Agilent Technologies has received European Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for its PD-L1 IHC 28-8 pharmDx (Code SK005).
The companion diagnostic (CDx) assay was previously CE-IVD marked for sale in the European Union (EU). It is now fully certified as per the new EU Regulation for IVDR.
The PD-L1 IHC 28-8 pharmDx assay is designed for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.
PD-L1 IHC 28-8 pharmDx provides clinically relevant insights into PD-L1 expression, a vital biomarker for predicting responses to therapies with anti-PD-1 therapies. These therapies include Opdivo (nivolumab), which shows therapeutic benefits across multiple cancer types, and Opdualag (nivolumab and relatimab).
The assay has received European IVDR certification for nine cancer indications.
These include five companion diagnostic indications in non-small cell lung cancer (NSCLC), muscle invasive urothelial carcinoma (MIUC), melanoma, oesophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ), and oesophageal adenocarcinoma.
Agilent Technologies life sciences and diagnostics markets group senior vice president Simon May said: “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.”
CDx assays identify patients who are most likely to benefit from specific drug treatments, providing critical clinical support for starting suitable therapies.
IVDR-compliant CDx ensures that EU laboratories using Agilent products in their diagnostic workflows can continue using them without disruption.
Agilent Technologies offers a range of solutions including instruments, software, services, and expertise.
In August 2023, the laboratory technologies developer announced the issuing of a CDx Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006. This assay helps identify cancer patients eligible for treatment with Merck’s Keytruda (pembrolizumab) and Regeneron’s Libtayo (cemiplimab).
In 2021, Agilent Technologies received CE-IVD mark approval for PD-L1 IHC 28-8 pharmDx, to guide first-line treatment options for adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or oesophageal cancers.
