What Lab Leaders Need to Know About the Latest CAP Cancer Protocol Updates
New CAP cancer protocol updates bring key biomarker changes—what lab leaders need to know to stay compliant, current, and clinically aligned.
As a lab leader, ensuring your team remains aligned with the most current standards is critical to maintaining diagnostic excellence and meeting clinical demands. The College of American Pathologists (CAP) recently released its Q3 updates to 10 cancer protocols, with a strong focus on biomarker revisions that are central to patient care and treatment planning. These updates reflect CAP’s commitment to “accurate, standardized cancer reporting” and alignment with evolving guidelines from the American Joint Committee on Cancer (AJCC) and the World Health Organization (WHO).
Key Changes in Biomarker Reporting
One of the most impactful updates is in the Lung, Biomarker Protocol, which now reflects the growing role of precision oncology. CAP has expanded molecular profiling to include updates on BRAF, NTRK, NRG1, and Tumor Mutational Burden. These enhancements are designed to support broader and more relevant genomic testing. For labs striving to deliver comprehensive molecular diagnostics, this is a significant shift that calls for potential workflow and test menu evaluations.
In the GYN, Biomarker Protocol, CAP introduces more flexibility while tightening standards where necessary:
- “All immunohistochemical (IHC) tests are now optional”, a change from the previous requirement, offering labs greater discretion based on case specifics.
- However, for HER2 testing, there’s a new required element: “HER2 In Situ Hybridization Testing Status is now a required element when reporting Equivocal (score 2+) protein overexpression in HER2 Status for Trastuzumab use.” This ensures precise treatment decisions, particularly in borderline cases.
- Additionally, CAP now mandates reporting the “MLH1 Promoter Methylation Analysis Status” when there’s a loss of nuclear expression of MLH1 and PMS2 in MMR IHC interpretation—an important step toward standardizing Lynch syndrome assessment.
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General Biomarker Reporting Enhancements
The update also revises General IHC Quantitative Biomarkers, providing more comprehensive and customizable reporting tools. Newly introduced optional data elements include:
- Cold Ischemic Time
- Fixative
- Fixation Time
- Membranous Staining Intensity
These additions allow labs to include more detailed pre-analytic and analytic variables when needed. CAP also improves clarity by offering expanded reporting options for internal controls and removing ambiguity. Notably, they have “removed the ‘(indeterminate)’ parenthetical for ‘Cannot be determined’ answers,” which better distinguishes between uncertain and genuinely unreportable results.
Beyond Biomarkers: Protocol Revisions Across Specialties
The Q3 update extends beyond biomarkers, with revised protocols in several high-impact areas:
- Lung resection protocols
- Ophthalmic cancers
- Central nervous system tumors
- Hematologic malignancies
These changes aim to integrate the latest research and clinical consensus into routine cancer diagnostics. As always, a full Summary of Revisions is available at cap.org.
What This Means for Lab Leaders
For lab directors and pathology team leaders, these updates aren’t just technical, they’re strategic. Implementing them ensures compliance, enhances diagnostic accuracy, and positions your lab as a partner in precision oncology. Leaders should:
- Review and update standard operating procedures considering new required elements.
- Educate pathologists and molecular staff about changes, especially those affecting interpretation and reporting.
- Coordinate with IT or LIS teams to integrate optional data fields where useful.
In short, staying current with CAP protocols isn’t just about meeting accreditation standards, it’s about delivering the best possible care through high-quality diagnostics.
—Janette Wider
