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Related Experiment Video

Updated: Mar 26, 2026

Chromogenic In Situ Hybridization as a Tool for HPV-Related Head and Neck Cancer Diagnosis
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Evaluating HPV-negative CIN2+ in the ATHENA trial.

Karl Ulrich Petry1, J Thomas Cox2, Kristin Johnson3

  • 1Department of Obstetrics and Gynecology, Klinikum Wolfsburg, Wolfsburg, Germany.

International Journal of Cancer
|February 7, 2016
PubMed
Summary

This study investigated if Human Papillomavirus (HPV)-negative cervical lesions are truly HPV-negative. Findings suggest that high-grade cervical lesions (CIN3/ACIS) are consistently linked to HPV, even in initially negative tests.

Keywords:
HPV DNA testingHPV genotypeadenocarcinoma in situcervical cancer screeningcervical intraepithelial neoplasiahistology

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Area of Science:

  • Gynecology
  • Oncology
  • Virology

Background:

  • Cervical cancer screening relies heavily on Human Papillomavirus (HPV) testing.
  • The existence and clinical relevance of true HPV-negative cervical lesions remain a subject of investigation.

Purpose of the Study:

  • To determine if true HPV-negative cervical intraepithelial neoplasia grade 2 or worse (CIN2+) lesions exist.
  • To assess the clinical relevance of such lesions in cervical cancer screening.

Main Methods:

  • Post hoc analysis of the ATHENA study database.
  • Comparison of HPV test results (cobas HPV, Linear Array, Amplicor) for CIN2+ cases.
  • p16 immunostaining and histopathology re-review for false-positive histology.
  • Whole tissue section HPV PCR for confirmation of HPV status.

Main Results:

  • Of 497 CIN2+ cases, 55 were initially cobas HPV-negative.
  • 32 of these were positive by other HPV tests (false-negatives for cobas HPV), with 9 of 12 CIN3/ACIS being p16+.
  • 23 cases were negative by all HPV tests; 7 of 11 CIN3/ACIS were p16+.
  • HPV PCR on confirmed CIN3/ACIS cases revealed oncogenic genotypes in 2 of 7, non-oncogenic in 4, and indeterminate in 1.

Conclusions:

  • Subanalysis of a large cervical cancer screening study did not identify any true CIN3/ACIS not attributable to HPV.
  • The findings support the high sensitivity of current HPV testing methods in detecting clinically relevant cervical lesions.