FDA Approves Agilent's PD-L1 Test for Expanded Use on Dako Omnis Platform

Agilent Technologies announced it has received U.S. Food and Drug Administration (FDA) approval to expand the use of its PD-L1 IHC 22C3 pharmDx test on the Dako Omnis platform. The expanded indication allows for the identification of patients with esophageal squamous cell carcinoma, triple-negative breast cancer, cervical cancer, and gastric or gastroesophageal junction adenocarcinoma who may be eligible for treatment with KEYTRUDA® (pembrolizumab).

This approval adds to previously cleared indications for non-small cell lung cancer and head and neck squamous cell carcinoma. Previously, these indications were only available on the Autostainer Link 48 (ASL48) platform. The Dako Omnis approval enables pathology laboratories to consolidate PD-L1 testing for these multiple tumor types within a single automated workflow, supporting increased automation and operational efficiency.

According to Agilent, this expansion helps laboratories deliver PD-L1 results more conveniently and efficiently, supporting clinicians in identifying patients eligible for immunotherapy. The test was developed in partnership with Merck & Co. and serves as a companion diagnostic for KEYTRUDA.

A multi-site study demonstrated concordance for the PD-L1 IHC 22C3 pharmDx test results across the Dako Omnis and ASL48 platforms for the newly approved indications.