On June 2, 2026 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved the expanded use of PD-L1 IHC 22C3 pharmDx, Code GE006, for use on the Dako Omnis platform to aid in identifying patients in the United States with esophageal squamous cell carcinoma (ESCC)3, triple-negative breast cancer (TNBC)4, cervical cancer5, and gastric or gastroesophageal junction (GEJ) adenocarcinoma6, who may be eligible for treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.
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This approval expands access to PD-L1 testing across four additional tumor types beyond the previously approved non-small cell lung cancer (NSCLC)7 and head and neck squamous cell carcinoma (HNSCC)8. Until now, these FDA-approved PD-L1 IHC 22C3 pharmDx indications have been available on Autostainer Link 48 (ASL48) as the only platform and are now also approved for the Dako Omnis platform. This enables pathology laboratories to consolidate PD-L1 testing across more tumor types within a single automated Dako Omnis workflow, supporting increased automation and operational efficiency.
Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division, stated: "Pathology laboratories are increasingly looking to standardize testing on automated platforms that fit seamlessly into daily workflow. By expanding PD-L1 IHC 22C3 pharmDx on Dako Omnis for additional FDA-approved indications, we’re helping labs deliver PD-L1 results more conveniently and efficiently, supporting clinicians as they identify patients who may be eligible for immunotherapy."
To support expanded use of PD-L1 IHC 22C3 pharmDx on Dako Omnis, Agilent conducted a multisite external platform performance comparison study evaluating concordance of PD-L1 IHC 22C3 pharmDx results across staining platforms (Code SK006 on the ASL48 platform and Code GE006 on Dako Omnis) for the four additional indication specimens. Study results met acceptance criteria to demonstrate inter-platform concordance for these specimens when assessed at the appropriate CPS cutoffs.
PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck & Co. (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
(Press release, Agilent, JUN 2, 2026, View Source [SID1234666390])