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PD-L1 IHC 28-8 pharmDx Overview

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®.

Key benefits of PD-L1 IHC 28-8 pharmDx
  • The only FDA-approved test for PD-L1 expression associated with enhanced survival with OPDIVO for non-squamous NSCLC
  • The first and only FDA approved PD-L1 test for use in the assessment of the magnitude of treatment effect on progression free survival in melanoma patients from OPDIVO
Experience the easy integration of PD-L1 in your IHC workflow
  • 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

Scoring Guidelines

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

Sign up now for new interactive online PD-L1 interpretation program

The CTLA-4 and PD-1/PD-L1 pathways

Learn about the CTLA-4 and PD-1/PD-L1 pathways

Learn more

Kit Components

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

Order Information
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





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Product Information

Product details, specification sheet and safety data sheet (SDS).


Non-squamous NSCLC


Interpretation Manual



Interpretation Manual