Agilent Company Dako, Announces FDA Approval of New Companion Diagnostic for Lung Cancer

Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, announced Oct. 2 that the U.S. Food and Drug Administration (FDA) approval of a new companion diagnostic assay that can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to a new form of treatment. The approval of PD-L1 IHC 22C3 pharmDx strengthens Dako's portfolio of companion diagnostics and the company's leadership position in developing and commercializing companion diagnostic products. Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck & Co., Inc. (known as MSD outside the U.S. and Canada), maker of the anti-PD-1 therapy KEYTRUDA® (pembrolizumab).  KEYTRUDA is approved by the FDA to treat patients with metastatic NSCLC whose tumors express PD-L1 as determined by the companion diagnostic assay and who have disease progression on or after platinum-containing chemotherapy. KEYTRUDA is an immunotherapy that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby helping the immune system do what it is meant to do: help detect and fight cancer cells. KEYTRUDA can also cause the immune system to