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PD-L1 IHC 28-8 pharmDx Overview

More Personalized Cancer Results. One Test Makes it Possible.
Agilent Dako
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
Product Information

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

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 non-small cell lung cancer (nsNSCLC)

Click here to download Manual and Brochure

Squamous cell carcinoma of the head and neck (SCCHN)

Click here to download Manual and Brochure

Urothelial carcinoma (UC)

Click here to download Manual and Brochure

pd l1 ihc workflow teaser image Want to hear more about PD-L1 IHC 28-8 pharmDx?

Contact your local sales representative.

PD-L1 IHC 22C3 pharmDx product teaser image

Scoring Guidelines

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

Interpretation of non-squamous NSCLC staining results

Interpretation of SCCHN staining results

Interpretation of UC staining results

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

PD-L1 IHC 22C3 pharmDx product teaser image

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.

Kit components teaser image
  • 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

AS480

K8007

K8008

PT101/PT200

PT109

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), and urothelial carcinoma (UC) 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*

PD-L1 Expression Clinical Cut off

Intended Use

nsNSCLC

≥1%, ≥5%, ≥10%

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).

SCCHN

≥1%

UC

≥1%

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

References

1. PD-L1 IHC 28-8 pharmDx Instructions for Use

2. Clinical Trial: CHECKMATE-057, CA209057

3. Clinical Trial: CHECKMATE-141, CA209141

4. Clinical Trial: CHECKMATE-275, CA209275