Roche’s VENTANA PD-L1 (SP263) Assay receives CE IVD approval to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo

  • The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer may be eligible for treatment with Libtayo monotherapy1 based on the results of the Phase III EMPOWER-Lung 1 study.
  • This additional approval will allow more patients with locally advanced and metastatic non-small cell lung cancer broader access to the immunotherapy Libtayo.
  • PD-L1 testing provides clinicians with essential information that helps guide clinical decision making and improve patient outcomes.


Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the VENTANA PD-L1 (SP263) Assay is available in countries accepting the CE mark as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients eligible for treatment with Libtayo® (cemiplimab), a PD-1 inhibitor therapy developed by Regeneron.

More than 60 percent of patients diagnosed with non-small cell lung cancer are diagnosed at locally advanced or metastatic stage (Stage III-IV).2 With the launch of the VENTANA PD-L1 (SP263) Assay, more patients may have access to an additional immunotherapy option with Libtayo, potentially improving their treatment pathway and outcomes.

“With our companion diagnostics, we can help ensure each patient gets the most appropriate targeted treatment. This approval gives eligible advanced lung cancer patients access to the immunotherapy Libtayo as a first-line treatment,” said Jill German, Head of Pathology Lab at Roche Diagnostics. “Our high medical value PD-L1 assay portfolio is continuing to help improve access to personalised medicine.”

The VENTANA PD-L1 (SP263) Assay is the only CE IVD product available with NSCLC indications for four different immunotherapy drugs, offering oncologists a broad range of treatment options for patients. Treating non-small cell lung cancer as early as possible may improve patient outcomes.

Lung cancer is the leading cause of cancer death worldwide. Every year, more than 2.2 million people are diagnosed with lung cancer globally and up to 85 percent of these cases are non-small cell lung cancer.3,4

More information about the VENTANA PD-L1 (SP263) Assay as a companion diagnostic will be presented at the European Society for Medical Oncology on 10 September 2022 in a session titled ”Clinical interchangeability of PD-L1 IHC assays for the treatment of first-line NSCLC with cemiplimab”.

About the VENTANA PD-L1 (SP263) Assay

Roche has developed a leading, comprehensive and differentiated lung cancer immunohistochemical portfolio, with biomarkers that support multiple guidelines for the diagnosis and stratification of lung cancers. VENTANA PD-L1 (SP263) Assay is used to detect programmed death ligand-1 (PD-L1) protein in non-small cell lung carcinoma patients. PD-L1 expression on tumor cells and immune cells has been shown in clinical studies to help predict the likelihood a patient may benefit from PD-L1/PD-1 immunotherapy drugs.5 VENTANA PD-L1 (SP263) Assay testing is performed on a BenchMark ULTRA instrument and is visualised using the OptiView DAB IHC Detection Kit. Last month, Roche announced that the VENTANA PD-L1 (SP263) Assay received CE label expansion in non-small cell lung cancer as a companion diagnostic for Tecentriq® (atezolizumab).

About Roche

Founded in1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. 

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. 

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Ventana PD-L1

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.

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  1. Regeneron news release. LIBTAYO® (Cemiplimab) approved by the European Commission for first-line treatment of patients with advanced Non-small cell lung cancer with ≥50% PD-L1 expression with no EGFR, ALK, or ROS mutations  using a validated assay.  (Refer to product information for full intended use.). 
  2. EpiCast Report: NSCLC Epidemiology Forecast to 2025. GlobalData. 2016
  3. World Health Organization: GLOBOCAN 2020 – Lung Cancer: Estimated cancer incidence, mortality and prevalence worldwide. [Internet; cited May 2021] Available from:
  4. What is non-small-cell lung cancer? [Internet; cited May 2021] Available from:
  5. VENTANA PD-L1 (SP263) Assay. CE marked Package Insert. Roche Diagnostics; 2022