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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 HPV (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 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 Gynecologists, 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 guidance 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 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.

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  • Authors+Show Affiliations

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    1University of Alabama at Birmingham, Birmingham, AL, USA; 2University of Kansas Medical Center, Kansas City, KS, USA; 3Virginia Commonwealth University Medical Center, Richmond, VA, USA; 4University of Central Florida, Orlando, FL, USA; 5New England Pathology Associates, Springfield, MA, USA; 6Pima County Health Department, Tucson, AZ, USA; 7Kaiser Permanente, Sacramento, CA, USA; 8Washington University School of Medicine, St. Louis, MO, USA; 9University of South Carolina School of Medicine, Columbia, SC, USA; 10American Cancer Society, Atlanta, GA, USA; 11National Cancer Institute, Bethesda, MD, USA; 12American Society of Colposcopy and Cervical Pathology, Frederick, MD, USA; and 13Albert Einstein College of Medicine, Bronx, NY, USA.

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    MeSH

    Adult
    Early Detection of Cancer
    Early Diagnosis
    Female
    Humans
    Molecular Diagnostic Techniques
    Papillomaviridae
    Practice Guidelines as Topic
    Prospective Studies
    Uterine Cervical Neoplasms
    Young Adult

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    25574659

    Citation

    Huh, Warner K., et al. "Use of Primary High-risk Human Papillomavirus Testing for Cervical Cancer Screening: Interim Clinical Guidance." Journal of Lower Genital Tract Disease, vol. 19, no. 2, 2015, pp. 91-6.
    Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. J Low Genit Tract Dis. 2015;19(2):91-6.
    Huh, W. K., Ault, K. A., Chelmow, D., Davey, D. D., Goulart, R. A., Garcia, F. A., ... Einstein, M. H. (2015). Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Journal of Lower Genital Tract Disease, 19(2), pp. 91-6. doi:10.1097/LGT.0000000000000103.
    Huh WK, et al. Use of Primary High-risk Human Papillomavirus Testing for Cervical Cancer Screening: Interim Clinical Guidance. J Low Genit Tract Dis. 2015;19(2):91-6. PubMed PMID: 25574659.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Use of primary high-risk human papillomavirus testing for cervical cancer screening: 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, 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 - 2015/1/10/entrez PY - 2015/1/13/pubmed PY - 2016/3/2/medline SP - 91 EP - 6 JF - Journal of lower genital tract disease JO - J Low Genit Tract Dis VL - 19 IS - 2 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 HPV (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 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 Gynecologists, 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 guidance 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 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. SN - 1526-0976 UR - https://www.unboundmedicine.com/medline/citation/25574659/Use_of_primary_high_risk_human_papillomavirus_testing_for_cervical_cancer_screening:_interim_clinical_guidance_ L2 - http://Insights.ovid.com/pubmed?pmid=25574659 DB - PRIME DP - Unbound Medicine ER -