FDA Approves Roche’s PD-L1 Biomarker Assay

The FDA has approved Roche’s Ventana PD-L1 assay, a complementary diagnostic tool for assessing PD-L1 status in patients suffering from metastatic urothelial cancer who are considering treatment with Roche’s Tecentriq.

The assay determines PD-L1 status through immune cell staining to help aid immunotherapy decisions.

The in vitro test uses immunohistochemistry technology to “visually enhance and score [the] PD-L1 protein on tumor-infiltrating immune cells,” according to the company. — Anisa Jibrell