Device Dossier

VENTANA PD-L1 (SP263) Assay - Immunohistology cell marker IVDs

Device Dossier for VENTANA PD-L1 (SP263) Assay - Immunohistology cell marker IVDs (CT1056 - Immunohistology cell marker IVDs, Class 3, sponsor Roche…

Intended purpose

Intended for the qualitative detection of the programmed death ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC including non-squamous NSCLC tissues as an aid in identifying patients for treatment with therapies listed in the instructions for use

Functional description

Immunohistochemical staining of tissues for PD-L1 protein as an aid in identifying patients eligible for treatment with nominated therapies in selected indications

TGA Public Summary