Agilent Secures FDA Nod for PD-L1 Assay in Gastric and Esophageal Cancers
Event summary
- Agilent received FDA approval for PD-L1 IHC 28-8 pharmDx as a companion diagnostic for esophageal and gastric cancers.
- The assay identifies patients eligible for Bristol Myers Squibb’s OPDIVO® and OPDIVO QVANTIG® immunotherapies.
- Approval expands the assay’s use to include esophageal squamous cell carcinoma, gastric, gastroesophageal junction, and esophageal adenocarcinoma.
- Agilent’s Autostainer Link 48 is the exclusive staining solution for this diagnostic.
The big picture
Agilent’s FDA approval strengthens its position in precision oncology, aligning with the growing trend of biomarker-driven immunotherapy. The expansion of PD-L1 IHC 28-8 pharmDx supports Agilent’s long-term strategy in drug-diagnostic co-development, particularly as immunotherapies like OPDIVO® gain traction in treating high-mortality cancers.
What we're watching
- Market Adoption
- How quickly pathologists and clinicians integrate the assay into treatment workflows for gastric and esophageal cancers.
- Competitive Dynamics
- Whether Agilent can maintain its leadership in immunohistochemistry diagnostics amid rising competition.
- Regulatory Expansion
- The pace at which similar approvals are secured for other cancer types or regions outside the U.S.
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