The FDA’s approval of self-collection in May 2024 also tips the balance in favor of primary HPV screening, since these specimens are suitable only for HPV testing. “These are vaginal samples, so you can’t make a cytology preparation or, for that matter, do a dual stain triage for HPV positives,” she says. The U.S. Preventive Services Task Force draft recommendations for cervical cancer screening, released for public comment on Dec. 10, 2024, endorse clinician- or patient-collected high-risk HPV primary screening in women ages 30 to 65 every five years.
For all the arguments that hinge on technology and practice, it’s the issue of staffing that may be most convincing for some. In short, good cytology requires highly trained professionals, and the workforce shortage, coupled with the decline in disease prevalence, delivers something of a one-two punch. “Finding precancer on cytology is going to become so rare that screeners are not going to be familiar with it,” Dr. Nayar says, resulting in false-negatives or equivocal/atypical diagnoses that put more patients into the surveillance pool. “With that comes emotional distress, cost, time, and resources,” she says, “causing more harm than benefit.” New artificial-intelligence-assisted liquid cervical cytology has the potential to increase sensitivity and reproducibility of cytology-based screening methods.
Dr. Nayar doesn’t discount the work that she and other members of the ACS National Cervical Cancer Roundtable’s Primary HPV Screening Initiative have done to ease the transition. The initiative’s work, she says, is yet another reason why the U.S. is now better prepared for primary HPV screening. “Our goal is to provide resources for making this transition at all levels—provider, lab, payers, patients. We’ve done that and we’re continuing to do that,” she says. “We now have resources that were not available before.”
Dr. Booth is aware that the move to primary HPV screening will involve new steps and new workflows for many laboratories.
“Laboratories need to know their current test location and setup for HPV testing,” she says. “Are they performing it in the microbiology laboratory, the molecular laboratory, the cytopathology laboratory, or is it being performed as a send-out test?” Depending on where testing is occurring, “it’s likely the triage test would be happening in another laboratory,” she says, noting the importance of communication between the two. “All these things could affect the workflow as well as the quality of the testing.”
In her role as laboratory quality assurance subgroup chair within the initiative, Dr. Booth studied these quality assurance implications. (She’s also director of regional cytology at Cleveland Clinic and professor of pathology, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University School of Medicine.) Specimen aliquoting and transfer are part of the cotesting workflow as well, she notes. “But with the new workflows, we need to be careful that specimens aren’t being lost in transition from one place to another and that the appropriate samples are being sent and have enough material left in them.”