The first and only FDA approved PD-L1 test for use in the assessment of the magnitude of treatment effect on progression free survival in melanoma patients from OPDIVO.
PD-L1 IHC 28-8 pharmDx demonstrated clinical results in the phase 3 CheckMate-067 clinical trial.
The CheckMate -067 study was a three armed study of OPDIVO® (nivolumab) monotherapy or OPDIVO in combination with YERVOY® (ipilimumab) versus YERVOY monotherapy
PFS was evaluated across PD-L1 subgroups at 1% as a pre-planned retrospective analysis (secondary objective)
The magnitude of the treatment effect on progression-free survival from OPDIVO is correlated with positive PD-L1 status as determined by PD-L1 IHC 28-8 pharmDx in melanoma.
PD-L1 IHC 28-8 pharmDx is FDA approved and fully validated with analytical performance having met all pre-determined acceptance criteria for sensitivity, specificity, repeatability, and reproducibility.
|Selected analytical validation parameters||Results for metastatic melanoma|
*Average Negative Agreement, Average Positive Agreement, and Overall Agreement
Reference 2) Phillips T, Simmons P, Inzunza H, Cogswell J, Novotny J, Taylor C, Zhang X. Development of an automated PD-L1 immunohistochemistry (IHC) assay for non.small cell lung cancer. Appl Immunohistochem Mol Morph 2015;8:541-9.
|PD-L1 IHC 28-8 pharmDx||SK005|
Required but not included in kit:
Autostainer Link 48
EnVision FLEX Wash Buffer, 20x
EnVision FLEX Hematoxylin (Link)
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Product details, specification sheet and safety data sheet (SDS).
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-squamous non small cell lung cancer (NSCLC) and melanoma tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity.
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) treatment.
Positive PD-L1 status as determined by PD-L1 IHC 28-8 pharmDx in melanoma is correlated with the magnitude of the treatment effect on progression-free survival from OPDIVO®.