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PD-L1 IHC 28-8 pharmDx for non-squamous NSCLC

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
  • Primary antibody: rabbit monoclonal, clone 28-8
  • Detects PD-L1 on the plasma membranes of tumor cells, the staining of which can be completely abolished by PD-L1 gene knock-out
  • Detection in normal tissues is restricted to immune cells and infrequently the cells of epithelial origin
  • Clone 28-8 exhibits no cross reactivity to PD-L2
  • 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
  • In BMS clinical study CA209057 of patients with non-squamous NSCLC, approximately 54% and 40% had PD-L1 expression levels ≥1% and ≥5%, respectively
  • Repeatability testing of inter-instrument, inter-operator, inter-day, inter-lot and intra-run performance
  • 99% overall agreement for 1%, 5% and 10% expression levels
  • 95% confidence intervals ranged from 82.4 to 100% for NPA, PPA, and OA*
  • Reproducibility testing of day-to-day, site-to-site and observer-to-observer performance in a blinded study in three certified clinical labs
  • ≥ 94% overall agreement for ≥ 1% and ≥ 5% expression levels
  • 95% confidence intervals ranged from 78.5 to 100% for NPA, PPA, and OA

* 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





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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®.