Agilent Technologies has secured European Union (EU) certification for its key cancer diagnostic, expanding access to precision treatment decisions.
PD-L1 IHC 22C3 pharmDx, Code SK006 as a companion diagnostic helps identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who may be eligible for treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.
The certification marks a significant expansion of Agilent’s precision oncology portfolio, enabling pathologists to assess PD-L1 expression and support treatment decisions for patients facing limited therapeutic options in these difficult-to-treat cancers.
The newly approved indication is based on findings from the KEYNOTE-B96/ENGOT-ov65 clinical trial, in which PD-L1 expression was evaluated using PD-L1 IHC 22C3 pharmDx, Code SK006. The diagnostic test supports the identification of patients in the platinum-resistant setting who may benefit from pembrolizumab therapy in line with approved product labelling.
“Expanding access to precision oncology across regions is essential to improving patient outcomes,” said Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division.
“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.”
With this latest certification, PD-L1 IHC 22C3 pharmDx, Code SK006, now holds eight CE-marked companion diagnostic indications in the EU, reinforcing its role in guiding targeted cancer treatment decisions across multiple tumor types.
Beyond ovarian, fallopian tube, and primary peritoneal carcinoma, the diagnostic is also approved in the EU to help identify patients across a range of cancers — including non-small cell lung cancer (NSCLC), esophageal cancer, cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, and urothelial carcinoma.
