title: Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance.
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 and cotesting (cytology in combination with 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 from the 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 healthcare 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.
authors.affiliation: University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: whuh@uabmc.edu.
authors.forename: Warner K
authors.initials: WK
authors.lastname: Huh
authors.affiliation: University of Kansas Medical Center, Kansas City, KS, USA.
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Ault
authors.affiliation: Virginia Commonwealth University Medical Center, Richmond, VA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Chelmow
authors.affiliation: University of Central Florida, Orlando, FL, USA.
authors.forename: Diane D
authors.initials: DD
authors.lastname: Davey
authors.affiliation: New England Pathology Associates, Springfield, MA, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Goulart
authors.affiliation: Pima County Health Department, Tucson, AZ, USA.
authors.forename: Francisco A R
authors.initials: FA
authors.lastname: Garcia
authors.affiliation: Kaiser Permanente, Sacramento, CA, USA.
authors.forename: Walter K
authors.initials: WK
authors.lastname: Kinney
authors.affiliation: Washington University School of Medicine, St. Louis, MO, USA.
authors.forename: L Stewart
authors.initials: LS
authors.lastname: Massad
authors.affiliation: University of South Carolina School of Medicine, Columbia, SC, USA.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Mayeaux
authors.affiliation: American Cancer Society, Atlanta, GA, USA.
authors.forename: Debbie
authors.initials: D
authors.lastname: Saslow
authors.affiliation: National Cancer Institute, Bethesda, MD, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Schiffman
authors.affiliation: National Cancer Institute, Bethesda, MD, USA.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Wentzensen
authors.affiliation: American Society of Colposcopy and Cervical Pathology, Frederick, MD, USA.
authors.forename: Herschel W
authors.initials: HW
authors.lastname: Lawson
authors.affiliation: Albert Einstein College of Medicine, Bronx, NY, USA.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Einstein
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D055088:Early Detection of Cancer; D005260:Female; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology