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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
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-small cell lung cancer (NSCLC)

Click here to download Manual and Brochure

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?

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Scoring Guidelines

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

Coming soon - Interpretation of NSCLC 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

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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-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.

Companion Diagnostic Indication

Tumor Indication

PD-L1 Expression Clinical
Cut-Off

Intended Use

NSCLC

≥ 1% tumor cell expression

PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).

PD-L1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO®.

PD-L1 expression (≥ 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO®.

PD-L1 expression (≥ 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO®.

See the OPDIVO® and YERVOY® product labels for specific clinical circumstances guiding PD-L1 testing.

References

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

2. CHECKMATE-227, CA209227

3. CHECKMATE-057, CA209057

4. CHECKMATE-141, CA209141

5. CHECKMATE-275, CA209275