Clinicians can now allow women to collect their own vaginal sample for cervical cancer screening in their office, according to an updated guideline published in CA: A Cancer Journal for Clinicians. The guideline also offers new criteria for women to discontinue routine screening by age 65, based on risk.
Created by the American Cancer Society (ACS), the recommendations reflect developments in disease detection since 2020 and apply to women and individuals with a cervix at average risk for cervical cancer. Rates of cervical cancer screening remain below pre-pandemic levels, and additional options for screening have the potential to reach more women for early detection and management, said Sarah Temkin, MD, physician-scientist, gynecologic oncologist, and senior director of early detection at the ACS.
“Not every primary care doctor’s office has the setup for collecting specimens for HPV testing, and the removal of this particular barrier to screening access with self-collection is exciting,” Temkin said.
Two primary HPV tests (the cobas HPV from Roche and the Onclarity HPV assay from Becton, Dickinson and Company) received additional approval from the FDA in 2024 for vaginal samples collected by the patient in the clinic setting, in addition to the previously approved clinic-collected cervical samples.
The American Society for Colposcopy and Cervical Pathology (ASCCP) and the American College of Obstetricians and Gynecologists (ACOG) also publish guidance on cervical cancer screening. ACOG’s latest iteration, endorsed by ASCCP, notes the potential of self-sampling to increase access to screening in the future, whether collected in the office or home. ACOG does not currently recommend self-sampling in routine practice because of the lack of long-term data to support utility and effectiveness.
A recent study in JAMA Internal Medicine showed a significant increase in rates of screening for cervical cancer when individuals used self-collection kits in a clinical setting.
At-home self-collection, which would involve a wand-type device, is not yet part of any cervical cancer screening guideline. One version of the device (the Teal Wand) was approved by the FDA in May 2025 but is not yet available for use outside of clinical trials. A current trial in progress at 25 sites across the US has shown positive early results of unsupervised, at-home sample collection and will inform future recommendations for primary HPV-based cervical cancer screening, Temkin said.
Sample Collection and Exit Tickets
Primary HPV testing, defined as stand-alone HPV testing without cytology, was recommended as the preferred initial screening method in the ACS 2020 guideline. New this year, primary testing is recommended every 5 years after a negative result starting at age 25 years and continuing until age 65 years.
Primary HPV testing is used to check for high-risk HPV types most likely to cause cancer, including HPV 16 and 18. If this test is positive, clinicians conduct a cytology test (pap test) on the same sample. The HPV test identifies the virus, while cytology identifies the abnormal cells on a positive primary test that signal the need for treatment.
However, only two primary HPV tests are currently approved by the FDA, and availability is limited, especially in rural and underserved areas.
If primary HPV testing is not available, an older HPV test combined with cytology should be administered every 5 years, or cytology testing every 3 years.
Individuals who submit their own collected vaginal specimens must undergo screening every 3 years.
Individuals who demonstrate negative primary HPV tests or negative combination testing at ages 60 and 65 years do not require further screening, according to the updated guideline. In the absence of primary HPV tests or co-testing, three consecutive negative cytology tests are required with the final test at age 65.
However, clinicians must conduct additional assessments of individuals at higher risk based on immune suppression, to exit further screenings.
Regardless of how a sample is collected, clinicians should remind patients that screening is a process, Temkin said.
“It is not just the test, but also the follow-up and need for additional testing if a result is positive,” she said.
Looking ahead, more research is needed on the long-term effectiveness of the self-collection kits, Temkin said.
Education Is Key to Successful Screening
Self-collection of vaginal samples has the potential to overcome several barriers to care, said Katya Papatla, MD, assistant professor of obstetrics, gynecology, and reproductive science at the Yale School of Medicine in New Haven, Connecticut, who was not involved in writing the guideline.
The ability for a patient to collect their own vaginal sample increases patient autonomy, which is especially important for those who may avoid routine gynecologic care because of previous trauma or discomfort with a pelvic exam, Papatla said. However, potential for human error abounds at every point in the screening process, including whether a self-collection kit was correctly used.
“If patients aren’t able to perform the self-sampling accurately or correctly, there may be an increased risk for false-positive results, she said.
Some low-risk patients may feel they still need more regular testing, Papatla said. If patients are concerned “we should make sure that patients don’t leave a clinical visit without understanding their personal cervical cancer risk,” she said.
Tamkin and Papatla reported having no financial conflicts.
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