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PD-L1 IHC 28-8 pharmDx SCCHN Interpretation Manual

More personalized cancer results. One test makes it possible.

To assess the PD-L1 expression level in patient slides stained with PD-L1 IHC 28-8 pharmDx, pathologists should determine the percentage of viable tumor cells exhibiting partial linear or complete circumferential plasma membrane staining at any staining intensity.

Interpretation Manual

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References

  1. PD-L1 IHC 28-8 pharmDx Instructions for Use

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Intended Use

For in vitro diagnostic use

PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), and melanoma tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. Tumor PD-L1 status is defined by indication specific staining interpretation.