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 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 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 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.
authors.affiliation: 1University of Alabama at Birmingham, Birmingham, AL, USA; 2University of Kansas Medical Center, Kansas City, KS, USA; 3Virginia Commonwealth University Medical Center, Richmond, VA, USA; 4University of Central Florida, Orlando, FL, USA; 5New England Pathology Associates, Springfield, MA, USA; 6Pima County Health Department, Tucson, AZ, USA; 7Kaiser Permanente, Sacramento, CA, USA; 8Washington University School of Medicine, St. Louis, MO, USA; 9University of South Carolina School of Medicine, Columbia, SC, USA; 10American Cancer Society, Atlanta, GA, USA; 11National Cancer Institute, Bethesda, MD, USA; 12American Society of Colposcopy and Cervical Pathology, Frederick, MD, USA; and 13Albert Einstein College of Medicine, Bronx, NY, USA.
authors.forename: Warner K
authors.initials: WK
authors.lastname: Huh
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Ault
authors.forename: David
authors.initials: D
authors.lastname: Chelmow
authors.forename: Diane D
authors.initials: DD
authors.lastname: Davey
authors.forename: Robert A
authors.initials: RA
authors.lastname: Goulart
authors.forename: Francisco A
authors.initials: FA
authors.lastname: Garcia
authors.forename: Walter K
authors.initials: WK
authors.lastname: Kinney
authors.forename: L Stewart
authors.initials: LS
authors.lastname: Massad
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Mayeaux
authors.forename: Debbie
authors.initials: D
authors.lastname: Saslow
authors.forename: Mark
authors.initials: M
authors.lastname: Schiffman
authors.forename: Nicolas
authors.initials: N
authors.lastname: Wentzensen
authors.forename: Herschel W
authors.initials: HW
authors.lastname: Lawson
authors.forename: Mark H
authors.initials: MH
authors.lastname: Einstein
mesh_terms: D000328:Adult; D055088:Early Detection of Cancer / Q000379:methods*; D042241:Early Diagnosis; D005260:Female; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D055815:Young Adult