NEW YORK – Agilent Technologies said on Monday that it has received certification under the EU's In Vitro Diagnostic Regulation for the expanded use of a PD-L1 assay as a companion diagnostic test to help guide cancer treatment decisions.
The Santa Clara, California-based company said that its PD-L1 IHC 28-8 PharmDx assay has been certified for use as a companion diagnostic test to help determine whether patients with early-stage non-small cell lung cancer are likely to respond to treatment with Bristol-Myers Squibb's Opdivo (nivolumab) as well as whether patients with previously untreated advanced melanoma are likely to respond to Bristol-Myers Squibb's Opdualag (nivolumab and relatlimab).
"The two added indications of PD-L1 IHC 28-8 PharmDx will give physicians in Europe critical information to inform treatment decisions for patients with these common and potentially deadly cancers," Simon May, senior vice president of Agilent's Life Sciences and Diagnostics Markets Group, said in a statement.
The PD-L1 IHC 28-8 PharmDx immunohistochemical assay is used for the detection of PD-L1 protein to predict patient response to anti-PD-1 therapies, and it is designed for use with the Agilent Autostainer Link 48 instrument. The test was CE-IVD-marked in 2021 as a companion diagnostic to guide the use of Opdio as a treatment for metastatic gastric, gastroesophageal junction, or esophageal cancers and received expanded CE-IVD marking in 2022 to guide treatment of esophageal squamous cell carcinoma and muscle-invasive urothelial carcinoma.
The firm also announced in December 2024 that the test had been IVDR certified as a Class C device for nine cancer indications including companion diagnostic indications for non-small cell lung cancer, muscle invasive urothelial carcinoma, melanoma, esophageal squamous cell carcinoma, and gastric, gastroesophageal junction, and esophageal adenocarcinoma.
The firm gained US Food and Drug Administration approval for the test in 2020.