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Although the value of molecular testing for nucleic acids of oncogenic HPV genotypes in primary screening for cervical cancer is now widely accepted, implementation of this screening technology remains slow. Only a few jurisdictions have taken the steps to adopt HPV testing as the anchor technology in cervical cancer screening. The most important challenges are fear of change, logistical complexities, and lack of proper health economic planning for programmatic changes in screening. Only cytology, with its 70-year history, is unequivocally linked to enduring reductions in cervical cancer incidence and mortality in resource-rich countries. However flawed as a technology, judged by the performance of today’s molecular-based counterparts, cytology screening is judged as an effective strategy that relies on a well-established workforce of trained cytotechnicians and cytopathologists.
Although the potential for improvement is substantial, there are many questions to be solved by implementation research, which will give policymakers confidence in making the changes from cytology to molecular testing and eventual incorporation of genotyping and biomarker-based staining of cytology smears. Is HPV plus Pap cytology cotesting, a policy widely adopted in the U.S., the only approach with sufficient safety for cervical cancer screening? Is HPV testing followed by cytologic triage a more cost-effective approach than cotesting? Is the inclusion of real-time partial genotyping during screening a cost-effective option, with or without cytology triage? Should HPV-based policies be reserved for women ages 25 (or 30) and older only? If so, what screening options should be recommended for younger women? Does the latter question matter, given that HPV vaccination is largely eliminating the high prevalence of HPV positivity among young women? Is self-sampling a solution to expand the coverage and bring equity to screening? US guidelines will gradually migrate to risk management based on a multiplicity of assay results providing more nuanced risk stratification. Would this serve as a universal solution across all high income countries? As HPV testing and ancillary molecular tools make inroads in cervical cancer screening, policymakers, physicians and healthcare payors cannot confidently decide among a bewildering array of strategies. Benchmarks of performance are urgently needed and realistic standards for regulatory approval must also be adopted to permit innovation and rapid deployment of validated molecular technologies.
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