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.
Demonstrated clinical results
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.
Robust performance
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 |
| Analytical Specificity |
- 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
|
| Sensitivity |
- Broad dynamic range of PD-L1 expression (0-100% tumor cells positive, 0-3 staining intensity) exhibited in study of 104 unique cases of melanoma archival FFPE specimens
- In BMS clinical study CheckMate CA209067 of patients with melanoma, approximately 58% had PD-L1 expression levels ≥1%
|
Repeatability
|
- Repeatability testing of inter-instrument, inter-operator, inter-day, inter-lot and intra-run performance
- ≥ 90% overall agreement for ≥1% expression level
- 95% confidence intervals ranged from 83.2 to 99.4% for ANA, APA, and OA*
|
| External Reproducibility |
- Reproducibility testing day-to-day, site-to-site and observer-to-observer performance in a blinded study in three certified clinical labs
- ≥ 90% overall agreement for ≥1% expression level
- 95% confidence intervals ranged from 88.1 to 100% for ANA, APA, and OA*
|
*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.
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 PT101 |
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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®.
