| |
| pdl1nsclcatezosp263.docx [2026/04/08 03:50] – created gilbert | pdl1nsclcatezosp263.docx [2026/04/08 03:52] (current) – gilbert |
|---|
| **D**iagnostic test: PDL1 SP263 | **D**iagnostic test: PDL1 SP263 |
| |
| **Result: Positive TPS >= 50% or Negative TPS < 50% or Inadequate** | **Result: Positive TPS >= 50% <color red> **OR** </color> Negative TPS < 50% <color red> **OR** </color> Inadequate** |
| |
| Performed on block %%**%%* | Performed on block %%**%%* |
| Batch controls: **Adequate**; On slide controls: **Adequate**; Immune cell staining: **Present**; | 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). | 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 | Test ID: PDL1NSCLCATEZOSP263 |
| |
| {{:PDL1NSCLCATEZOSP263.docx | PDL1NSCLCATEZOSP263}} | {{:PDL1NSCLCATEZOSP263.docx | PDL1NSCLCATEZOSP263}} |
