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Roche Obtains CE Mark for Ventana PD-L1 Assay as CDx for Libtayo

NEW YORK – Roche said on Friday that its Ventana PD-L1 (SP263) test has received CE marking as a companion diagnostic for Regeneron's Libtayo (cemiplimab) in patients with lung cancer. 

The test is intended to determine which patients with non-small cell lung cancer (NSCLC) may be eligible for treatment with Libtayo, a PD-1 inhibitor monotherapy.

The assay detects programmed death ligand-1 protein, expression of which on tumor and immune cells has been correlated with benefit from PD-L1 or PD-1 immunotherapy drugs, Roche said in a statement. The test runs on Roche's Benchmark Ultra instrument. 

"With our companion diagnostics, we can help ensure each patient gets the most appropriate targeted treatment," Jill German, Roche Diagnostics' head of pathology lab, said in a statement. "This approval gives eligible advanced lung cancer patients access to the immunotherapy Libtayo as a first-line treatment."

Last month, the test received a CE label expansion for use in NSCLC patients to determine eligibility for Roche's immune checkpoint inhibitor Tecentriq (atezolizumab).