NEW YORK – Agilent Technologies said on Tuesday that its PD-L1 IHC 28-8 PharmDx test has received the European Union's In Vitro Diagnostic Regulation certification as a Class C device for use as a companion diagnostic test to aid cancer treatment decisions for therapies that contain anti-PD-1 antibodies.
The qualitative immunohistochemical assay is now IVDR certified for the detection of PD-L1 protein as a biomarker of potential response to therapies including Bristol Myers Squibb's Opdivo (nivolumab) and Opdualag (nivolumab and relatlimab). The firm said that it has received IVDR certification for the use of the test for nine cancer indications including five companion diagnostic indications, and it can be used to guide therapies for non-small cell lung cancer, muscle invasive urothelial carcinoma, melanoma, esophageal squamous cell carcinoma, and gastric, gastroesophageal junction, and esophageal adenocarcinoma.
Agilent also noted that the test is approved for exclusive use with the company's Autostainer Link 48 staining solution.
"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," Simon May, senior VP of Agilent's Life Sciences and Diagnostics Markets Group, said in a statement.
Under IVDR, Class C devices are considered to have high individual and moderate public health risk.
Agilent received CE-IVD marking for the test in 2021 and expanded CE-IVD marking in 2022.
The company also received in 2020 US Food and Drug Administration approval of the test as a companion diagnostic to aid the treatment of non-small cell lung cancer patients.