10 reasons the PD-L1 biomarker is transforming tumour testing

Better together—companion diagnostics are changing cancer care

Striving for certainty when delivering a diagnosis.

When looking for ways to make more informed, data-driven decisions, companion diagnostics present a promising way forward for personalized healthcare. Using well-designed assays that run on easy-to-use automated systems, you can reduce errors caused by manual handling and streamline overall workflows while decreasing the number of tests needed to identify patients appropriate for various treatment options.

The VENTANA PD-L1 (SP263) Assay is tested on patient samples against a growing range of tumor types to determine who may be most likely to respond to specific therapies.

These are the top 10 reasons the expanding application of this assay is ideal for future-focused labs looking for a sustainable PD-L1 diagnostic solution.

1. Highly collaborative


The VENTANA PD-L1 (SP263) Assay is under evaluation in 40+ clinical studies in collaboration with more than 10 pharma partners.

We set our focus on the future by combining the power of expertise, expanding collaborations to personalize care and create the best possible outcomes for patients.

FDA approved:

CE marked:

NMPA (National Medical Products Administration) approval:

  • UC: Tislelizumab (BGB-A317)

Rest of world:




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2. Widely validated


Analytical performance validated across 10 solid tumor tissue types and 16 cut-offs.

PD-L1 expression by immunohistochemistry (IHC) has been assessed in all clinical trials evaluating efficacy of anti-PD-1 and anti-PD-L1 agents.1 The validation of assay performance helps to ensure treatment decisions can be made more confidently.2

Currently, we have seen consistent performance in a variety of cancer types.3

  • Ovarian cancer 
  • Esophageal squamous cell carcinoma (ESCC)

3. Robustly developed


Comprehensive scoring algorithms, training, and education activities developed with 15+ Roche pathologists.

Cancer care is complex. The VENTANA PD-L1 (SP263) Assay is one part of Roche’s oncology offering:

  • Global network of experts to assist in training and implementation

  • Interpretation guide provides detailed scoring algorithm descriptions and guidance with images to ensure accuracy of results

Comprehensive scoring algorithms for PD-L1 testing animation
The VENTANA PD-L1 (SP263) Assay is digital algorithm assisted

4. Digital algorithm assisted


Commercially available CE-marked digital pathology scoring algorithm in NSCLC.

The VENTANA PD-L1 (SP263) Assay algorithm has been thoroughly validated and CE marked for use in NSCLC.

  • Ready-to-use and highly standardized, showing improvement in the quality of predictive IHC1

  • Strong agreement in PD-L1 staining of tumor cells within and between tumor blocks across multiple cutoffs in NSCLC diagnosis2

  • Pathologist-trained algorithms support confident decision-making

5. First for FNA


First CE marked PD-L1 test analytically validated for formalin-fixed paraffin-embedded (FFPE) fine needle aspiration (FNA) cytology specimens in NSCLC.

  • Previously, PD-L1 testing was not analytically validated for cytology specimens, while in some countries, more than 50% of patients with NSCLC possess only cytological samples available for diagnosis5

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6. Strategically positioned for the future


Early scientific evidence of future utility based on publications from various multiplex IHC studies.6


Expanding application of the VENTANA PD-L1 (SP263) Assay allows laboratories to position themselves for future success.

  • Strong evidence for future use provides reliability today and sustainability tomorrow

  • Combination testing with the VENTANA PD-L1 (SP263) Assay plus the CONFIRM anti-CD8 (SP57) RUO panel

7. Fully automated


Automated workflow requires minimal hands-on time for high-quality staining.

Automation increases efficiency and productivity, allowing laboratory staff to focus on other value-added tasks.

  • Ready-to-use, ensuring accurate, repeatable results with no calculations, dilutions, or pipetting7

  • Fewer touch-points reduce the potential for human error while increasing safety, due to limited exposure to chemicals

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8. Globally proven


Demonstrated quality and performance in several global EQA schemes.

The VENTANA PD-L1 (SP263) Assay received approval in various tumor types.7

  • Strong EQA data demonstrates consistently high result quality*

*Assessments developed under the guidance of EQA groups. When used according to manufacturer recommendations, the VENTANA PD-L1 (SP263) Assay attained the highest pass rate among evaluated solutions.8

9. Gateway to immuno-oncology


Access to key immuno-oncology (I/O) market.

The I/O space has many prescribing requirements and restrictions.

  • VENTANA PD-L1 (SP263) Assay is the only solution linked to various approved PD-L1 therapies, opening the door for multiple personalized treatments in I/O across several indications
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10. Broadly available


Registered and commercialized in approximately 60 countries.

The VENTANA PD-L1 (SP263) Assay runs on the largest installed base in the world—the BenchMark series IHC/ISH instruments.

  • Partnership with Roche connects you with an established global network with expert local support capabilities, enabling you to deliver every result with confidence

Talk to your Roche representative for more information.
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  1. Adam J, Le Stang N, Rouquette I, et al. Multicenter harmonization study for PD-L1 IHC testing in non-small-cell lung cancer. Ann Oncol. 2018;29(4):953-958. doi:10.1093/annonc/mdy014

  2. Williams GH, Nicholson AG, Snead DRJ, et al. Interobserver Reliability of Programmed Cell Death Ligand-1 Scoring Using the VENTANA PD-L1 (SP263) Assay in NSCLC. J Thorac Oncol. 2020;15(4):550-555. doi:10.1016/j.jtho.2019.11.010

  3. Nielsen A, Manriquez LH, Hayden D, et al. Precision and Repeatability of the VENTANA PD-L1 (SP263) Assay Across Six Different Tumor Types. Poster presented at: USCAP 2020; March 2, 2020; Los Angeles, CA.

  4. Rebelatto MC, Midha A, Mistry A, et al. Development of a programmed cell death ligand-1 immunohistochemical assay validated for analysis of non-small cell lung cancer and head and neck squamous cell carcinoma. Diagn Pathol. 2016;11(1):95. Published 2016 Oct 8. doi:10.1186/s13000-016-0545-8

  5. Takigawa N, Ochi N, Yamane H. Histology versus cytology: PD-L1 testing in non-small cell lung cancer. Transl Lung Cancer Res. 2018;7(Suppl 3):S225-S227. doi:10.21037/tlcr.2018.08.08

  6. Zhang W, Khojasteh M, Hubbard A, et al.n 117PCharacterization of PD-L1, CD8, CD3, CD68 and PanCK in tumor microenvironment of Gl tract tumors with respect to patients’ mismatch repair status and anti-PD-1 treatment outcome using 5Plex IHC and whole slide image analysis. Ann Oncol. 2018;29(suppl 8):viii36-37.

  7. VENTANA PD-L1 (SP263) Assay Instructions for Use. Tuscon, AZ: Ventana Medical Systems, Inc. 2020.

  8. PD-L1 EQA Data. Accessed September 09, 2020.