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.
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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?.
