PD-L1 IHC 28-8 pharmDx for non-squamous NSCLC
The only FDA-approved test for PD-L1 expression associated with enhanced survival with OPDIVO? (nivolumab) for non-squamous NSCLC.
Demonstrated clinical results
PD-L1 IHC 28-8 pharmDx is a complementary diagnostic for PD-L1 expression in non-squamous NSCLC.
Patients with PD-L1 expression by all predefined expression levels in the OPDIVO group were associated with enhanced survival compared to docetaxel.
≥ 1% PD-L1 expression → 41% Reduction in Risk of Death (HR = 0.59) 17.1 months median OS vs. 9 months for docetaxel
≥ 5% PD-L1 expression → 57% Reduction in Risk of Death (HR = 0.43) 18.2 months median OS vs. 8.1 months for docetaxel
≥ 10% PD-L1 expression → 60% Reduction in Risk of Death (HR = 0.40) 19.4 months median OS vs. 8 months for docetaxel
PD-L1 testing is not required for the use of OPDIVO, but it will provide additional information for physicians and inform patient dialogue.
In patients with no PD-L1 expression (< 1%), survival with OPDIVO was similar to docetaxel.
Robust performance
Dako 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 and precision.
Selected analytical validation parameters |
Description |
Specificity |
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Primary antibody: rabbit monoclonal, clone 28-8
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Detects PD-L1 on the plasma membranes of tumor cells, the staining of which can be completely abolished by PD-L1 gene knock-out
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Detection in normal tissues is restricted to immune cells and infrequently the cells of epithelial origin
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Clone 28-8 exhibits no cross reactivity to PD-L2
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Sensitivity |
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Broad dynamic range of PD-L1 expression (0-100% tumor cells positive, 0-3 staining intensity) exhibited in study of 112 unique cases of non-squamous NSCLC archival FFPE specimens
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In BMS clinical study CA209057 of patients with non-squamous NSCLC, approximately 54% and 40% had PD-L1 expression levels ≥1% and ≥5%, respectively
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Repeatability |
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Repeatability testing of inter-instrument, inter-operator, inter-day, inter-lot and intra-run performance
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≥ 99% overall agreement for ≥ 1%, ≥ 5% and ≥ 10% expression levels
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95% confidence intervals ranged from 82.4 to 100% for NPA, PPA, and OA*
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Reproducibility |
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Reproducibility testing of day-to-day, site-to-site and observer-to-observer performance in a blinded study in three certified clinical labs
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≥ 94% overall agreement for ≥ 1% and ≥ 5% expression levels
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95% confidence intervals ranged from 78.5 to 100% for NPA, PPA, and OA
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* Negative Percent Agreement, Positive Percent Agreement, Overall Percent 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.
Order Information
Product |
Code |
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
PT100
|
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Product Information
Product details, specification sheet and safety data sheet (SDS).
Intended Use
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?.