Transition time for primary HPV screening

Charna Albert

January 2025—In the 2024 edition of the CAP accreditation checklists, released on Dec. 26, laboratories can expect to see small but significant changes to the all common, cytopathology, and microbiology checklists. These revisions and additions are meant to ensure test quality as more laboratories begin to offer primary HPV screening and p16/Ki-67 dual stain triage.

There’s another objective behind releasing these changes now, says Carol Rauch, MD, PhD, a member of the CAP Checklists Committee and adjunct associate professor of pathology, microbiology, and immunology at Vanderbilt University School of Medicine. With primary HPV rec-ommended in U.S. cervical cancer screening guidelines, the revised accreditation requirements are intended to support laboratories that have transitioned or will transition to this testing and encourage others.

“For CAP-accredited labs, it’s a kind of pointy stick to have the requirements spelled out,” Dr. Rauch says. “And that is an effective way of changing laboratory practice in a timely manner.”

In 2020, when the American Cancer Society (ACS) designated primary HPV as the preferred screening option in average-risk people with a cervix ages 25 to 65, stakeholders openly expressed misgivings. Among them was Ritu Nayar, MD, professor and executive vice chair of pathology at Northwestern University Feinberg School of Medicine. Dr. Nayar helped write the Cytopathology Education and Technology Consortium’s (CETC) official response, on the case for retaining cotesting and cytology as screening options. “I worked with the CETC to write to ACS in 2020 and to the United States Preventive Services Task Force in 2017 to explain why the United States wasn’t ready to transition to primary HPV screening. But things have changed since then,” she says. Dr. Nayar in 2021 joined the ACS Primary HPV Screening Initiative’s steering committee, an expert-led group (nested under the ACS National Cervical Cancer Roundtable) whose goal was to address concerns, develop resources, and identify opportunities to support the transition to high-quality, FDA-approved primary HPV cervical cancer screening in the U.S.

Those efforts notwithstanding, the U.S. will never see a nationwide switch á la Australia, Dr. Nayar says, where all health care facilities use the same laboratory testing platform and electronic health record and where screening is organized rather than opportunistic. “We don’t have an on-and-off switch,” she says of the U.S. “We’re always going to be in transition. And where primary HPV is not available, and cytology is—good cytology is the key—then that should be done.” The 2020 ACS guidelines make clear that regular screening is the most important factor, regardless of the test. “And no test is perfect,” she says. Important to note too is that the recommendation for primary HPV screening applies only to average-risk, asymptomatic patients.

All that said, offering the testing isn’t going to be optional for much longer, and it’s with that in mind that she encourages laboratories to get on board. “The testing is being asked for, it is in the screening guidelines, and to comply with offering it to our patients and providers, pathologists and laboratory professionals need to be at the table to make sure it happens appropriately.”