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Agilent companion Dx gets expanded approval

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August 2018—Agilent Technologies announced that the FDA has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use. PD-L1 IHC 22C3 pharmDx is a laboratory test doctors can use to identify the protein programmed cell death ligand 1 in tumor tissue obtained from patients with lung and gastric cancer. This supplement expands the indications for use for this test to include determining whether patients with cervical cancer are eligible for treatment with pembrolizumab (Keytruda, Merck). This follows an initial FDA approval for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer and a subsequent expanded approval to include gastric or gastroesophageal junction adenocarcinoma.

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