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 (ns NSCLC) and squamous cell carcinoma of the head and neck (SCCHN) 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.Tumor indications*Squamous cell carcinoma of the head and neck (SCCHN)
PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in SCCHN is indicated as an aid in identifying SCCHN patients for treatment with OPDIVO® (nivolumab) and may be associated with enhanced survival from OPDIVO® (nivolumab). For companion diagnostic use.Non-squamous NSCLC
PD-L1 expression ≥ 1% tumor cell expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC, may be associated with enhanced survival from OPDIVO® (nivolumab).
*See the OPDIVO® product labels for specific clinical circumstances guiding PD-L1 testing.
PD-L1 IHC 28-8 pharmDx kitThe 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).
PD-L1 IHC 28-8 pharmDx is subject to an exclusive trademark license to Agilent Technologies, Inc. OPDIVO® is a trademark owned by Bristol-Myers Squibb.
Reg. Status: IVD
For In Vitro Diagnostic Use.