Roche’s Ventana PD-L1 Assay Gains CE-IVD Mark

Roche’s Ventana PD-L1 (SP263) assay received the CE-IVD mark as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients who are eligible for the PD-1 inhibitor Libtayo (cemiplimab) and other immunotherapy drugs.

The assay is used to detect PD-L1 protein in NSCLC patients, the presence of which could indicate a likelihood that the patient would benefit from immunotherapy agents.

Assay testing is performed on Roche’s BenchMark ULTRA instrument and is visualized using its OptiView DAB IHC Detection Kit, the company said.

This 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, said Roche.