Agilent Receives European IVDR Certification for Companion Diagnostic Assay in Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Agilent Technologies, Inc. (A)
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Source: Business Wire
European certification for PD-L1 IHC 22C3 pharmDx to help gastric or GEJ adenocarcinoma patients for KEYTRUDA® therapy SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced its PD-L1 IHC 22C3 pharmDx (Code SK006) assay has received European IVDR certification for the use as a Companion Diagnostic (CDx) to aid in the identification of gastric or gastroesophageal Junction (GEJ) adenocarcinoma patients who may be eligible for treatment with KEYTRUDA® (pembrolizumab)1. PD-L1 IHC 22C3 pharmDx (Code SK006) is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. KEYTRUDA is an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada).In addition to gastric or GEJ adenocarcinoma, PD-L1 IHC 22C3 pharmDx is IVDR certified as an aid in identifying non-small cell lung cancer (NSCLC), urothelial carcinoma, esophageal cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative bre
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