Dako: FDA Approval Of New Companion Diagnostic For Lung Cancer

(RTTNews) - Dako, a part of Agilent Technologies (A) and a provider of cancer diagnostics, on Friday announced the U.S. Food and Drug Administration approval of a new companion diagnostic assay, PD-L1 IHC 22C3 pharmDx, that can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to a new form of treatment.

The approval of PD-L1 IHC 22C3 pharmDx strengthens Dako's portfolio of companion diagnostics and the company's leadership position in developing and commercializing companion diagnostic products.

Dako hopes to gain regulatory approval for PD-L1 IHC 22C3 pharmDx in Canada, Europe and other jurisdictions next year.

Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck & Co Inc (MRK), maker of the anti-PD-1 therapy KEYTRUDA (pembrolizumab). KEYTRUDA is approved by the FDA to treat patients with metastatic NSCLC whose tumors express PD-L1 as determined by the companion diagnostic assay and who have disease progression on or after platinum-containing chemotherapy.