PD-L1 IHC 28-8 pharmDx Non-squamous NSCLC Interpretation Manual

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 or complete linear circumferential plasma membrane staining at any staining intensity.

Interpretation Manual

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Staining pattern	Examples of non-squamous NSCLC	Examples of result reporting
< 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%
≥ 5% of the viable tumor cells exhibit complete circumferential or partial linear plasma membrane staining at any intensity.		PD-L1 expression ≥ 5%
≥ 10% of the viable tumor cells exhibit complete circumferential or partial linear plasma membrane staining at any intensity.		PD-L1 expression ≥ 10%

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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) and melanoma tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity.

PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab) treatment.

Positive PD-L1 status as determined by PD-L1 IHC 28-8 pharmDx in melanoma is correlated with the magnitude of the treatment effect on progression-free survival from OPDIVO®.