Agilent Receives European Approval for New Diagnostic Test

Agilent Technologies has achieved CE-Conformity marking for its new PD-L1 IHC 22C3 pharmDx companion diagnostic assay within the European Economic Area. This assay is designed to identify patients with advanced non-small cell lung cancer (NSCLC) who are likely to respond to treatment with KEYTRUDA (pembrolizumab).

The diagnostic test was developed in partnership with Merck & Co. (known as MSD outside the U.S. and Canada) and is validated to guide immunotherapy targeting in advanced NSCLC patients. The European approval follows the U.S. approval received last year. NSCLC accounts for 80 percent of all lung cancers, which are the leading cause of cancer-related death worldwide.

According to Agilent, the PD-L1 IHC 22C3 pharmDx is the first and only companion diagnostic assay validated and approved to identify NSCLC patients eligible for KEYTRUDA treatment. The therapy is indicated for patients whose tumors express the PD-L1 biomarker and have received at least one prior chemotherapy regimen.

Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group, highlighted the assay's significance in personalized medicine. He expressed enthusiasm for Agilent's involvement in advancements in cancer treatment and the potential of PD-L1 IHC 22C3 pharmDx to identify patients who may benefit from KEYTRUDA therapy.