involve inserting a plastic tube into the vagina and twisting a handle to collect cells for laboratory analysis. In contrast, Pap smears require a clinician to use a speculum to widen the vaginal canal and swab the cervix for cell collection. Studies have indicated that self-swab HPV tests demonstrate similar accuracy to those administered by a clinician.
FDA Approvals and Devices
The Food and Drug Administration (FDA) has expanded approvals to include self-collection methods. As of 2024, two self-swab tests for clinical use were approved. The FDA specifically approved self-collection in clinical settings in May 2024, and the first at-home self-collection cervical cancer screening kit received approval in May 2025.
The Teal Wand is an example of an FDA-approved device designed for at-home screening. This device operates similarly to a tampon, enabling individuals to collect their own sample for laboratory submission. For devices like the Teal Wand, virtual medical provider support is available, and they require a prescription.
Insurance Coverage and Costs
Private health insurers are generally mandated to cover preventive services recommended by HRSA. Consequently, these insurers are required to integrate the new screening guidelines and cover associated follow-up testing by January 1, 2027. This mandate includes coverage for self-collection kits. The updated guidance also clarifies that insurers must cover follow-up testing and diagnostic evaluations—such as additional Pap tests, biopsies, and laboratory work—without cost-sharing for the patient, in cases of abnormal screening results. A separate HRSA guideline, effective January 1, mandates insurance coverage for patient navigation services, which assist women with scheduling, addressing care challenges, and follow-up.
The Teal Wand, as an at-home test, has an out-of-pocket cost of approximately $250, with some insurance plans providing coverage. Specific access details may vary by insurer.
Public Health Context and Trends
Cervical cancer is a preventable disease. Data from the Centers for Disease Control and Prevention (CDC) indicate that approximately 4,000 women in the U.S. die from cervical cancer annually, with about 13,000 new cases diagnosed each year. Early detection is crucial; five-year survival rates exceed 90% when cancer is found early, compared to approximately 20% for later-stage diagnoses. Cervical cancer screening has contributed to a more than 50% reduction in incidence and deaths in the U.S. over the last 50 years.
Despite progress, approximately one in four women aged 21 to 65 in the U.S. are not current with their cervical cancer screening recommendations. Roughly half of all cervical cancer diagnoses occur in women who have not been screened or whose screening is not up-to-date. Screening rates in this demographic decreased following the COVID-19 pandemic, from 47% in 2019 to 41% in 2023.
Annual incidence rates have increased among women in their 30s and early 40s. Potential contributing factors include delayed screenings or decreased uptake of HPV vaccinations, which were approved in 2006. HPV vaccines can prevent over 90% of cervical cancers, and routine screenings are designed to detect HPV infections or precancerous cells. Approximately 20% of cervical cancer cases occur in women over 65, a demographic often not included in routine screening protocols.
It is important to note that a positive HPV test result indicates the need for further diagnostic testing and does not constitute a cancer diagnosis.
Related Recommendations
In December, the American Cancer Society (ACS) also updated its recommendations, endorsing self-swab HPV tests every three years for women aged 25 to 65, while prioritizing clinician-administered HPV tests every five years.
A Cervical Cancer Summit for patients, survivors, caregivers, and advocates is scheduled to take place in Washington D.C. at the end of January.