FDA Approves Agilent's PD-L1 Test for Ovarian Cancer Treatment Decisions
The U.S. Food and Drug Administration (FDA) has approved Agilent Technologies' PD-L1 IHC 22C3 pharmDx test for use in patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC).
Santa Clara, Calif. – Agilent Technologies announced that the U.S. Food and Drug Administration (FDA) has approved its PD-L1 IHC 22C3 pharmDx diagnostic test to aid in treatment decisions for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) using KEYTRUDA® (pembrolizumab).
This approval designates the test as the sole FDA-approved companion diagnostic for identifying EOC patients whose tumors express PD-L1 and may be eligible for treatment with Merck's anti-PD-1 therapy. This marks the seventh FDA-approved indication for Agilent's PD-L1 IHC 22C3 pharmDx test used in conjunction with KEYTRUDA.
The diagnostic allows pathologists to assess PD-L1 expression at the time of diagnosis, supporting informed treatment choices in a disease with limited options for many. Agilent highlighted this as the first immuno-oncology approval for this specific cancer type.
PD-L1 IHC 22C3 pharmDx was developed in partnership with Merck & Co. as a companion diagnostic for KEYTRUDA. Ovarian cancer caused approximately 12,730 deaths in the U.S. in 2025. The test is also indicated for other cancers, including non-small cell lung cancer, esophageal squamous cell carcinoma, and head and neck squamous cell carcinoma.