Agilent Technologies has received European Union (EU) certification for its PD-L1 IHC 22C3 pharmDx, Code SK006 companion diagnostic, expanding its role in precision oncology by helping identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who may be eligible for treatment with Keytruda (pembrolizumab).

The CE-marked approval enables pathologists to assess PD-L1 expression in tumour samples, supporting treatment decisions in accordance with the approved prescribing information for pembrolizumab. The certification addresses an area of significant unmet need, where therapeutic options remain limited for many patients with advanced gynaecological cancers.

The latest approval marks the eighth CE-marked companion diagnostic indication for PD-L1 IHC 22C3 pharmDx, Code SK006 in the European Union, further expanding the test’s utility across multiple cancer types.

Commenting on the milestone, Majken Nielsen, Vice President and General Manager of Agilent’s Clinical Diagnostics Division, said, “Expanding access to precision oncology across regions is essential to improving patient outcomes. This EU approval builds on our commitment to deliver high-quality companion diagnostics and enables laboratories to support more informed treatment decisions for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.”

The certification is supported by findings from the KEYNOTE-B96/ENGOT-ov65 clinical trial, where PD-L1 expression in patients with epithelial ovarian, fallopian tube and primary peritoneal carcinoma was evaluated using PD-L1 IHC 22C3 pharmDx. The study supports the test’s use in identifying patients with platinum-resistant disease who may benefit from pembrolizumab therapy.

Beyond ovarian cancer, the diagnostic is already approved in the EU for use in identifying eligible patients for Keytruda treatment across several tumour types, including Non-Small Cell Lung Cancer (NSCLC), oesophageal cancer, cervical cancer, Head and Neck Squamous Cell Carcinoma (HNSCC), Triple-Negative Breast Cancer (TNBC), gastric or gastroesophageal junction adenocarcinoma and urothelial carcinoma.

PD-L1 IHC 22C3 pharmDx was developed through a collaboration between Agilent and Merck (known as MSD outside the United States and Canada) as a companion diagnostic for Keytruda, reinforcing the growing role of biomarker-driven diagnostics in advancing personalised cancer treatment.