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Agilent Technologies Gets CE-IVD Mark for Expanded Use of PD-L1 CDx in Esophageal Cancer

NEW YORK — Agilent Technologies said on Monday that it has received CE-IVD marking for the expanded use of PD-L1 IHC 22C3 pharmDx companion diagnostic assay in patients with esophageal cancer.

According to Santa Clara, California-based Agilent, the test can now be used as an aid in identifying esophageal cancer patients for treatment with the anti-PD-1 cancer drug pembrolizumab (Merck's Keytruda) using a combined positive score of at least 10.

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.

Last month, Agilent received CE marking for the test as a companion diagnostic for cemiplimab (Regeneron Pharmaceuticals and Sanofi's Libtayo) in patients with non-small cell lung cancer.