www.fdanews.com/articles/204114-agilent-gets-expanded-ce-mark-for-esophageal-cancer-diagnostic-for-keytruda
Agilent Gets Expanded CE Mark for Esophageal Cancer Diagnostic for Keytruda
August 25, 2021
Agilent Technologies’ pharmDx PD-L1 immunohistochemistry (IHC) assay has received an expanded CE mark for identifying esophageal cancer patients who can be treated with Merck’s monoclonal antibody Keytruda (pembrolizumab).
The Santa Clara, Calif.-based company developed the assay as a companion diagnostic for Keytruda in partnership with Merck. Keytruda, which targets the PD-LI protein, has been approved for treatment of multiple cancers.
The PD-L1 IHC pharmDx is a standardized assay with all the necessary components for 50 tests in one kit.