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Agilent Nabs FDA Approval for PD-L1 Companion Diagnostic

NEW YORK – Agilent Technologies announced Thursday its PD-L1 IHC 22C3 pharmDx received approval from the US Food and Drug Administration as a companion diagnostic for Merck's pembrolizumab (Keytruda) on the Dako Omnis platform.

The test identifies patients with non-small cell lung cancer who are appropriate for first-line monotherapy with pembrolizumab. The Dako Omnis platform provides a fully automated solution for staining tumor samples with a high-throughput diagnostic service. 

Pembrolizumab is a humanized monoclonal antibody that increases the immune system's ability to detect and fight tumor cells. It blocks the interaction between PD-1 and PD-L1 and PD-L2, activating T lymphocytes.