Agilent Technologies Inc. (NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for PD-L1 IHC 28-8 pharmDx (Code SK005). This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR) 1. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.
Agilent’s PD-L1 IHC 28-8 pharmDx (Code SK005) provides clinically relevant information about PD-L1 expression – a critical biomarker for potential response to therapies containing anti-PD-1 antibodies such as OPDIVO® (nivolumab) which has demonstrated therapeutic value across growing list of cancer types and OpdualagTM (nivolumab and relatimab).
PD-L1 IHC 28-8 pharmDx (Code SK005) has received European IVDR certification for nine cancer indications, including five companion diagnostic indications; non-small cell lung cancer (NSCLC), muscle invasive urothelial carcinoma (MIUC), melanoma, esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ) and esophageal adenocarcinoma.
Simon May, senior vice president of Agilent’s Life Sciences and Diagnostics Markets Group, commented on this important achievement: “The IVDR certification of PD-L1 IHC 28-8 pharmDx as a Class C-CDx device is critical to our CDx assays and enhances the confidence of healthcare professionals and patients in the EU by showing that these medical devices can be safely relied upon.”
Companion diagnostic (CDx) assays are medical devices used to help identify patients most likely to benefit from a specific drug treatment, thus offering key clinical support for the enablement of appropriate medicines. Access to IVDR-compliant CDx ensures that laboratories in the EU, who rely on Agilent products in their diagnostic workflows, can continue to use those products without disruption.
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company; OpdualagTM is a trademark of Bristol-Myers Squibb Company.
1 Regulation (EU) 2017/746 In Vitro Diagnostic Medical Devices Regulation (europa.eu)