Roche’s Ventana PD-L1 Test Gets CE Label Expansion

Roche’s Ventana PD-L1 test has gained and expanded CE mark as a companion diagnostic to identify nonsmall-cell lung cancer (NSCLC) patients who are eligible for the company’s immunotherapy Tecentriq (atezolizumab).

The assay detects programmed death ligand-1 (PD-L1) protein in NSCLC 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.

The European Commission approved Tecentriq in June as an adjuvant treatment following surgery and platinum-based chemotherapy for adults whose Stage II-IIIA NSCLC tumors have high PD-L1 protein expression.

The expanded CE mark was supported by positive results from a phase 3 study in which the assay identified NSCLC patients who could benefit from Tecentriq.