FDA approves Agilent test for ovarian cancer

Agilent has FDA approval for a test to identify ovarian cancer patients who may be eligible for immunotherapy.

Agilent’s PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to help identify patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumours express PD-L1 and who may be eligible for treatment with KEYTRUDA, Merck’s anti-PD-1 therapy.

A companion diagnostic is a test used alongside a specific treatment to show whether a patient is suitable for that therapy. PD-L1 is a protein on some cancer cells that helps tumours evade the immune system.

These cancers affect the reproductive system and the lining of the abdominal cavity.

The test enables pathologists to assess PD-L1 expression at diagnosis to support treatment decisions in a disease where options remain limited for many.

This is the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx for use with KEYTRUDA.

Nina Green, vice president and general manager of Agilent’s clinical diagnostics division, said: “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.”

PD-L1 expression with this test was evaluated in the KEYNOTE-B96 clinical trial supporting its use to identify patients who may benefit from KEYTRUDA.

In the US, ovarian cancer caused approximately 12,730 deaths in 2025 and the five-year survival rate was 51.6 per cent between 2015 and 2021.

In addition to these cancer types, the test is indicated in the US to help identify patients with non-small cell lung cancer, oesophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, triple-negative breast cancer and gastric or gastro-oesophageal junction adenocarcinoma who may benefit from treatment with KEYTRUDA.

The test was developed by Agilent with Merck as a companion diagnostic for KEYTRUDA.