Agilent Companion Diagnostic Assay PD-L1 IHC 28-8 pharmDx Receives European IVDR Certification

SANTA CLARA, Calif., December 10, 2024

Agilent Technologies Inc. (NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for PD-L1 IHC 28-8 pharmDx (Code SK005). This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR) 1. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. Read more