FDA Approves Agilent PD-L1 Test

The United States — Food and Drug Administration has approved the expanded use of General Atomics' PD-L1 IHC 22C3 pharmDx, Code GE006, on the Agilent Technologies — Dako Omnis platform. This approval allows the diagnostic test to identify 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 Pembrolizumab, Merck & Co.'s anti-PD-1 therapy. This expansion adds four new tumor types to the previously approved indications, enabling pathology laboratories to consolidate PD-L1 testing on a single automated workflow, thereby enhancing operational efficiency. The diagnostic was developed by General Atomics in partnership with Merck & Co. as a companion diagnostic for Pembrolizumab.