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Obstet Gynecol. 2015 Feb;125(2):330-7. doi: 10.1097/AOG.0000000000000669.

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

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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.


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.

[Indexed for MEDLINE]

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