www.fdanews.com/articles/203650-agilents-lung-cancer-assay-wins-expanded-ce-mark
Agilent’s Lung Cancer Assay Wins Expanded CE Mark
July 22, 2021
Santa Clara, Calif.-based Agilent Technologies has received the CE mark for expanded use of its PD-L1 IHC (immunohistochemistry) 22C3 pharmDx assay for patients with nonsmall-cell lung cancer (NSCLC).
The expanded certification covers use of the assay as an aid in identifying patients with PD-L1 expression in their tumors who can be treated with Regeneron’s antibody Libtayo (cemiplimab).
The assay’s companion diagnostic can help guide treatment decisions for NSCLC, the Santa Clara, Calif.-based company said.