Roche has secured CE IVD approval for its VENTANA PD-L1 (SP263) Assay as a companion diagnostic to find patients with locally advanced and metastatic non-small cell lung cancer (NSCLC).
The VENTANA PD-L1 (SP263) Assay assists in selecting non-small cell lung cancer patients who can be suitable for treatment with Libtayo (cemiplimab) monotherapy, a PD-1 inhibitor therapy developed by Regeneron.
Available in countries accepting the CE mark, the PD-L1 Assay offers all the essential information to guide clinical decision-making and improve overall patient outcomes.
Using data from the Phase III EMPOWER-Lung 1 trial, patients with non-small cell lung cancer can use the test to find the presence of a programmed death ligand-1 (PD-L1) protein.
VENTANA PD-L1 Assay testing is carried out on a BenchMark ULTRA instrument and is displayed using the OptiView DAB IHC Detection Kit.
Roche Diagnostics Pathology Lab head Jill German said: “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.
“Our high medical value PD-L1 assay portfolio is continuing to help improve access to personalised medicine.”
According to the firm, the treatment of non-small cell lung cancer as early as possible has the potential to improve patient outcomes.
The VENTANA PD-L1 Assay gives oncologists a wide choice of therapeutic options for their patients as the only CE IVD product with NSCLC indications for four distinct immunotherapy medicines.
The likelihood that a patient will benefit from PD-L1/PD-1 immunotherapy drugs has been demonstrated in clinical studies using the expression of PD-L1 on immune and tumour cells.
Roche revealed this month that the VENTANA PD-L1 (SP263) Assay has gained CE label expansion in non-small cell lung cancer (atezolizumab) as a companion diagnostic for Tecentriq (atezolizumab).
The test is a part of a comprehensive and differentiating lung cancer immunohistochemistry portfolio with biomarkers that support multiple guidelines for the diagnosis and stratification of lung cancers.
