Northfield, Ill. (September 17, 2025)— The College of American Pathologists (CAP) released updates to 10 cancer protocols, with several key changes impacting biomarker sections critical for guiding patient care. This quarterly update ensures pathologists, oncologists, and laboratories have the most up-to-date tools to support accurate, standardized cancer reporting while aligning with the latest standards from the American Joint Committee on Cancer and the World Health Organization.
Key Biomarker Updates:
- Lung, Biomarker Protocol: Expanded molecular profiling with updates/additions to BRAF, NTRK, NRG1, and Tumor Mutational Burden reporting.
- GYN, Biomarker Protocol:
- All immunohistochemical (IHC) tests are now optional (previously required).
- HER2 In Situ Hybridization Testing Status is now a required element when reporting Equivocal (score 2+) protein overexpression in HER2 Status for Trastuzumab use.
- MLH1 Promoter Methylation Analysis Status is now required when reporting loss of nuclear expression of MLH1 and PMS2 in IHC Interpretation for Mismatch Repair (MMR) Proteins.
- General IHC Quantitative Biomarkers:
- Optional data elements added for Cold Ischemic Time, Fixative, Fixation Time, and Membranous Staining Intensity.
- Expanded reporting options for internal controls.
- Removal of the “(indeterminate)” parenthetical for “Cannot be determined” answers.
These biomarker updates enhance clarity, flexibility, and precision in cancer reporting, allowing pathologists to better tailor information to clinical needs. By incorporating the latest evidence-based standards, CAP Cancer Protocols continue to support excellence in cancer diagnosis and treatment planning.
In addition to the biomarker enhancements, the Q3 release includes revisions to lung resection protocols, ophthalmic cancer protocols, and central nervous system and hematologic cancer protocols. A full Summary of Revisions is available at cap.org.
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About the Collee of American Pathologists
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.