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Use of Primary High-Risk Human Papillomavirus Testing for Cervical Cancer Screening

Interim Clinical Guidance

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

doi: 10.1097/AOG.0000000000000669
Contents: Guidelines

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 human papillomavirus [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 U.S.-based registration study. Thirteen experts, including representatives from the Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the 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 U.S. Food and Drug Administration (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.

This interim guidance aims to provide information for health care providers who are interested in primary human papillomavirus testing.

University of Alabama at Birmingham, Birmingham, Alabama; the University of Kansas Medical Center, Kansas City, Kansas; Virginia Commonwealth University Medical Center, Richmond, Virginia; the University of Central Florida, Orlando, Florida; New England Pathology Associates, Springfield, Massachusetts; Pima County Health Department, Tucson, Arizona; Kaiser Permanente, Sacramento, California; Washington University School of Medicine, St. Louis, Missouri; University of South Carolina School of Medicine, Columbia, South Carolina; American Cancer Society, Atlanta, Georgia; the National Cancer Institute, Bethesda, Maryland; the American Society of Colposcopy and Cervical Pathology, Frederick, Maryland; and Albert Einstein College of Medicine, Bronx, New York.

Corresponding author: Warner K. Huh, MD, 1700 6th Avenue South, WIC Room 10250, Division of Gynecologic Oncology, Birmingham, AL 35233; e-mail:

This Interim Guidance is published simultaneously in Gynecologic Oncology, the Journal of Lower Genital Tract Disease, and Obstetrics & Gynecology.

The opinions expressed in this article are those of the authors, not necessarily those of the U.S. government.

Financial Disclosure Dr. Huh is on the scientific advisory board of Merck. While at Emory University, Dr. Ault was the site principle investigator for clinical trials sponsored by Merck, Hologic, Roche, and Gen Probe; all payments for the research went to the university. Dr. Ault also has been a consultant to the National Cancer Institute and the American College of Obstetricians and Gynecologists but has not received any payment for these activities. Dr. Garcia was the principle investigator for the 2012 contract between the University of Arizona and Ventana Medical. The contract had a $100,000 value, but Dr. Garcia received no personal compensation. Dr. Schiffman has received assays at no cost from Roche and BD for National Cancer Institute research under his control. Dr. Einstein has advised or participated in educational speaking activities but does not receive an honorarium from any companies. In specific cases, his hospital, Montefiore Medical Center, has received payment for time spent for these activities from Merck, GSK, Roche, Bristol-Myers Squibb, Photocure, Hologic, Cepheid, and PDS Biotechnologies. If travel is required for meetings with any industry, the company pays for Dr. Einstein’s travel-related expenses. Also, Montefiore Medical Center has received grant funding for research-related costs of clinical trials for which Dr. Einstein has been the overall principle investigator or the Montefiore principle investigator from Merck, GSK, Roche, Photocure, Inovio, Endocyte, Fujiboro, Eli Lilly, PDS Biotechnologies, Becton-Dickinson, Cepheid, and Hologic. The other authors did not report any potential conflicts of interest.

© 2015 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.