“Otherwise,” she says, “it’s going to happen without us.”
Dr. Nayar chaired the Primary HPV Screening Initiative’s laboratory infrastructure workgroup and currently co-chairs the ACS National Cervical Cancer Roundtable’s primary HPV screening workgroup.
At professional meetings across the country, she and Christine Booth, MD, a member of the initiative and chair of the laboratory infrastructure workgroup’s quality assurance subgroup, have discussed primary HPV screening, addressing laboratory-related questions and quality. “We talk about the why, the when, and the how. And the when is now,” Dr. Nayar says.
Why now? For starters, HPV vaccination. “Performance of cytology isn’t the same as it used to be because with HPV vaccination, disease prevalence has gone down,” she says, and education efforts aimed at stakeholders are key to increasing the understanding of the impact of vaccination on secondary prevention. The nine-valent version of the HPV vaccine, approved by the FDA in 2014, protects against 90 percent of cervical cancers and 75 to 85 percent of the high-grade lesions (CIN2/3). Moreover, one dose has been found to have protection that is similar to that of the previously recommended two- or three-dose series, and the American Academy of Pediatrics is now recommending the vaccine for children starting at age nine. “Vaccinees are entering the screening pool now,” Dr. Nayar says. “It’s not a sudden transition, but it’s happening, and it will continue.” With greater HPV vaccine uptake—and 76.9 percent of U.S. adolescents had at least one dose before the COVID pandemic—precancer will become more of a rarity and experience with detecting it on cytology will decline. HPV testing, on the other hand, does not rely on human locator skill and interpretation.
Another reason: the wider availability of FDA-approved primary HPV testing platforms. With FDA approval in 2023 of the Abbott Alinity m HR HPV assay, “we have three total now,” she says. (The others are the Roche Cobas HPV test and the BD Onclarity HPV assay.) Triage options for HPV positives have also improved and include the p16/Ki-67 dual stain (see CAP TODAY, https://bit.ly/41BQc5C) and HPV genotyping. The BD Onclarity and Alinity assays provide extended genotyping, which identifies individual types or groups of types beyond HPV 16, 18, and 45 and further stratifies the individual’s risk for precancer/cancer.
Then, too, there are the advances in clinical practice, exemplified by the ASCCP’s 2019 risk-based management consensus guidelines, in which HPV-based testing forms the basis of risk assessment. “What these guidelines do is allow for precision prevention,” Dr. Nayar says. “We talk about precision medicine, but usually that applies to treatment. Now we’re saying, ‘Why shouldn’t prevention be precise and tailored to the individual and allow for more timely intervention in those at higher risk and less intervention for low-risk individuals?’” In practice, this means the guidelines consider not only current test results but also the patient history. Patients A and B could each have an equivocal lesion (ASC-US L) and a positive HPV test result, for example, but be managed differently because of disparate prior test results. “Past history makes all the difference in the immediate and five-year risk of precancer/cancer,” she says.