CAP Updates Cancer Protocols to Refine Breast Cancer Biomarker Reporting and GIST Molecular Testing

Standardized biomarker reporting and molecular profiling are central to pathology-driven cancer care, but evolving practices require laboratories to keep reporting templates current. These templates capture information needed for diagnosis, staging, and treatment while aligning with expert guidance. To support this work, the College of American Pathologists has detailed Cancer Protocol updates addressing breast cancer biomarker reporting and gastrointestinal stromal tumor molecular testing.

The College of American Pathologists (CAP) has introduced revisions to 14 Cancer Protocols to align cancer reporting with evolving World Health Organization (WHO) classifications and advances in precision medicine. The Q3 release focuses on breast cancer biomarkers and gastrointestinal stromal tumors (GISTs). According to CAP, the updates reflect advances in precision oncology and laboratory accreditation.

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CAP’s Cancer Protocols are updated quarterly to incorporate guidance from leading standard-setting organizations, including the WHO and the American Joint Committee on Cancer (AJCC). These evidence-based tools are designed to help pathologists produce accurate, standardized reports that support diagnosis, staging, treatment decisions, and patient care. A full Summary of Revisions is available on cap.org.

Among the most significant changes, the Breast Phyllodes Tumor protocol is now required for accreditation when reporting malignant phyllodes tumors. The revised protocol incorporates WHO 6th Edition updates, modifies specific reporting elements, and updates staging and margin reporting. CAP notes that these changes are intended to bring reporting into closer alignment with current classifications.

The release also updates the Breast Biomarker Protocol, including revisions to estrogen receptor (ER), progesterone receptor (PgR), and HER2 scoring and reporting criteria. These changes are designed to support consistent reporting of biomarkers that help guide breast cancer treatment decisions. In addition, CAP expanded molecular testing and reporting capabilities within its GIST protocols, adding new reporting options for NTRK fusion gene analysis, enhancing KIT and PDGFRA testing and reporting, and supporting reporting for GISTs across all anatomic sites.

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