FDA Expands Test for Gastric and Esophageal Cancers - Takeaways - MDSpire
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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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  • 1

    The FDA approved Agilent Technologies' companion diagnostic for identifying tumors expressing PD-L1 in gastric and esophageal cancers.

  • 2

    The approval is for patients with esophageal squamous cell carcinoma, gastric tumors, gastroesophageal junction tumors, and esophageal adenocarcinoma.

  • 3

    The PD-L1 IHC 28-8 pharmDx assay is a diagnostic aid for detecting PD-L1 expression with a Combined Positive Score of 1 or greater.

  • 4

    Esophageal cancer is the 11th most common cancer globally, with over 510,000 new cases and 445,000 deaths annually.

  • 5

    Gastric cancer ranks fifth in global incidence, with approximately 968,000 new cases and 660,000 deaths each year.

Original Source(s)

FDA Expands Test for Gastric and Esophageal Cancers

  • by Kathryn Wighton

  • July 14, 2026

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