PD-L1 IHC 28-8 pharmDx Overview

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).

PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in melanoma may be used as an aid in the assessment of patients for whom OPDIVO® (nivolumab) and YERVOY® (ipilimumab) combination treatment is being considered.¹

• The only CE-IVD marked test for PD-L1 expression associated with enhanced survival with OPDIVO for non-squamous NSCLC.^{1, 2}
• The first and only CE-IVD marked PD-L1 test for use in the assessment of patients for whom OPDIVO® (nivolumab) and YERVOY® (ipilimumab) combination treatment is being considered in melanoma.³

• Integrate PD-L1 IHC 28-8 pharmDx without changing staining lab workflow
• Ready-to-use reagents and cell line controls optimized for Autostainer Link 48
• Pre-programmed, validated protocol

Non-squamous NSCLC
Melanoma

Read about the interpretation of PD-L1 IHC 28-8 pharmDx staining results.

Interpretation of non-squamous NSCLC staining results
Interpretation of melanoma staining results

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Learn about the PD-1/PD-L1 pathways

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Dako PD-L1 IHC 28-8 pharmDx is a complete kit with reagents sufficient for 50 tests (50 slides incubated with primary antibody to PD-L1 and 50 slides incubated with the corresponding negative control reagent) and 15 Control Slides for use on Autostainer Link 48.

• EnVision FLEX Target Retrieval Solution, Low pH, 50x
• Peroxidase-Blocking Reagent
• Monoclonal Rabbit Anti-PD-L1, Clone 28-8
• Negative Control Reagent
• PD-L1 IHC 28-8 pharmDx Rabbit LINKER
• Visualization Reagent-HRP
• DAB+ Substrate Buffer
• DAB+ Chromogen
• DAB Enhancer
• Control Slides

Product	Code
PD-L1 IHC 28-8 pharmDx	SK005
Required but not included in kit: Autostainer Link 48 EnVision FLEX Wash Buffer, 20x EnVision FLEX Hematoxylin (Link) PT Link	AS480 K8007 K8008 PT101

1) PD-L1 IHC 28-8 pharmDx Instruction For Use

2) Clinical Trial: Checkmate 057, CA209057

3) Clinical Trial: Checkmate 067, CA209067