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.
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.
