ORLANDO, Fla. — Using urine to screen for high-risk types of human papillomavirus (HPV) shows promise in potentially reaching women who decline or lack access to a Pap smear, researchers reported at the 2025 annual meeting of the College of American Pathologists.

Although rates of cervical cancer have declined with advances in vaccination and screening, 25% of eligible women are not current on screening.

“Many populations have difficulty with getting Pap smears — patients with substance abuse disorder, elderly patients who may find it uncomfortable, survivors of sexual trauma, PTSD [posttraumatic stress disorder],” Jessica L. Bentz, MD, with Carolinas Pathology Group in Greenville, South Carolina, said. “We’re trying to minimize that number, so everyone has an opportunity to get screened.”

Urine as Initial Screen

Bentz and her colleagues found a machine (COBAS 6800), commonly used to detect high-risk HPV in Pap smear samples, can detect high-risk HPV (HR-HPV) in urine with high specificity (97%) and positive predictive value (91%) compared with Pap. Sensitivity, however, was 48%, meaning when the current cervical HPV test from a Pap smear sample was positive, the urine HPV test was positive only 48% of the time.

Bentz told Medscape Medical News future work will include improving the collection, storage, and processing of samples to improve sensitivity. While sensitivity was low, it was much higher when the woman had a concurrently or previously positive Pap smear, she added.

Bentz said the team also is working toward finding the least amount of urine that can be used to be sensitive enough to identify HPV. HPV can also lead to cancers in men, so future research may look at whether urine testing could work in that population, she added.

Urine samples may be a first step for screening patients who otherwise would not get screened. “If the test is positive, the patient would go on to a Pap smear or HPV test. If patient’s urine HPV test is negative and she has no risk factors, you could consider re-testing her urine in 1 year, sparing her a pelvic exam,” she said.

The trial included samples from 50 women who came to Dartmouth Medical Center in Hanover, New Hampshire, for a Pap smear and were asked to give a urine sample at the same time. The two samples were run in tandem to determine the presence or absence of HR-HPV genotypes.

Bentz said that to her knowledge, “no one has used the COBAS 6800 and tried to run it in this way. We put it in the same tubes that would be used to process a Pap, so we were comparing apples to apples. We were trying to find a way to use a process that could be incorporated into normal processes that have already been validated in a lot of labs.” 

Potential as Initial Screening

“This study has a potential for being very exciting,” Elena Ratner, MD, a gynecologic oncologist at Yale Cancer Center in New Haven, Connecticut, told Medscape Medical News.

A positive HPV test is highly predictive of an increased risk for cervical, vaginal, and vulvar cancers. “Inability of obtaining HPV and tolerating pelvic exams greatly limits women’s ability to prevent or detect these cancers earlier, greatly affecting patients’ prognosis and overall survival,” she said, adding that the virus also is linked to anal and throat cancer.

“The specificity and positive predictive value are very high and as high as a traditional pelvic exam approach,” Ratner said. “However, sensitivity is lower than the traditional approach. This means that the test may miss a significant number of cases, resulting in false negatives. This aspect of the test must be improved for the screening test to be effective. It can currently be utilized for positive predictive value and negative tests should be rescreened with a traditional Pap smear.”

Bentz and Ratner reported no relevant financial conflicts of interest.

Marcia Frellick is a Chicago-based healthcare journalist and a regular contributor to Medscape.