Agilent wins FDA approval for PD-L1 IHC 28-8 test in gastric and esophageal cancers - A News | RalliesAgilent wins FDA approval for PD-L1 IHC 28-8 test in gastric and esophageal cancers
A
A• FDA approval for companion diagnostic test
- Agilent won FDA clearance for its PD-L1 IHC 28-8 pharmDx test in certain gastric and esophageal cancers.
- The label supports use as a companion diagnostic to identify patients for Bristol Myers Squibb’s Opdivo or Opdivo Qvantig.
- The assay is authorized for detecting PD-L1 expression at CPS ≥ 1, run exclusively on Agilent’s Autostainer Link 48 system.
IBM
•