PD-L1 IHC 28-8 pharmDx Overview

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
• Linker, Anti-Rabbit

• Visualization Reagent-HRP
• DAB+ Substrate Buffer
• DAB+ Chromogen
• DAB Enhancer
• Control Slides

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 (nsNSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), melanoma, gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and esophageal carcinoma tissues using EnVision FLEX visualization system on Autostainer Link 48.

PD-L1 protein expression in nsNSCLC, SCCHN, UC, muscle invasive urothelial carcinoma (MIUC), melanoma, and esophageal squamous cell carcinoma (ESCC) is determined by using % tumor cell expression, which is the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity.

PD-L1 protein expression in 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 Indications

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^® (nivolumab).

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^® (nivolumab).

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

PD-L1 expression (≥ 1% or ≥ 5% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in melanoma may be used as an aid in the assessment of patients for whom OPDIVO^® (nivolumab) and YERVOY^® (ipilimumab) combination treatment is being considered.

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