Agilent gets EU approval for ovarian cancer companion diagnostic

Agilent Technologies (NYSE: A) has received European Union certification for its PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic for identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who may be eligible for treatment with Merck's KEYTRUDA® (pembrolizumab).

The certification marks the eighth CE-marked companion diagnostic indication for PD-L1 IHC 22C3 pharmDx, Code SK006, in the EU. The diagnostic enables pathologists to assess PD-L1 expression in tumor samples to help determine patient eligibility for pembrolizumab treatment in the platinum-resistant setting.

PD-L1 expression in the relevant cancer types was evaluated using the diagnostic in the KEYNOTE-B96/ENGOT-ov65 clinical trial.

The product was developed by Agilent in partnership with Merck, known as MSD outside the United States and Canada. It is also approved in the EU as a companion diagnostic across several other tumor types, including non-small cell lung cancer, esophageal cancer, cervical cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, gastric or gastroesophageal junction adenocarcinoma, and urothelial carcinoma.

Agilent reported revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide.

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