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Related Experiment Video

Updated: Jan 3, 2026

Using 22C3 Anti-PD-L1 Antibody Concentrate on Biopsy and Cytology Samples from Non-small Cell Lung Cancer Patients
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Interobserver Reliability of Programmed Cell Death Ligand-1 Scoring Using the VENTANA PD-L1 (SP263) Assay in NSCLC.

Gareth H Williams1, Andrew G Nicholson2, David R J Snead3

  • 1Oncologica UK Ltd., Cambridge, United Kingdom.

Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer
|November 29, 2019
PubMed
Summary

The VENTANA PD-L1 (SP263) Assay demonstrates high interobserver reliability for scoring programmed cell death ligand-1 (PD-L1) in non-small cell lung cancer (NSCLC) tumor cells. This reproducibility supports its use in selecting patients for PD-1/PD-L1 therapies.

Keywords:
Assay reliabilityImmunohistochemistryInterobserver concordanceProgrammed cell death ligand-1SP263

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Area of Science:

  • Oncology
  • Pathology
  • Immunotherapy

Background:

  • The VENTANA PD-L1 (SP263) Assay is approved for patient selection in non-small cell lung cancer (NSCLC) and urothelial carcinoma treated with anti-programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) therapies.
  • Accurate assessment of PD-L1 expression is crucial for guiding these immunotherapies.

Purpose of the Study:

  • To evaluate the interobserver reliability of the VENTANA PD-L1 (SP263) Assay for scoring PD-L1 expression in tumor cells (TCs) of NSCLC.
  • To assess the reproducibility of PD-L1 scoring using the SP263 assay among pathologists.

Main Methods:

  • Six European pulmonary pathologists independently scored PD-L1 tumor cell (TC) scores in 200 NSCLC tissue samples stained with the SP263 assay.
  • Interobserver agreement was analyzed using intraclass correlation coefficients and Fleiss' kappa.

Main Results:

  • High pair-wise correlations (R² >0.89) and an intraclass correlation coefficient of 0.96 indicated strong agreement in TC scoring.
  • Over 90% agreement was observed for TC scores of 1% and above, and over 94% for scores of 25% and 50% and above.
  • Fleiss' kappa demonstrated substantial to almost perfect agreement for various PD-L1 expression thresholds.

Conclusions:

  • The assessment of tumor cell PD-L1 score in NSCLC using the SP263 assay is highly reproducible.
  • This high reproducibility enhances confidence in the assay's accuracy for selecting patients eligible for anti-PD-1/PD-L1 therapy.