Agilent Expands FDA-Approved PD-L1 Testing to Four New Cancer Types — Agilent Technologies, Inc.

Event summary

FDA approved expanded use of Agilent's PD-L1 IHC 22C3 pharmDx on Dako Omnis for esophageal squamous cell carcinoma, triple-negative breast cancer, cervical cancer, and gastric/gastroesophageal junction adenocarcinoma.
Approval enables pathology labs to consolidate PD-L1 testing across multiple tumor types on a single automated platform.
Agilent conducted a multisite study demonstrating inter-platform concordance for the new indications.
PD-L1 IHC 22C3 pharmDx is a companion diagnostic for Merck's KEYTRUDA (pembrolizumab).

The big picture

This approval represents a strategic win for Agilent in the growing precision oncology market, where PD-L1 testing is critical for identifying patients suitable for immunotherapy. The consolidation of testing on a single automated platform addresses a key operational need for pathology labs, potentially increasing efficiency and reducing costs. The partnership with Merck further strengthens Agilent's position in the companion diagnostics space, where regulatory approvals directly impact treatment access for cancer patients.

What we're watching

Adoption Pace: How quickly pathology labs will transition to the Dako Omnis platform for these new indications.
Market Expansion: Whether this approval will drive increased demand for KEYTRUDA across these additional cancer types.
Competitive Response: How competitors in the PD-L1 diagnostics space will react to Agilent's expanded platform capabilities.