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
• PD-L1 IHC 28-8 pharmDx Rabbit LINKER

• 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-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