Agilent Receives FDA Approval for PD-L1 Companion Diagnostic on Dako Omnis
Agilent Technologies, Inc. (A)
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Source: Business Wire
SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify patients with non-small cell lung cancer who are appropriate for first-line monotherapy with KEYTRUDA (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.The FDA approval of this CDx demonstrates that Agilent is continuing to enable metastatic NSCLC patients, who previously had few and inefficient therapy options, to gain access to first-line treatment monotherapy with the targeted immunotherapy, KEYTRUDA, providing new hope for patients and their families.“We are delighted to add the first FDA approval of this important companion diagnostic on Dako Omnis,” said Simon Øs
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