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) 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®.

• 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

• 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

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

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

Learn more

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