PD-L1 IHC BIOMARKER

Assay Purpose:

Diagnostic : Lung Non Small Cell Carcinoma stage II to IIIA

Drug: Atezolizumab (Roche) as adjuvant therapy

Diagnostic test: PDL1 SP263

Result: Positive TPS >= 50% or Negative TPS < 50% or Inadequate

Performed on block ***

Interpretation: Tumour Percentage Score (TPS) - Negative (< 50%), Positive (>= 50%)

Batch controls: Adequate; On slide controls: Adequate; Immune cell staining: Present;

Disclaimer: Atezolizumab monotherapy adjuvant for resected stage II to stage IIIA NSCLC who received platinum-based chemotherapy and whose tumours have PD_L1 expression on ≥ 50% of tumour cells and do not have EGFR or ALK mutations. (Reference: Enriqueta Felip, et al. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage II–IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial, The Lancet, Volume 398, Issue 10308, 2021, Pages 1344-1357,ISSN 0140-6736. VENTANA PD-L1 (SP263) Assay is 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) tissue stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument.This assay is not interchangeable with other PD-L1 assays and cannot be used for other type of cancers. On slide controls include one piece of tonsil (with expected PD-L1 staining positive in immune cells and keratinocytes) and one piece of liver (with expected PD-L1 staining negative in hepatocytes).

Test ID: PDL1NSCLCATEZOSP263

PDL1NSCLCATEZOSP263