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Agilent Keytruda CDx Gets CE IVD Mark in Europe

NEW YORK – Agilent Technologies said today that it has received CE-IVD marking in Europe for its PD-L1 IHC 22C3 assay for head and neck squamous cell carcinoma (HNSCC), a companion diagnostic in combination with Merck's anti-PD-1 immunotherapy pembrolizumab (Keytruda). 

"PD-L1 is an essential biomarker for anti-PD-1 therapies like Keytruda," Sam Raha, president of Agilent's Diagnostics and Genomics Group, said in a statement. "The expanded indication of PDL-L1 IHC 22C3 pharmDx will give physicians in Europe critical information to inform fist-line treatment decisions for patients with metastatic or unresectable recurrent HNSCC and provide the diagnostic confidence of a clinically relevant test." 

In collaboration with Merck, Agilent subsidiary Dako originally developed the PD-L1 IHC 22C3 pharmDx assay to help clinicians identify non-small cell lung cancer and urothelial carcinoma patients and treat them with Keytruda. 

In June, the US Food and Drug Administration expanded its approval of the assay as a CDx for Keytruda for HNSCC, followed by a later expansion of an approval for Keytruda for esophageal squamous cell carcinoma in August.