FDA approves PD-L1 IHC 22C3 pharmDx assay, a Keytruda companion diagnostic, for non-small cell lung cancer patients- Dako

The FDA has approved a companion diagnostic, the PD-L1 IHC 22C3 pharmDx assay, from Dako, an Agilent Technologies company, to assess the eligibility of non-small cell lung cancer patients for treatment with Keytruda (pembrolizumab), from Merck Inc. Dako hopes to gain regulatory approval for the new diagnostic in Canada, Europe and other jurisdictions next year. LabCorp is one of the first laboratory providers of the PD-L1 IHC 22C3 pharmDx test.