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PD-L1 IHC 28-8 pharmDx Melanoma Interpretation

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PD-L1 IHC 28-8 pharmDx for melanoma

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 intensity.

Interpretation manual

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<1% of the viable tumor cells exhibit complete circumferential or partial linear plasma membrane staining at any intensity.

PD-L1 expression < 1%

≥1% of the viable tumor cells exhibit complete circumferential or partial linear plasma membrane staining at any intensity.

PD-L1 expression ≥1%

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), head and neck cancer (HNC), 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.

To measure the proportion of PD-L1 expression in cancer tissue or cells.

  • Indicated as an aid for proper administration of nivolumab [recombinant] in non-squamous non-small cell lung cancer [NSCLC] patients and head and neck cancer (HNC) patients.
  • Indicated as an aid for proper administration of nivolumab and ipilimumab combination in melanoma patients.1