FDA approves Ventana PD-L1 (SP142) Assay as diagnostic for non-small cell lung cancer- Roche

Roche has announced approval of the Ventana PD-L1 (SP142) Assay by the U.S. FDA as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the FDA-approved Roche cancer immunotherapy Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer (NSCLC). The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer (UC) who may benefit from treatment with Tecentriq. Roche will continue to pursue regulatory approval for the Ventana PD-L1 (SP142) Assay in combination with Tecentriq in other cancer indications and in other geographies.

The Ventana PD-L1 (SP142) Assay can now be performed on the Ventana BenchMark ULTRA automated tissue staining instrument. With an established presence in laboratories globally, availability of the assay on the Ventana BenchMark ULTRA instrument can provide broader access for patients and decrease the time spent waiting for PD-L1 test results.