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 melanoma 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, as defined by the specific tumor indication interpretation guidelines in the instructions for use (IFU).Non-small cell lung cancerNSCLC - Companion Diagnostic Indication
Detection of PD-L1 expressing in tumor cells by PD-L1 IHC 28-8 pharmDx in NSCLC patient specimens is associated with an overall survival benefit from OPDIVO® (nivolumab) + YERVOY® (ipilimumab) treatment for patients for first-line treatment at PD-L1 expression clinical cutoff ≥ 1% tumor cell expression.Non-squamous non-small cell lung cancer (nsNSCLC)
PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab).Melanoma
Positive PD-L1 status as determined 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.SCCHN
PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab).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).
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.
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For In Vitro Diagnostic Use.