FDA Expands Test for Gastric and Esophageal Cancers - Summary - MDSpire

FDA Expands Test for Gastric and Esophageal Cancers

According to Agilent Technologies, the expanded indication covers esophageal and gastric tumor types and applies to patients being considered for nivolumab or nivolumab and hyaluronidase-nvhy.

  • By

  • Kathryn Wighton

  • July 14, 2026

  • 2 min

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Objective:

To identify patients whose tumors express programmed death ligand 1 (PD-L1) for potential treatment eligibility with nivolumab or nivolumab and hyaluronidase-nvhy.

Approach:
  • Diagnostic Approval: The FDA approved Agilent Technologies' PD-L1 IHC 28-8 pharmDx assay for use with the Agilent Autostainer Link 48.
Key Findings:
  • The assay is designed for patients with esophageal squamous cell carcinoma, gastric tumors, gastroesophageal junction tumors, and esophageal adenocarcinoma.
  • A Combined Positive Score of 1 or greater indicates PD-L1 expression suitable for treatment consideration, measuring PD-L1 staining in tumor and immune cells relative to the total number of viable tumor cells.
  • Esophageal cancer has over 510,000 new cases and 445,000 deaths annually; gastric cancer has approximately 968,000 new cases and 660,000 deaths.
Interpretation:

The PD-L1 IHC 28-8 pharmDx assay serves as a diagnostic aid in identifying patients for potential treatment with nivolumab or nivolumab and hyaluronidase-nvhy.

Conclusion:

The assay assists pathologists and clinicians in making treatment decisions for patients with specific cancer types.

Sources:

Original Source(s)

FDA Expands Test for Gastric and Esophageal Cancers

  • by Kathryn Wighton

  • July 14, 2026

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