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Practice Guideline
. 2025 Apr 1;29(2):134-143.
doi: 10.1097/LGT.0000000000000865. Epub 2025 Jan 10.

Applying Results of Extended Genotyping to Management of Positive Cervicovaginal Human Papillomavirus Test Results: Enduring Guidelines

L Stewart Massad  1 , Megan A Clarke  2 , Rebecca B Perkins  3 , Francisco Garcia  4 , David Chelmow  5 , Li C Cheung  2 , Teresa M Darragh  6 , Didem Egemen  2 , Thomas S Lorey  7 , Ritu Nayar  8 , Morgan Newman  9 , Carolann Risley, Robert A Smith  10 , Nicolas Wentzensen  2 ; Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee
Affiliations
Practice Guideline

Applying Results of Extended Genotyping to Management of Positive Cervicovaginal Human Papillomavirus Test Results: Enduring Guidelines

L Stewart Massad et al. J Low Genit Tract Dis. .

Abstract

Objective: The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for the use of extended genotyping results in cervical cancer prevention programs.

Methods: Risks of cervical intraepithelial neoplasia grade 3 or worse were calculated using data obtained with the Onclarity HPV Assay from large cohorts. Management recommendations were based on clinical action thresholds developed for the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines. Risk estimates were reviewed in relation to clinical action thresholds and used as the basis for draft recommendations. After an open comment period, recommendations were finalized and ratified through a vote by the Consensus Stakeholder Group.

Results: Colposcopy is recommended after positive tests for human papillomavirus (HPV) types 16 and 18. For those positive for HPV 45, 33/58, 31, 52, 35/39/68, or 51 but negative for 16 or 18, triage with cytology or dual stain testing is recommended. When screening with primary HPV testing, for patients who test positive for HPV types 56/59/66 and no other carcinogenic types, repeat HPV testing in 1 year is recommended. When screening with cotesting, for those who test positive for HPV types 56/59/66 and no other carcinogenic types, 1-year return is recommended for negative for intraepithelial lesion or malignancy, atypical squamous cells of undetermined significance, and low-grade squamous intraepithelial lesion, and colposcopy is recommended for atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H), atypical glandular cells, high-grade squamous intraepithelial lesion, or carcinoma. When patients without prior high-grade cytology (atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion, atypical glandular cells, high-grade squamous intraepithelial lesion, or carcinoma) or histology (cervical intraepithelial neoplasia [CIN]2, CIN3, or adenocarcinoma in situ) are being followed, use of extended genotyping results is acceptable. When high-grade cytology or histology results are present, or when patients are being followed after treatment of CIN2+, management using the 2019 guidelines is recommended.

Conclusions: Human papillomavirus extended genotyping can guide clinical management in the setting of a positive HPV test result.

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Conflict of interest statement

L.S.M. participated in an HPV vaccine call with Merck. N.B. has served on an advisory board for Merck. D.C. is a member of the United States Preventive Services Task Force (USPSTF); this article does not necessarily represent the views and policies of the USPSTF. D.C. was recused from development of recommendations related to screening and fully participated in recommendations related to diagnosis and management. M.E. has served as a consultant for Papivax, Merck, BD, PDS. R.G. has served as a consultant for Inovio. D.H. has served as a consultant for Roche. W.H. has served as a consultant for Roche, SeeGene, and AstraZeneca. R.N. has participated in an educational meeting supported by Roche. M.C. reports legal work for Merck. The other authors have declared they have no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Type configurations of human papillomavirus (HPV) assays approved by the Food and Drug Administration as of May 2024.
See this image and copyright information in PMC

References

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