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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), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), 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.

Tumor Indication*

Intended Use

PD-L1 Expression Clinical Cut off


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

≥1%, ≥5%, ≥10%




PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO®.



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®.


*For details on staining interpretation, refer to section 13 of the product insert and indication specific PD-L1 IHC 28-8 pharmDx Interpretation Manuals.

Key benefits of PD-L1 IHC 28-8 pharmDx
  • Broad Utility: Evidence based PD-L1 testing across multiple cancer types
  • Clinically relevant PD-L1 results linked to clinical outcomes
  • Unrivaled quality and reliability
  • Standardized and fully validated kit
  • The first and only FDA-approved test for multiple indications for OPDIVO
key benefits of pd
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
Urothelial carcinoma


PD-1/PD-L1 pathways
PD-1/PD-L1 pathways

Learn about the PD-1/PD-L1 pathways

Learn more

Kit Components

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 the kit:

Autostainer Link 48
EnVision FLEX Wash Buffer, 20x
EnVision FLEX Hematoxylin (Link)
PT Link
PT Link Rinse Station



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

2) Clinical Trial: CHECKMATE-057, CA209057

3) Clinical Trial: CHECKMATE-067, CA209067

4) Clinical Trial: CHECKMATE-141, CA209141

5) Clinical Trial: CHECKMATE-275, CA209275

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Product Information

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