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

    Authors

    W. K. Huh; K. A. Ault; D. Chelmow; D. D. Davey; R. A. Goulart; F. A. R. Garcia; W. K. Kinney; L. S. Massad; E. J. Mayeaux; D. Saslow; M. Schiffman; N. Wentzensen; H. W. Lawson;M. H. Einstein

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    Abbreviated Journal Title

    Obstet. Gynecol.

    Keywords

    LIQUID-BASED CYTOLOGY; FOLLOW-UP; WOMEN; TRIAL; COLPOSCOPY; PREVENTION; SERVICES; FINLAND; Obstetrics & Gynecology

    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 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.

    Journal Title

    Obstetrics and Gynecology

    Volume

    125

    Issue/Number

    2

    Publication Date

    1-1-2015

    Document Type

    Article

    Language

    English

    First Page

    330

    Last Page

    337

    WOS Identifier

    WOS:000348595500008

    ISSN

    0029-7844

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