Reporting Results of Biomarker Testing of Specimens From Patients With Carcinoma of Gynecologic Origin: The Updated College of American Pathologists Protocol
Context.—
The first version of the Template for Reporting Results of Biomarker Testing of Specimens From Patients With Carcinoma of Gynecologic Origin (hereafter referred to as the Gynecologic Biomarker Protocol) was released by the College of American Pathologists (CAP) in 2022. Minor updates included clarification of the content of p53 status and explanatory notes for human epidermal growth factor receptor 2 (HER2) and mismatch repair testing in 2023. Recent developments in biomarker testing have prompted a major update to this protocol, published in December 2024.
Objective.—
To assess prognostic and/or therapeutic markers since the release of the 2023 Gynecologic Biomarker Protocol and to update testing recommendations in gynecologic carcinomas, with expanded explanatory notes and illustrative examples provided in this article.
Design.—
The CAP Cancer Committee assembled a panel of experts subspecialized in gynecologic pathology to augment the existing biomarkers, add new biomarkers, expand test reporting, and revise explanatory notes based on available evidence and clinical practice guidelines such as those of the American Society of Clinical Oncology/CAP, National Comprehensive Cancer Network, and Society for Immunotherapy of Cancer.
Results.—
The changes to the Gynecologic Biomarker Protocol include updates to hormone receptors and addition of subclonal loss of mismatch repair proteins, subclonal abnormal p53 expression, programmed death ligand-1 (PD-L1) testing, and folate receptor alpha testing, as well as updates to HER2 testing and all explanatory notes.
Conclusions.—
The updated CAP Gynecologic Biomarker Protocol provides improved structure and clarity in the reporting of prognostic and/or therapeutic biomarkers and comprehensive explanatory notes that aid in understanding the rationale for testing, interpretive guidance, and common testing pitfalls, based on the current standard of care.
Contributor Notes
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Buza received scientific consultant fees from Astra Zeneca/Daiichi Sankyo, Agilent, and GlaxoSmithKline. Turashvili received scientific consultant fees from Astra Zeneca/Daiichi Sankyo. Hulkower and Hebert are employees of the College of American Pathologists. The other authors have no relevant financial interest in the products or companies described in this article.