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VENTANA® PD-L1 (SP263) Assay
CE-IVD
IVD
For in vitro diagnostic use.
Driving diagnostic certainty for life-changing decisions in pathology
The VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying patients with:1
Non-small cell lung cancer (NSCLC), eligible for treatment with IMFINZI® (durvalumab), KEYTRUDA® (pembrolizumab), LIBTAYO® (cemiplimab), TECENTRIQ® (atezolizumab)
Non-squamous NSCLC, eligible for treatment with TEVIMBRA® (tislelizumab)
Non-squamous NSCLC, most likely to benefit from OPDIVO® (nivolumab)
Gastric or gastroesophageal junction (GEJ) adenocarcinoma, eligible for treatment with TEVIMBRA (tislelizumab)
About non-small cell lung cancer
Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases.2 In more than half of newly diagnosed patients, the disease has already metastasized, severely impacting long-term prognosis. While historical five-year relative survival rates for distant disease hovered below 5%, the widespread integration of precision targeted therapies and immunotherapies has nearly doubled that benchmark, though advanced NSCLC remains a critical area of unmet medical need.3,4
About gastric cancer
Gastric cancer poses a serious public health concern. In 2020, a total of 136,038 incident cases and 96,997 deaths were estimated in Europe. Although incidence rates of gastric cancer have been decreasing across the continent for decades, due to an aging population, the number of cases is expected to rise in the upcoming years, with an estimated 25% increase by 2040.5
Training and educational resources for pathologists
Explore educational content on biomarkers and disease areas, interactive interpretation training, scoring guidance and case reviews—designed to advance your knowledge and support greater proficiency with VENTANA companion diagnostic assays.
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Overview
Technical documents
Access important product documentation including relevant certificates and other resources.
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*Please refer to the approved Interpretation Guide for scoring algorithms and associated therapies in your country.
References
VENTANA PD-L1 (SP263) Assay Package Insert. REV F, 2026.
National Cancer Institute. SEER Cancer Stat Facts: Lung and Bronchus Cancer [Internet; cited 2026 Jun 18]. Available from: https://seer.cancer.gov/statfacts/html/lungb.html
American Cancer Society. Cancer Facts & Figures 2025 [Internet; cited 2026 Jun 18]. Available from: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf
World Health Organization. International Agency for Research on Cancer. GLOBOCAN 2024: Lung Cancer Global Fact Sheet. [Internet; cited 2026 Jun 18]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf
Giusti F, et al. Geographical and temporal differences in gastric and oesophageal cancer registration by subsite and morphology in Europe. [Internet; cited 2026 July 6]. Available from: https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1250107/full
F. Hoffmann-La Roche Ltd. IHC Menu Comparison. Data on file. 2025.