Agilent companion diagnostic expands CE-IVD mark in Europe

Published: 31-Aug-2021

The assay is now approved as an aid to identify oesophageal cancer patients for treatment with Merck MSD’s Keytruda therapy

Agilent Technologies has announced its PD-L1 IHC 22C3 pharmDx assay is now CE-IVD marked for use as an aid in identifying oesophageal cancer patients for treatment with Keytruda using Combined Positive Score (CPS) ≥ 10.1 In Europe, the therapy is approved in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with locally advanced unresectable or metastatic oesophageal carcinoma or HER2 negative gastroesophageal junction adenocarcinoma whose tumours express PD-L1 [Combined Positive Score (CPS) ≥ 10].2

“PD-L1 has been established as an essential biomarker for anti-PD-1 therapies like Keytruda,” said Sam Raha, President of Agilent’s Diagnostics and Genomics Group. “Pathologists’ confidence in their PD-L1 test is critical, as a growing number of patients are becoming eligible for treatment with these therapies. With expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent can provide pathologists with the quality, reliability, and accuracy they need to ensure diagnostic confidence.”

In Europe, almost 53,000 people were diagnosed with oesophageal cancer in 2020, and this type of cancer caused more than 45,000 deaths the same year.3

Keytruda is a humanised monoclonal antibody that enhances the ability of the immune system to detect and fight tumour cells. It blocks the PD-1 pathway, thereby activating T lymphocytes that may affect both tumour cells and healthy cells.2 PD-L1 IHC 22C3 pharmDx was developed by Agilent as a companion diagnostic for the treatment in partnership with Merck MSD.


1. PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2021.

2. Keytruda [Summary of Product Characteristics]. European Medicines Agency; 2021.

3. World Health Organization. Global Cancer Observatory. (accessed August 10, 2021).

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