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Medical Devices / Submissions and Approvals

EU Expands CE Mark Indication for Agilent Technologies’ Dako Companion Diagnostics

Feb. 2, 2017

Agilent Technologies has receive an expanded CE mark for its Dako PD-L1 IHC 22C3 pharmDx which can now be used to determine PD-L1 expression status to inform the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients with Keytruda.

The intended use allows PD-L1 IHC 22C3 pharmDx to detect PD-L1 expression in both untreated and previously treated metastatic patients. — Cynthia Jessup

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