SANTA CLARA, Calif., June 2, 2026
Agilent Technologies announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of PD-L1 IHC 22C3 pharmDx on the Dako Omnis platform for patients with esophageal squamous cell carcinoma (ESCC), triple-negative breast cancer (TNBC), cervical cancer, and gastric or gastroesophageal junction (GEJ) adenocarcinoma. The approval enables pathology laboratories to use a single automated platform to identify patients who may be eligible for treatment with KEYTRUDA® (pembrolizumab), expanding access beyond the previously approved indications of non-small cell lung cancer and head and neck squamous cell carcinoma.
The FDA decision marks a significant advancement in companion diagnostics by allowing laboratories to perform PD-L1 testing across multiple tumor types using the Dako Omnis automated workflow. Previously, these indications were only available on the Autostainer Link 48 platform. By extending availability to Dako Omnis, Agilent aims to improve laboratory efficiency, streamline testing operations, and support faster clinical decision-making for oncologists selecting immunotherapy treatments. The approval reinforces the growing role of biomarker-driven diagnostics in precision oncology and personalized cancer care.
Supporting Precision Oncology Through Automated Testing
PD-L1 IHC 22C3 pharmDx serves as an FDA-approved companion diagnostic for Merck’s immunotherapy KEYTRUDA, helping clinicians determine whether patients are likely to benefit from treatment. The expanded indications cover several difficult-to-treat cancers, including advanced or metastatic ESCC, recurrent or metastatic cervical cancer, locally advanced or metastatic TNBC, and HER2-positive gastric or GEJ adenocarcinoma. These cancers often require accurate biomarker assessment to guide treatment strategies and optimize patient outcomes.
To support the expanded approval, Agilent conducted a comprehensive multisite external performance comparison study evaluating concordance between the Autostainer Link 48 and Dako Omnis platforms. Results demonstrated strong agreement across all tested tumor specimens and met predefined acceptance criteria at clinically relevant Combined Positive Score (CPS) thresholds. The findings confirmed that laboratories can achieve consistent and reliable PD-L1 testing results regardless of the approved platform used, ensuring confidence in treatment selection decisions.
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Enhancing Laboratory Efficiency and Patient Access
According to Agilent, pathology laboratories are increasingly seeking automated solutions that integrate seamlessly into routine diagnostic workflows. The Dako Omnis platform offers advanced automation capabilities that help laboratories standardize testing processes while maintaining high-quality results. Expanding PD-L1 IHC 22C3 pharmDx to additional cancer indications on Dako Omnis allows institutions to consolidate testing activities, reduce operational complexity, and improve turnaround times for clinicians and patients.
Agilent executives emphasized that broader access to automated PD-L1 testing can help healthcare providers identify eligible immunotherapy candidates more efficiently. As precision medicine continues to reshape oncology treatment paradigms, diagnostic technologies that support accurate biomarker assessment remain critical for matching patients with targeted therapies. The latest approval further strengthens Agilent’s position in companion diagnostics and highlights the company’s long-standing collaboration with Merck in advancing personalized cancer care.
Growing Role of Companion Diagnostics in Cancer Treatment
The expanded FDA approval underscores the increasing importance of companion diagnostics in modern oncology. As immunotherapies become standard treatment options across a wider range of cancers, reliable biomarker testing is essential for identifying patients most likely to respond to therapy. By enabling broader use of PD-L1 testing within a single automated workflow, Agilent is helping laboratories adapt to growing testing demands while supporting precision treatment decisions.
With a portfolio spanning analytical instruments, clinical diagnostics, software, and laboratory solutions, Agilent continues to invest in technologies that advance personalized healthcare. The latest FDA milestone reflects the company’s commitment to improving diagnostic efficiency and supporting the expanding use of immunotherapy across multiple cancer indications.
Source: Agilent Technologies, press release
