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Agilent’s PD-L1 test gains FDA nod for ovarian cancer
This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA
- By IPP Bureau
| February 16, 2026
Agilent Technologies has announced a major FDA milestone: the agency has approved the diagnostic major's test for ovarian cancer.
The test enables pathologists to assess PD-L1 expression at the time of diagnosis, supporting informed treatment decisions in a disease where options remain limited. This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx 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. We are proud to enable pathologists to identify patients with EOC who may benefit from immunotherapy.
"As the first immuno-oncology approval for this disease, this milestone underscores our commitment to advancing precision medicine and expanding access to innovative cancer treatments worldwide,” said Nina Green, vice president and general manager of Agilent’s Clinical Diagnostics Division.
PD-L1 expression in EOC was evaluated in the KEYNOTE-B96 clinical trial, supporting its use in selecting patients likely to respond to KEYTRUDA. In the US, ovarian cancer claimed an estimated 12,730 lives in 2025 and has a five-year survival rate of just 51.6%.
Beyond EOC, PD-L1 IHC 22C3 pharmDx helps identify patients with 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 who may benefit from KEYTRUDA therapy.
