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|
*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.
|PD-L1 IHC 28-8 pharmDx||SK005|
Required but not included in kit:
EnVision FLEX Wash Buffer, 20x
EnVision FLEX Hematoxylin (Link)
Contact your local sales representative
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®.
Welcome To Agilent Technologies
To enhance your online experience and our partnership with you, please select your country from the lists below.This will ensure that you discover the most relevant information and services available, including local product news, events, and more.