Device Dossier
PD-L1 IHC 28-8 pharmDx
Device Dossier for PD-L1 IHC 28-8 pharmDx (CT1056 - Immunohistology cell marker IVDs, Class 3, sponsor Agilent Technologies). ARTG record, intended…
- GMDN category: CT1056 - Immunohistology cell marker IVDs
Intended purpose
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 (nsNSCLC), melanoma, and esophageal squamous cell carcinoma (ESCC) tissues. It is indicated as an aid in identifying ESCC patients with tumour cell PD-L1 expression ≥ 1% for treatment with OPDIVO® (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy or OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).
Functional description
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) cancer tissues using EnVision FLEX visualization system on Autostainer Link 48.