Agilent Gets FDA Approval For PD-L1 Companion Diagnostic On Dako Omnis

(RTTNews) - Agilent Technologies Inc. (A) said that the U.S. Food and Drug Administration has approved the company's PD-L1 IHC 22C3 pharmDx as a companion diagnostic or CDx to identify patients with non-small cell lung cancer who are appropriate for first-line monotherapy with KEYTRUDA or pembrolizumab on the Dako Omnis platform.

Dako Omnis is Agilent's fully automated, walk-away solution for staining tumor samples that provides a flexible, high-throughput diagnostic service integrated into the core of the laboratory workflow.

Lung cancer is the leading cause of cancer-related mortality in the United States, with an estimated incidence of 142,000 deaths in 2019 alone.