Agilent Technologies, a global provider of analytical and clinical laboratory technologies, has announced that the US Food and Drug Administration (FDA) has approved the expanded use of PD-L1 IHC 22C3 pharmDx, Code GE006, on the Dako Omnis platform. The approval will help identify patients in the United States with Esophageal Squamous Cell Carcinoma (ESCC), Triple-Negative Breast Cancer (TNBC), cervical cancer and gastric or Gastroesophageal Junction (GEJ) adenocarcinoma who may be eligible for treatment with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.

The approval extends access to PD-L1 testing beyond the previously approved indications of Non-Small Cell Lung Cancer (NSCLC) and Head and Neck Squamous Cell Carcinoma (HNSCC). Until now, these FDA-approved PD-L1 IHC 22C3 pharmDx indications were available only on the Autostainer Link 48 (ASL48) platform. With the new approval, they are also available on the Dako Omnis platform.

The expanded indication allows pathology laboratories to consolidate PD-L1 testing across multiple tumour types within a single automated Dako Omnis workflow, supporting greater automation and operational efficiency.

Majken Nielsen, Vice President and General Manager of Agilent’s Clinical Diagnostics Division, said that the pathology laboratories are increasingly seeking to standardise testing on automated platforms that integrate seamlessly into daily workflows. She noted that the expanded approval will help laboratories deliver PD-L1 test results more conveniently and efficiently, supporting clinicians in identifying patients who may be eligible for immunotherapy.

To support the expanded use of PD-L1 IHC 22C3 pharmDx on Dako Omnis, Agilent conducted a multisite external platform performance comparison study. The study evaluated concordance of PD-L1 IHC 22C3 pharmDx results across staining platforms, comparing Code SK006 on the ASL48 platform and Code GE006 on Dako Omnis for the four additional cancer indications.

According to the company, the study met acceptance criteria and demonstrated inter-platform concordance for the evaluated specimens when assessed using the appropriate Combined Positive Score (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.

Agilent Technologies develops instruments, software, services and laboratory solutions that support scientific research, diagnostics and clinical testing across global markets.