www.fdanews.com/articles/193573-agilents-pd-l1-diagnostic-gains-expanded-use-in-europe-for-hnscc
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Agilent’s PD-L1 Diagnostic Gains Expanded Use in Europe for HNSCC
November 25, 2019
Agilent Technologies’ PD-L1 IHC 22C3 pharmDx assay has received the CE Mark for use in identifying head and neck squamous cell carcinoma (HNSCC) patients for treatment with Merck’s Keytruda (pembrolizumab).
The expanded indication “will give physicians in Europe critical information to inform first-line treatment decisions for patients with metastatic or unresectable recurrent HNSCC and provide the diagnostic confidence of a clinically relevant test,” said Sam Raha, president of Agilent’s diagnostics and genomics group.
Agilent noted that its diagnostic is the only trial-proven, CE Marked product for recognizing HNSCC patients for the medicine.