VENTANA® PD-L1 (SP263) Assay

US-FDA
IVD For in vitro diagnostic use.
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VENTANA PD-L1 SP263 Assay UC

Driving diagnostic certainty for life-changing decisions in pathology

The VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying patients with non-small cell carcinoma (NSCLC), eligible for treatment with TECENTRIQ® (atezolizumab) or LIBTAYO® (cemiplimab).1

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

Benefits at a glance

Benefits at a glance

Ready-to-use, clinically validated test designed to enable timely, reproducible results, backed by deep medical and scientific rigor, and stringent development protocols.

Empowers clinicians with critical insights needed to confidently make personalized treatment decisions that can improve patient outcomes.

Robust, crisp PD-L1 staining profile in both tumor cells (TC) and tumor-infiltrating immune cells (IC).*

Single assay test to guide immunotherapy decisions across an extensive portfolio of checkpoint inhibitors.

Focused, hands-on tools and educational resources that aid pathologists in the scoring and interpretation of VENTANA assays.

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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

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    *Please refer to the approved Interpretation Guide for scoring algorithms and associated therapies in your country.  

    References

    1. VENTANA PD-L1 (SP263) Assay Package Insert. REV C. 2024. 

    2. 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.

    3. 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.

    4. 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.