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) cancer tissues using EnVision FLEX visualization system on Autostainer Link 48.
PD-L1 IHC 28-8pharmDx is indicated as an aid in identifying certain cancer patients for treatment with OPDIVO® (nivolumab).
PD-L1 IHC 28-8pharmDx is intended for use in specific types of cancer, which may vary by region. Please refer to the local Instructions for Use for a description of the types of cancer in which PD-L1 IHC 28-8 pharmDx is intended for use.PD-L1 IHC 28-8 pharmDx kit
The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides representing different expression levels of PD-L1 protein, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal rabbit antibody to PD-L1 and 50 slides incubated with the corresponding Negative Control Reagent, 100 slides in total).
For details on staining interpretation, refer to the Instructions for Use and indication-specific PD-L1 IHC 28-8 pharmDx Interpretation Manuals.
See the local OPDIVO® product label for approved indications and expression cut-off values to guide therapy.
PD-L1 IHC 28-8 pharmDx is subject to an exclusive trademark license to Agilent Technologies, Inc. OPDIVO® and YERVOY® are trademarks owned by Bristol-Myers Squibb.
For In Vitro Diagnostic Use.