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Reporting Results of Biomarker Testing of Specimens From Patients With Carcinoma of Gynecologic Origin: The Updated College of American Pathologists Protocol

  • 0From the Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston (Turashvili).
Archives of Pathology & Laboratory Medicine +

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September 16, 2025

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September 16, 2025

View abstract on PubMed

Summary

This summary is machine-generated.

The College of American Pathologists updated its Gynecologic Biomarker Protocol in 2024, incorporating new prognostic and therapeutic markers for gynecologic carcinomas. This revision enhances biomarker testing reporting and guidance for improved patient care.

Area Of Science

  • Pathology
  • Oncology
  • Molecular Diagnostics

Background

  • The College of American Pathologists (CAP) released the Gynecologic Biomarker Protocol in 2022.
  • Minor updates were made in 2023 for p53, human epidermal growth factor receptor 2 (HER2), and mismatch repair testing.
  • Recent advancements necessitated a major protocol revision in December 2024.

Purpose Of The Study

  • To update prognostic and therapeutic marker testing recommendations for gynecologic carcinomas.
  • To provide expanded explanatory notes and illustrative examples for biomarker testing.
  • To reflect recent developments in biomarker testing since the 2023 protocol.

Main Methods

  • A panel of gynecologic pathology experts convened by the CAP Cancer Committee.
  • Augmented existing biomarkers and introduced new ones.
  • Revised test reporting and explanatory notes based on current evidence and clinical guidelines.

Main Results

  • Updated hormone receptor testing recommendations.
  • Included subclonal loss of mismatch repair proteins and abnormal p53 expression.
  • Added programmed death ligand-1 (PD-L1) and folate receptor alpha testing, with revised HER2 testing and explanatory notes.

Conclusions

  • The updated CAP Gynecologic Biomarker Protocol offers enhanced structure and clarity for reporting prognostic/therapeutic biomarkers.
  • Comprehensive notes improve understanding of testing rationale, interpretation, and potential pitfalls.
  • The protocol aligns with the current standard of care for gynecologic carcinoma biomarker testing.