Article

10 reasons the PD-L1 biomarker is transforming tumour testing

Roche Diagnostics
Published on March 5, 2023 | 6 min read
HCP showing results to man

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:1

CE marked:2

NMPA (National Medical Products Administration) approval:3

Rest of world:4

2. Widely validated

Analytical performance validated across 15 solid tumor types and 31 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.5 The validation of assay performance helps to ensure treatment decisions can be made more confidently.6

Currently, we have seen consistent performance in a variety of cancer types.7

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 guides provide detailed scoring algorithm descriptions and guidance with images to ensure accuracy of results

4. Digital algorithm assisted

The commercially available uPath PD-L1 (SP263) image analysis, NSCLC 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 IHC5
  • Strong agreement in PD-L1 staining of tumor cells within and between tumor blocks across multiple cutoffs in NSCLC diagnosis6
  • Pathologist-trained algorithms support confident decision-making
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Digital pathology solutions

Roche Digital Pathology solutions revolutionize patient-centered care and pathology workflow efficiency with scanners and clinical decision support solutions

uPath PD-L1 (SP263) image analysis, NSCLC

5. Higher effectiveness than lab developed tests (LDTs)

In vitro diagnostic (IVD) assays are substantially more effective for aligning PD-L1-positive NSCLC patients with immunotherapy, leading to improved outcomes and a reduction in overall healthcare costs associated with disease progression, management of adverse events and end of life care.8

  • Approximately 1 in 4 patients could receive incorrect treatment based on LDT results
  • IVD testing has minimal impact to overall diagnostic cost, yet could lead to a 19% increase in successful diagnosis and treatment

6. Strategically positioned for the future

Early scientific evidence of future utility based on publications from various multiplex IHC studies.9

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 pipetting10
  • Fewer touch-points reduce the potential for human error while increasing safety, due to limited exposure to chemicals

8. Globally proven

Demonstrated quality and performance in several global external quality assessment (EQA) schemes.

The VENTANA PD-L1 (SP263) Assay received approval in various tumor types.10

  • Strong EQA data demonstrates consistently high quality results

*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.11

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 approved for multiple PD-L1 therapies, opening the door for multiple personalized treatments in I/O across several indications

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

The right test, from the right partner, for the right treatment

Provide critical, actionable information to inform therapeutic decisions.

The VENTANA PD-L1 (SP263) Assay is transforming tumor testing. In choosing the right diagnostic test and partner, you are establishing long-term sustainability, bringing more personalized healthcare to your patients and their loved ones.

VENTANA PD-L1 (SP263) Assay, non-small cell lung cancer (NSCLC), urothelial carcinoma, bladder cancer

VENTANA® PD-L1 (SP263) Assay

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), urothelial carcinoma (UC) and other tumor tissues stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument.
PD-L1 SP263 Assay UC stain image

VENTANA® PD-L1 (SP263) Assay

VENTANA PD-L1 (SP263) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP263 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue stained with OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument.

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Contributors

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Roche Diagnostics

Roche Diagnostics is a division of Roche, developing and integrating diagnostic solutions that address today’s healthcare challenges while anticipating tomorrow’s needs. In more than 100 countries, we provide one of the industry’s most comprehensive in vitro diagnostics portfolios spanning molecular diagnostics, clinical chemistry and immunoassays, tissue diagnostics, Point of Care testing, patient self-testing, next-generation sequencing, laboratory automation and IT, as well as digital health and decision-support solutions.

Our articles are authored by Roche Diagnostics subject matter experts, drawing on collective expertise across multiple disciplines to provide reliable insights for healthcare professionals worldwide.

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Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

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*Approval vary per country

References

  1. VENTANA PD-L1 (SP263) Assay Package Insert, US, 2023.
  2. VENTANA PD-L1 (SP263) Assay Package Insert, CE IVD, 2024.
  3. VENTANA PD-L1 (SP263) Assay Package Insert, China, 2023.
  4. VENTANA PD-L1 (SP263) Assay Package Insert, ROW, 2022.
  5. 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
  6. 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
  7. 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.
  8. 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
  9. Hurwitz, J.T., Vaffis, S., Grizzle, A.J. et al. Cost-Effectiveness of PD-L1 Testing in Non-Small Cell Lung Cancer (NSCLC) Using In Vitro Diagnostic (IVD) Versus Laboratory-Developed Test (LDT). Oncol Ther (2022). https:///10.1007/s40487-022-00197-1
  10. 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.
  11. PD-L1 EQA Data. https://www.nordiqc.org/epitope.php?id=107. Accessed January 2024.