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# FDA Approves Roche Assay for New Lung Cancer Therapy
- URL: https://www.fdaweb.com/fda-approves-roche-assay-for-new-lung-cancer-therapy/
- Published: 2016-10-27T12:00:00.000Z
- Updated: 2026-09-14T21:43:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137191

FDA has approved a Roche PMA for the Ventana PD-L1 (SP142) Assay as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the company’s recently approved ([see story](https://www.fdaweb.com/fda-approves-genentechs-tecentriq-for-lung-cancer/)) immunotherapy Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer. The assay is also indicated to identify patients with urothelial cancer who may benefit from the therapy.

Roche says this is the first assay to evaluate patient PD-L1 expression using both tumor cell and immune cell staining. “Determining a patient's PD-L1 expression level can provide insight into the survival benefit that may be achieved from treatment with Tecentriq,” it says.