- 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
- 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
Esophageal squamous cell carcinoma (ESCC)
Click here to download Manual and Brochure
Gastric, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma
Click here to download Manual and Brochure
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)
Read about the interpretation of PD-L1 IHC 28-8 pharmDx staining results.
Interpretation of ESCC staining results
Interpretation of Gastric, GEJ, or esophageal adenocarcinoma staining results
Interpretation of NSCLC staining results
Interpretation of non-squamous NSCLC staining results
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
|
Product |
Code |
|---|---|
|
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), urothelial carcinoma (UC), gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and esophageal carcinoma tissues using EnVision FLEX visualization system on Autostainer Link 48.
PD-L1 protein expression in NSCLC, SCCHN, and UC is determined by the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity.
PD-L1 protein expression in esophageal squamous cell carcinoma (ESCC), gastric adenocarcinoma, GEJ adenocarcinoma, and esophageal adenocarcinoma is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
Companion Diagnostic Indication
|
Tumor Indication |
PD-L1 Expression Level |
Therapy |
|
NSCLC |
% Tumor Cell Expression ≥ 1% |
OPDIVO® (nivolumab) |
|
ESCC |
CPS ≥ 1 |
OPDIVO® (nivolumab) or OPDIVO QVANTIG® (nivolumab and hyaluronidase-nvhy) |
|
Gastric, GEJ, or Esophageal Adenocarcinoma |
CPS ≥ 1 |
When used in accordance with approved therapeutic labeling:
PD-L1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC (nsNSCLC) 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 and enhanced disease-free survival from OPDIVO®.
See the OPDIVO® and OPDIVO QVANTIG® product labels for specific clinical circumstances guiding PD-L1 testing.
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