Agilent Technologies received expanded FDA approval for its Keytruda CDx companion diagnostic, enabling the PD-L1 IHC 22C3 pharmDx Code GE006 assay to be used across additional cancers on the automated Dako Omnis platform. The broadened label expands where laboratories can apply the diagnostic using standardized automation. The update matters operationally for clinical labs and oncology programs because platform compatibility can reduce workflow variability and shorten time-to-result for testing that informs pembrolizumab treatment decisions. It also affects payer and coverage discussions tied to guideline-aligned use of PD-L1 testing. For developers, the decision reiterates how assay platform automation is becoming central to companion diagnostic deployment in routine oncology care.
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