Use of primary high-risk human papillomavirus testing for cervical cancer screening

Interim clinical guidance

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

Research output: Contribution to journalArticle

89 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)330-337
Number of pages8
JournalObstetrics and Gynecology
Volume125
Issue number2
DOIs
StatePublished - Feb 6 2015
Externally publishedYes

Fingerprint

Early Detection of Cancer
Uterine Cervical Neoplasms
Colposcopy
United States Food and Drug Administration
Cell Biology
Guidelines
Pathology
Expert Testimony
Health Personnel

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Medicine(all)

Cite this

Huh, W. K., Ault, K. A., Chelmow, D., Davey, D. D., Goulart, R. A., Garcia, F. A. R., ... Einstein, M. H. (2015). Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance. Obstetrics and Gynecology, 125(2), 330-337. https://doi.org/10.1097/AOG.0000000000000669

Use of primary high-risk human papillomavirus testing for cervical cancer screening : Interim clinical guidance. / Huh, Warner K.; Ault, Kevin A.; Chelmow, David; Davey, Diane D.; Goulart, Robert A.; Garcia, Francisco A R; Kinney, Walter K.; Massad, L. Stewart; Mayeaux, Edward J.; Saslow, Debbie; Schiffman, Mark; Wentzensen, Nicolas; Lawson, Herschel W.; Einstein, Mark H.

In: Obstetrics and Gynecology, Vol. 125, No. 2, 06.02.2015, p. 330-337.

Research output: Contribution to journalArticle

Huh, WK, Ault, KA, Chelmow, D, Davey, DD, Goulart, RA, Garcia, FAR, Kinney, WK, Massad, LS, Mayeaux, EJ, Saslow, D, Schiffman, M, Wentzensen, N, Lawson, HW & Einstein, MH 2015, 'Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance', Obstetrics and Gynecology, vol. 125, no. 2, pp. 330-337. https://doi.org/10.1097/AOG.0000000000000669
Huh, Warner K. ; Ault, Kevin A. ; Chelmow, David ; Davey, Diane D. ; Goulart, Robert A. ; Garcia, Francisco A R ; Kinney, Walter K. ; Massad, L. Stewart ; Mayeaux, Edward J. ; Saslow, Debbie ; Schiffman, Mark ; Wentzensen, Nicolas ; Lawson, Herschel W. ; Einstein, Mark H. / Use of primary high-risk human papillomavirus testing for cervical cancer screening : Interim clinical guidance. In: Obstetrics and Gynecology. 2015 ; Vol. 125, No. 2. pp. 330-337.
@article{5a01a1049e7d4a3e86e4ee95acfceb82,
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 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.",
author = "Huh, {Warner K.} and Ault, {Kevin A.} and David Chelmow and Davey, {Diane D.} and Goulart, {Robert A.} and Garcia, {Francisco A R} and Kinney, {Walter K.} and Massad, {L. Stewart} and Mayeaux, {Edward J.} and Debbie Saslow and Mark Schiffman and Nicolas Wentzensen and Lawson, {Herschel W.} and Einstein, {Mark H.}",
year = "2015",
month = "2",
day = "6",
doi = "10.1097/AOG.0000000000000669",
language = "English (US)",
volume = "125",
pages = "330--337",
journal = "Obstetrics and Gynecology",
issn = "0029-7844",
publisher = "Lippincott Williams and Wilkins",
number = "2",

}

TY - JOUR

T1 - Use of primary high-risk human papillomavirus testing for cervical cancer screening

T2 - Interim clinical guidance

AU - Huh, Warner K.

AU - Ault, Kevin A.

AU - Chelmow, David

AU - Davey, Diane D.

AU - Goulart, Robert A.

AU - Garcia, Francisco A R

AU - Kinney, Walter K.

AU - Massad, L. Stewart

AU - Mayeaux, Edward J.

AU - Saslow, Debbie

AU - Schiffman, Mark

AU - Wentzensen, Nicolas

AU - Lawson, Herschel W.

AU - Einstein, Mark H.

PY - 2015/2/6

Y1 - 2015/2/6

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84922419672&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84922419672&partnerID=8YFLogxK

U2 - 10.1097/AOG.0000000000000669

DO - 10.1097/AOG.0000000000000669

M3 - Article

VL - 125

SP - 330

EP - 337

JO - Obstetrics and Gynecology

JF - Obstetrics and Gynecology

SN - 0029-7844

IS - 2

ER -