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 |
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Analytical Specificity |
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Sensitivity |
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Repeatability |
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External Reproducibility |
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*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.
Product | Code |
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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) PT Link |
AS480 K8007 K8008 PT101 |
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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®.