Agilent Companion Diagnostic Expands CE-IVD Mark in Europe to Include Esophageal Cancer
Excerpt from the Press Release:
Agilent Technologies Inc. (NYSE: A) today announced that the company’s PD-L1 IHC 22C3 pharmDx assay has expanded its use in Europe. The assay is now CE-IVD marked for use as an aid in identifying esophageal cancer patients for treatment with KEYTRUDA using Combined Positive Score (CPS) ≥ 10.1 In Europe, KEYTRUDA is approved in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2 negative gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10].2
“PD-L1 has been established as an essential biomarker for anti-PD-1 therapies like KEYTRUDA,” said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. “Pathologists’ confidence in their PD-L1 test is critical, as a growing number of patients are becoming eligible for treatment with these therapies. With expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent can provide pathologists with the quality, reliability, and accuracy they need to ensure diagnostic confidence.
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