10 reasons the PD-L1 (SP-263) biomarker is transforming tumour testing

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.

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

• Non-small cell lung carcinoma (NSCLC): TECENTRIQ® (atezolizumab) and LIBTAYO® (cemiplimab)

CE marked:²

• NSCLC: IMFINZI® (durvalumab), KEYTRUDA® (pembrolizumab), TECENTRIQ® (atezolizumab) and LIBTAYO® (cemiplimab)

• Non-squamous NSCLC: TEVIMBRA® (tislelizumab)

• Gastric or gastroesophageal junction (GEJ) adenocarcinoma: TEVIMBRA® (tislelizumab)

• Non-squamous NSCLC: OPDIVO® (nivolumab) ^† 

NMPA (National Medical Products Administration) approval:³

• Urothelial carcinoma (UC):  TEVIMBRA® (tislelizumab)
• NSCLC: TECENTRIQ® (atezolizumab)

Rest of world:⁴

• NSCLC*: IMFINZI® (durvalumab), KEYTRUDA® (pembrolizumab) TECENTRIQ® (atezolizumab), LIBTAYO® (cemiplimab), and TEVIMBRA® (tislelizumab)
• Non-squamous NSCLC: OPDIVO® (nivolumab)
• Esophageal squamous cell carcinoma (ESCC): TEVIMBRA® (tislelizumab)
• Gastric or GEJ adenocarcinoma: TEVIMBRA® (tislelizumab)

Analytical performance validated across 15 solid tumor types and 31 cut-offs.⁵

PD-L1 expression by immunohistochemistry (IHC) has been assessed in all clinical trials evaluating efficacy of anti-PD-1 and anti-PD-L1 agents.⁶ The validation of assay performance helps to ensure treatment decisions can be made more confidently.⁷

Currently, we have seen consistent performance in a variety of cancer types.⁸

• Urothelial carcinoma (UC)
• Non-small cell lung carcinoma (NSCLC)
• Head & neck squamous cell carcinoma (HNSCC)⁴
• Renal cell carcinoma (RCC)
• Melanoma
• Gastric or gastroesophageal junction (GEJ) adenocarcinoma
• Hepatocellular carcinoma (HCC)
• Cervical cancer
• Ovarian cancer
• Esophageal squamous cell carcinoma (ESCC)

Comprehensive scoring algorithms, training, and education activities developed with 15+ Roche pathologists.⁹

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

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 IHC⁶
• Strong agreement in PD-L1 staining of tumor cells within and between tumor blocks across multiple cutoffs in NSCLC diagnosis⁷
• Pathologist-trained algorithms support confident decision-making

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.¹⁰

• Approximately 1 in 4 patients could receive incorrect treatment based on LDT results¹¹
• IVD testing has minimal impact to overall diagnostic cost, yet could lead to a 19% increase in successful diagnosis and treatment¹¹

Early scientific evidence of future utility based on publications from various multiplex IHC studies.¹²

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 tomorrow¹²
• Combination testing with the VENTANA PD-L1 (SP263) Assay plus the CONFIRM anti-CD8 (SP57) RUO panel

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 pipetting¹²
• Fewer touch-points reduce the potential for human error while increasing safety, due to limited exposure to chemicals

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

The VENTANA PD-L1 (SP263) Assay received approval in various tumor types.¹²

• Strong EQA data demonstrates consistently high quality results¹³

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

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

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.