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• W2897438212 abstract "The College of American Pathologists (CAP) formulated a guideline1 in 2014 on immunohistochemistry in predictive testing containing the following expert consensus opinion: “For initial analytic validation of all laboratory-developed predictive marker assays laboratories should test a minimum of 20 positive and 20 negative cases. When the laboratory medical director determines that fewer than 40 validation cases are sufficient for a specific marker, the rationale for that decision needs to be documented.” Other guidelines2 do not touch upon this issue or are not as explicit. In the CAP guideline a case is summarized as one analyte and classified as either positive or negative. As a clinical pathologist (Dutch terminology), I wonder whether a case is one analyte (like a blood test) or a composite of several hundreds or thousands of analytes (depending on sample size), represented by individual (tumor) cells.If the immunohistochemical test shows a homogeneous distribution in all tumor cells, a case can be summarized unequivocally as either negative or positive. In this sense a case can be considered as one analyte. However, 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. Likewise, some tumor cells may show PD-L1 expression with a higher intensity, whereas others may be less strongly stained.Commercial assays are usually more expensive than laboratory-developed tests (LDTs). Of course, clinical validation of predictive LDTs is obligatory. However, sufficient detailed information on how to validate a concept LDT has so far not been provided.8,9Basically, comparison with a compendium diagnostic test that was clinically validated in a phase 3 study10 is the way forward. In lung cancer, the only compendium diagnostic test is the 22C3 assay from Agilent, coupled to pembrolizumab.10,11To this end, critical samples, which have an epitope concentration close to the threshold of the validated assay,12,13 are suitable. A practical approach is to stain the concept LDT and compendium diagnostic test in a pairwise fashion on approximately 20 consecutive clinical samples. If both assays are not too deviant, approximately 80% to 90% of the samples will be concordant throughout the entire slide. The 2 or 3 samples that show at least focal discordancy (read also focal differences in intensity) can be used for further titration of the LDT; for example, by increasing or reducing the primary antibody concentration, equal staining intensity in the initially discordant areas can be achieved. However, if the deviation between both PD-L1 assays is larger, usually the concept LDT stains less intensely or not at all compared with the commercial assay; more samples are available for further improvement of the concept LDT, and more rigorous adaptions may then also be considered, such as modifying the signal enhancement system. To facilitate this process, tissue management is helpful14: that is, cutting upfront several spare sections for additional PD-L1 testing. Subsequently, the repeated testing on suitable samples can be performed within a few days/weeks after initial cutting.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." @default.
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• W2897438212 date "2018-10-11" @default.
• W2897438212 modified "2023-10-11" @default.
• W2897438212 title "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" @default.
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• W2897438212 doi "https://doi.org/10.5858/arpa.2018-0410-ed" @default.
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