Roche’s VENTANA PD-L1 (SP263) Test Obtains CE Mark Extension as a Companion Diagnostic to Identify Non-Small Cell Lung Cancer Patients Eligible for Tecentriq

  • The VENTANA PD-L1 (SP263) test helps determine which patients with non-small cell lung cancer may benefit from treatment with Tecentriq immunotherapy based on results from the Phase III IMpower010 study.1
  • This label expansion strengthens Roche’s industry-leading portfolio of companion diagnostics and builds on its commitment to improving personalized healthcare for better patient outcomes.

TUCSON, Ariz., August 24, 2022 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE mark extension of the VENTANA PD-L1 (SP263) test in non-small cell lung cancer (NSCLC) in as a companion diagnostic for Tecentriq® (atezolizumab). This reinforces the company’s commitment to guiding clinical decision-making through innovative, high-quality tests that improve patient access to personalized healthcare.

The current standard of care for patients with early-stage lung cancer is tumor removal, which may be followed by chemotherapy. Unfortunately, about half of these patients will see their cancer come back after surgery.2 The European Commission has approved Tecentriq in June 2022 as adjuvant therapy after surgery and platinum-based chemotherapy for adults whose NSCLC stage II-IIIA tumors have elevated PD-L1 protein expression. The VENTANA PD-L1 (SP263) test identifies NSCLC patients who may be eligible for Tecentriq monotherapy in this indication, potentially reducing their risk of disease recurrence or death by more than half.

“With the early detection of lung cancer, it is possible to give patients more treatment options and potentially improve a patient’s outcome,” said jill german, head of the pathology laboratory at Roche Diagnostics. “We are proud to offer a PD-L1 test that could qualify lung cancer patients for Tecentriq therapy. With this latest expansion, clinicians can consider multiple targeted immunotherapy options with a single test to quickly determine the right treatment for each patient.

The VENTANA PD-L1 (SP263) assay was used in the Study IMpower010 sponsored by Genentech, a member of the Roche group, to identify patients whose tumors expressed the protein PD-L1. The IMpower010 clinical study began in 2015 with the aim of understanding how patients would respond to treatment with Tecentriq after traditional surgery and chemotherapy. In 2021, Genentech reported a 57% reduction in the risk of disease recurrence or death in Tecentriq patients whose tumors express PD-L1 protein on ≥ 50% of tumor cells.

Lung cancer remains the leading cause of cancer-related death worldwide, with more than 2.2 million people diagnosed worldwide last year.3 Launch of Roche’s VENTANA PD-L1 (SP263) test as a companion diagnostic to identify patients with non-small cell lung cancer eligible for Tecentriq demonstrates the company’s commitment to improving patient access to personalized health care.

About the VENTANA PD-L1 (SP263) Assay
The VENTANA PD-L1 (SP263) test is used to detect programmed death ligand-1 (PD-L1) protein in patients with non-small cell lung carcinoma (NSCLC). PD-L1 expression on tumor cells and immune cells has been shown in clinical studies to help predict the likelihood that a patient will benefit from PD-L1/PD-1 immunotherapy drugs.4

The VENTANA PD-L1 (SP263) assay is performed on a BenchMark ULTRA instrument and is visualized using the OptiView DAB IHC detection kit.

Roche has developed a leading, comprehensive and differentiated immunohistochemical portfolio for lung cancer, with biomarkers that support multiple guidelines for the diagnosis and stratification of lung cancers.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded drugs, Roche has become the largest biotechnology company in the world and the world leader in in vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics to improve and save the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform the way 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 pharmacy with insights from clinical practice.

In recognition of our efforts to pursue a long-term perspective in everything we do, Roche has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indexes for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare with local partners in all the countries where we work.

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

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All trademarks used or mentioned in this press release are protected by law.

[1] A pivotal phase III study shows that Roche’s Tecentriq helped people with early lung cancer live longer without their disease coming back.
[2] Yano T, et al. Therapeutic strategy for postoperative recurrences in patients with non-small cell lung cancer. World J Clin Oncol. 2014;5(5):1048-1054.
[3] World Health Organization: GLOBOCAN 2020 – Lung cancer: Estimated incidence, mortality and prevalence of cancer worldwide. [Internet; cited May 2021] 1.Available at:
[4] VENTANA PD-L1 Assay (SP263). CE marked packaging insert. Roche Diagnostics; 2022

For more information, please contact:

Jo Lynn GaringRoche Diagnostics Communication
Mobile: +1 317-363-7286
E-mail: [email protected]


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