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Agilent Technologies Inc. today announced the issuing of a companion diagnostic Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006. This CDx assay has previously been CE-IVD–marked...
The clearance applies to use of the companion diagnostic to identify patients with multiple cancer types for treatment with Merck's Keytruda and Regeneron's Libtayo.
Agilent Technologies Inc. (NYSE: A) today announced that previously CE-IVD marked instruments, kits, and reagents were released as IVDR Class A on May 26, 2022, in compliance with the new EU IVDR regulation. This