Melanoma
PD-L1 IHC 28-8 pharmDx for Autostainer Link 48
CE-IVD
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), melanoma, urothelial carcinoma (UC), muscle invasive urothelial cancer (MIUC), gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, esophageal adenocarcinoma, and esophageal squamous cell carcinoma (ESCC) tissues using EnVision FLEX visualization system on Autostainer Link 48.
PD-L1 protein expression in nsNSCLC, SCCHN, UC, MIUC, melanoma, and ESCC 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).
Esophageal squamous cell carcinoma
PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying ESCC patients for treatment with OPDIVO® (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy or OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab) as a companion diagnostic test.
Gastric, GEJ, and esophageal adenocarcinoma
PD-L1 expression (CPS ≥ 5) as detected by PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying gastric, gastroesophageal junction, or esophageal adenocarcinoma patients for treatment with OPDIVO® (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy.
Non-squamous NSCLC (nsNSCLC)
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).
SCCHN
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).
Melanoma
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.
Urothelial carcinoma (UC)
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).
Muscle invasive urothelial cancer (MIUC)
PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying MIUC patients for treatment with OPDIVO® (nivolumab) as a companion diagnostic test.
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 registered trademarks owned by Bristol-Myers Squibb.
Read more about PD-L1 IHC 28-8 pharmDx.
Interpretation training is now available for PD-L1 IHC 28-8 pharmDx
To learn more, visit PD-L1 IHC 28-8 pharmDx eLearning.
For In Vitro Diagnostic Use.
Product Details
Featured References
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