Agilent Technologies has received FDA approval for its PD-L1 IHC 22C3 pharmDx test as a companion diagnostic for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. The test helps identify patients whose tumors express PD-L1 and who may be eligible for treatment with Merck’s immunotherapy Keytruda (pembrolizumab).
This is the first immuno-oncology companion diagnostic approval for ovarian cancer and the seventh FDA-approved indication for the PD-L1 IHC 22C3 pharmDx test for use with Keytruda.
“Delivering effective precision oncology requires close collaboration between diagnostics and therapeutics, and this FDA approval reflects Agilent’s long-standing industry partnership in companion diagnostics,” said Nina Green, Vice President and General Manager of Agilent’s Clinical Diagnostics Division. “We are proud to enable pathologists to identify patients with EOC who may benefit from immunotherapy.”
PD-L1 expression in ovarian cancer was evaluated using the test in the KEYNOTE-B96 clinical trial.
In the United States, ovarian cancer caused approximately 12,730 deaths in 2025 and has a five-year survival rate of 51.6%.
The test is also indicated in the US for non-small cell lung cancer, esophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, and gastric or gastroesophageal junction adenocarcinoma.
