European certification for PD-L1 IHC 22C3 pharmDx to help gastric or GEJ adenocarcinoma patients for KEYTRUDA® therapy
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 breast cancer (TNBC), and cervical cancer patients for treatment with KEYTRUDA. Consequently, PD-L1 IHC 22C3 pharmDx is labeled for seven cancer indications and is the only IVDR-certified CDx to identify gastric and GEJ adenocarcinoma patients for treatment with KEYTRUDA.