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How to Validate Predictive Immunohistochemistry Testing in Pathology? A Practical Approach Exploiting the Heterogeneity of Programmed Death Ligand-1 Present in Non–Small Cell Lung Cancer
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How to Validate Predictive Immunohistochemistry Testing in Pathology? A Practical Approach Exploiting the Heterogeneity of Programmed Death Ligand-1 Present in Non–Small Cell Lung Cancer
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Journal Article
How to Validate Predictive Immunohistochemistry Testing in Pathology? A Practical Approach Exploiting the Heterogeneity of Programmed Death Ligand-1 Present in Non–Small Cell Lung Cancer
2019
Overview
[...]in programmed death ligand-1 (PD-L1) immunohistochemistry of non-small cell lung cancer, heterogeneity is frequently present,3-7 implying that some of the tumor cells may be negative and other tumor cells, not far from each other, positive. Of note: (1) the focal initially discordant area probably contains several tumor cells with different epitope concentrations (individual analytes, usually within a factor 2-4 concentration range15), facilitating calibration of both assays; (2) the samples with concordant positivity, even in initially very deviant assays, prove the point that samples with high epitope concentration are not suitable for calibration or for daily monitoring of immunohistochemistry; (3) needless to say, participation in external quality assessment schemes after internal validation of the predictive assay is obligatory16; and (4) the number of samples to stain is fewer than published in the above-mentioned CAP guideline1 because critical samples have in one case sufficient relevant cells as individual analytes, providing the rationale for the laboratory medical director to test fewer than 40 cases for indirect clinical validation in predictive testing. Programmed death-ligand 1 immunohistochemistry testing: a review of analytical assays and clinical implementation in non-small-cell lung cancer.
Publisher
College of American Pathologists
