Roche has received a CE IVD mark for its Ventana PD-L1 (SP263) Assay as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) eligible for treatment with Regeneron’s PD-1 inhibitor therapy, Libtayo (cemiplimab).
To be available in countries accepting the CE mark, the VENTANA PD-L1 (SP263) assay detects the programmed death ligand-1 (PD-L1) protein in NSCLC patients.
It helps to identify NSCLC patients who may be eligible for treatment with Libtayo monotherapy based on the Phase III EMPOWER-Lung 1 study results.
In clinical studies, PD-L1 expression on tumour and immune cells was shown to help predict if patients were likely to benefit from PD-L1/PD-1 immunotherapy drugs.
The company stated that testing for the PD-L1 protein provides important information that supports clinical decisions and improves patient outcomes.
The test runs on the BenchMark ULTRA instrument and displays 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 company, more than 2.2 million people, of which 85% are NSCLC, are diagnosed with lung cancer every year worldwide.
Last month, the VENTANA PD-L1 (SP263) assay received CE label expansion as a companion diagnostic for identifying NSCLC patients who are eligible for treatment with Tecentriq (atezolizumab).
It is claimed to be the only CE IVD product that is available with NSCLC indications for four immunotherapy drugs.
This offers oncologists a wide range of treatment options for patients.
Recently, Roche launched the Digital LightCycler System, a new digital polymerase chain reaction (PCR) system.