Agilent Expands FDA-Approved PD-L1 Testing on Dako Omnis for Multiple Cancer Types
Agilent Technologies has announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for its PD-L1 IHC 22C3 pharmDx assay, Code GE006, on the Dako Omnis platform. The approval broadens the use of the diagnostic test to help identify patients with several additional cancer types who may be eligible for treatment with KEYTRUDA® (pembrolizumab), one of the most widely used immunotherapy medicines.
The newly approved indications include esophageal squamous cell carcinoma (ESCC), triple-negative breast cancer (TNBC), cervical cancer, and gastric or gastroesophageal junction (GEJ) adenocarcinoma. The expansion represents a significant milestone for pathology laboratories and healthcare providers by enabling more comprehensive PD-L1 testing through a single automated workflow on the Dako Omnis platform.
PD-L1 testing plays a critical role in modern cancer care by helping physicians determine whether patients may benefit from certain immunotherapies. By measuring the expression of the PD-L1 protein in tumor samples, the test can provide valuable information that supports treatment decisions and helps identify patients who are more likely to respond to therapies such as KEYTRUDA.
With this latest FDA approval, Agilent is extending access to FDA-authorized PD-L1 testing across four additional tumor types beyond the previously approved indications for non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). The expansion allows pathology laboratories to perform testing for a broader range of cancers using the same automated diagnostic platform, improving efficiency and workflow consistency.
Previously, the FDA-approved PD-L1 IHC 22C3 pharmDx indications for these four cancer types were available only on the Autostainer Link 48 (ASL48) platform. The new approval now allows laboratories to perform these tests on the Dako Omnis system as well, providing greater flexibility and enabling laboratories to consolidate testing operations on a single platform.
The Dako Omnis platform is designed to automate staining and diagnostic processes used in pathology laboratories. By integrating multiple approved indications into one workflow, laboratories can streamline operations, reduce complexity, and potentially improve turnaround times for test results. Increased automation can also help laboratories manage growing testing volumes while maintaining high standards of quality and consistency.
According to Agilent, pathology laboratories are increasingly seeking automated solutions that simplify daily operations and support standardization across different testing procedures. The ability to perform PD-L1 testing for multiple cancer types on the Dako Omnis platform addresses these needs while helping laboratories improve operational efficiency.
Majken Nielsen, Vice President and General Manager of Agilent’s Clinical Diagnostics Division, emphasized the importance of workflow optimization and diagnostic standardization in today’s healthcare environment. She noted that pathology laboratories continue to look for solutions that integrate smoothly into routine laboratory operations and support efficient delivery of diagnostic results.
Nielsen stated that the expansion of PD-L1 IHC 22C3 pharmDx on Dako Omnis for additional FDA-approved indications helps laboratories provide PD-L1 testing more conveniently while supporting clinicians in identifying patients who may be eligible for immunotherapy treatment. The goal is to ensure that healthcare providers receive timely and reliable diagnostic information that can assist in making treatment decisions.
To support the expanded approval, Agilent conducted a comprehensive multisite external platform performance comparison study. The study evaluated the concordance of PD-L1 IHC 22C3 pharmDx results across the ASL48 and Dako Omnis staining platforms for the newly approved cancer indications.
Researchers compared results generated using Code SK006 on the ASL48 platform and Code GE006 on the Dako Omnis platform. The objective was to determine whether both systems produced consistent and reliable results when evaluating patient samples from the four additional cancer types.
According to Agilent, the study successfully met predefined acceptance criteria and demonstrated strong inter-platform concordance. The findings confirmed that the Dako Omnis platform delivers comparable PD-L1 testing results when assessed using the appropriate Combined Positive Score (CPS) thresholds for each indication. These results supported the FDA’s decision to expand approval of the assay to the Dako Omnis platform.
The newly approved indications cover several important cancer types where immunotherapy has become an increasingly important treatment option.
For patients with esophageal squamous cell carcinoma, the test can help identify individuals with locally advanced or metastatic disease whose tumors express PD-L1 at specified levels and who may be candidates for treatment with KEYTRUDA after previous systemic therapies.
In triple-negative breast cancer, PD-L1 testing can assist in identifying patients with locally recurrent unresectable or metastatic disease whose tumors meet the required PD-L1 expression criteria for treatment with KEYTRUDA in combination with chemotherapy.
The approval also includes cervical cancer, where the assay can help identify patients with recurrent or metastatic disease that has progressed following chemotherapy and whose tumors express PD-L1 at the required threshold for treatment consideration.
Additionally, the expanded indication covers gastric and gastroesophageal junction adenocarcinoma. In these cancers, PD-L1 testing can help determine eligibility for first-line treatment regimens that combine KEYTRUDA with trastuzumab and chemotherapy in patients whose tumors meet specified biomarker requirements.
PD-L1 IHC 22C3 pharmDx was originally developed through a collaboration between Agilent and Merck & Co., known as MSD outside the United States and Canada. The diagnostic assay serves as a companion diagnostic for KEYTRUDA, meaning it is specifically designed to provide information that supports the safe and effective use of the therapy.
Companion diagnostics have become increasingly important in precision medicine because they help match patients with treatments that are most likely to benefit them. By identifying specific biomarkers within tumors, these tests enable a more personalized approach to cancer care and help guide treatment decisions based on individual patient characteristics.
The expansion of PD-L1 testing on Dako Omnis reflects broader trends within oncology toward biomarker-driven treatment strategies and greater use of immunotherapies. As the number of approved cancer indications for immune checkpoint inhibitors continues to grow, healthcare providers and laboratories require reliable, efficient testing solutions capable of supporting increasingly complex treatment decisions.
For pathology laboratories, the ability to consolidate multiple FDA-approved PD-L1 testing indications onto a single automated platform offers operational advantages while helping maintain consistency in diagnostic processes. For clinicians and patients, expanded access to standardized PD-L1 testing may support more efficient identification of individuals who could benefit from immunotherapy-based treatment approaches.
With the FDA’s latest approval, Agilent strengthens the role of the Dako Omnis platform in precision oncology and expands the availability of companion diagnostic testing for several major cancer types. The approval underscores the company’s ongoing commitment to supporting personalized cancer care through innovative diagnostic solutions that help connect patients with appropriate treatment options.
About Agilent Technologies
Agilent Technologies, is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers’ most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide.
