Agilent Technologies reported FDA approvals for additional PD-L1 companion diagnostic assays and raised fiscal guidance after a strong third-quarter performance. Among the regulatory items, the FDA approved Agilent’s PD-L1 IHC 22C3 pharmDx Code GE006 for automated Dako Omnis platform use, supporting patient selection for Merck’s Keytruda across specified tumor types. Agilent also received FDA clearance for PD‑L1 IHC 28‑8 pharmDx, Code SK005 as a companion diagnostic for Bristol Myers Squibb’s Opdivo or Opdivo Qvantig in indicated esophageal and gastric cancers. The updates reinforce Agilent’s position in the companion diagnostic workflow as labs increasingly standardize around specific automation platforms. For biotech partners, expanded diagnostic label coverage can reduce friction in trial enrollment and accelerate translation to clinical practice through clearer biomarker eligibility pathways.
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