Clinical Commentary Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance ☆ Warner K. Huh a, ⁎, Kevin A. Ault b , David Chelmow c , Diane D. Davey d , Robert A. Goulart e , Francisco A.R. Garcia f , Walter K. Kinney g , L. Stewart Massad h , Edward J. Mayeaux i , Debbie Saslow j , Mark Schiffman k,1 , Nicolas Wentzensen k,1 , Herschel W. Lawson l , Mark H. Einstein m a University of Alabama at Birmingham, Birmingham, AL, USA b University of Kansas Medical Center, Kansas City, KS, USA c Virginia Commonwealth University Medical Center, Richmond, VA, USA d University of Central Florida, Orlando, FL, USA e New England Pathology Associates, Springfield, MA, USA f Pima County Health Department, Tucson, AZ, USA g Kaiser Permanente, Sacramento, CA, USA h Washington University School of Medicine, St. Louis, MO, USA i University of South Carolina School of Medicine, Columbia, SC, USA j American Cancer Society, Atlanta, GA, USA k National Cancer Institute, Bethesda, MD, USA l American Society of Colposcopy and Cervical Pathology, Frederick, MD, USA m Albert Einstein College of Medicine, Bronx, NY, USA HIGHLIGHTS • This interim guidance provides information for healthcare providers who are interested in primary hrHPV testing for cervical cancer screening. • Primary hrHPV screening can be considered as an alternative to current US cytology-based cervical cancer screening methods. • The potential advantages and disadvantages of this strategy are reviewed and discussed. abstract article info Article history: Received 10 November 2014 Accepted 15 December 2014 Available online xxxx 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 recommend- ed 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 Gynecolo- gists, 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 guid- ance 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 dis- advantages of this strategy for screening as well as to highlight areas in need of further investigation. © 2015 the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. Published by Elsevier Inc. All rights reserved. Gynecologic Oncology xxx (2015) xxx–xxx Please cite this article as: Huh WK, et al, Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance, Gynecol Oncol (2015), http://dx.doi.org/10.1016/j.ygyno.2014.12.022 ☆ This Interim Guidance is published simultaneously in Gynecologic Oncology, the Journal of Lower Genital Tract Disease and Obstetrics & Gynecology. ⁎ Corresponding author at: 1700 6th Avenue South, WIC Room 10250, Division of Gynecologic Oncology, Birmingham, AL 35233, USA. Fax: +1 205 975 6174. E-mail address: whuh@uabmc.edu (W.K. Huh). 1 The opinions expressed in this manuscript are those of the authors, not necessarily those of the US government. YGYNO-975741; No. of pages: 5; 4C: http://dx.doi.org/10.1016/j.ygyno.2014.12.022 0090-8258/© 2015 the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. Published by Elsevier Inc. All rights reserved. Contents lists available at ScienceDirect Gynecologic Oncology journal homepage: www.elsevier.com/locate/ygyno