NEW YORK (GenomeWeb) – Dako, an Agilent subsidiary, has declared CE Mark self-certification for its PD-L1 IHC 22C3 pharmDx, a companion diagnostic to identify best responders to Merck's anti-PD-1 immunotherapy Keytruda (pembrolizumab).
Dako developed the PD-L1 IHC 22C3 pharmDx test in partnership with Merck. By affixing a CE Marking on a product, the manufacturer is declaring that it is in conformity with EU legislation and requirements and can now be sold throughout the European Economic Area.
In June, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a recommendation for Keytruda as a treatment for previously treated, advanced non-small cell lung cancer in patients with PD-L1 expressing tumors.
The FDA last October approved the PD-L1 IHC 22C3 pharmDx tests alongside Keytruda in NSCLC.
"Because individuals often respond differently to the same treatment, scientists have been putting more emphasis on personalized medicine, which is where PD-L1 IHC 22C3 pharmDx comes into play," Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group, said in a statement.