PD-L1 IHC 22C3 pharmDx regulatory update

FDA approved a PMA from Agilent’s Dako subsidiary for PD-L1 IHC 22C3 pharmDx as a companion diagnostic for Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK, Kenilworth, N.J.) to treat metastatic non-small cell lung cancer (NSCLC). The immunohistochemical assay uses monoclonal mouse anti-PD-L1, clone 22C3 to detect PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) NSCLC tissue. ...