The only FDA-approved test for PD-L1 expression associated with enhanced survival with OPDIVO® (nivolumab) for non-squamous NSCLC.
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.
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|
* 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.
|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®.