Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance

Warner K. Huh, Kevin A. Ault, David Chelmow, Diane D. Davey, Robert A. Goulart, Francisco A. Garcia, Walter K. Kinney, L. Stewart Massad, Edward J. Mayeaux, Debbie Saslow, Mark Schiffman, Nicolas Wentzensen, Herschel W. Lawson, Mark H. Einstein

Research output: Contribution to journalArticle

43 Scopus citations

Abstract

In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated screening guidelines for the early detection of cervical cancer and its precursors. Recommended screening strategies were cytology or cotesting (cytology in combination with high-risk HPV (hrHPV) testing). These guidelines also addressed the use of hrHPV testing alone as a primary screening approach, which was not recommended for use at that time. There is now a growing body of evidence for screening with primary hrHPV testing, including a prospective US-based registration study. Thirteen experts including representatives fromthe Society of Gynecologic Oncology, American Society for Colposcopy and Cervical Pathology, American College of Obstetricians and Gynecologists, American Cancer Society, American Society of Cytopathology, College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for primary hrHPV screening. This guidance panel was specifically triggered by an application to the FDA for a currently marketed HPV test to be labeled for the additional indication of primary cervical cancer screening. Guidance was based on literature review and review of data from the FDA registration study, supplemented by expert opinion. This document aims to provide information for health care providers who are interested in primary hrHPV testing and an overview of the potential advantages and disadvantages of this strategy for screening as well as to highlight areas in need of further investigation.

Original languageEnglish (US)
Pages (from-to)91-96
Number of pages6
JournalJournal of Lower Genital Tract Disease
Volume19
Issue number2
DOIs
StatePublished - Apr 27 2015
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

Keywords

  • Cancer
  • Genotypes
  • HPV
  • Pap
  • Prevention
  • Screening

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  • Cite this

    Huh, W. K., Ault, K. A., Chelmow, D., Davey, D. D., Goulart, R. A., Garcia, F. A., Kinney, W. K., Massad, L. S., Mayeaux, E. J., Saslow, D., Schiffman, M., Wentzensen, N., Lawson, H. W., & Einstein, M. H. (2015). Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance. Journal of Lower Genital Tract Disease, 19(2), 91-96. https://doi.org/10.1097/LGT.0000000000000103