FDA approves Roche HER2 companion diagnostics for metastatic gastroesophageal adenocarcinoma
The FDA has expanded approval of two Roche HER2 companion diagnostics to identify patients with metastatic gastroesophageal adenocarcinoma who may be eligible for ZIIHERA treatment.
The PATHWAY HER2 4B5 assay and VENTANA HER2 Dual ISH DNA Probe Cocktail can now be used to assess HER2 status in metastatic gastric, gastroesophageal-junction and oesophageal adenocarcinoma.
The approvals strengthen the diagnostic infrastructure supporting biomarker-driven use of zanidatamab-hrii and reinforce the role of HER2 testing in gastrointestinal oncology.
Field | Content |
Alert Type | Approval |
Products | PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody; VENTANA HER2 Dual ISH DNA Probe Cocktail |
Company | Roche Diagnostics |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | Expanded companion diagnostic approval |
Indication | Identification of HER2-positive metastatic gastric, gastroesophageal-junction and oesophageal adenocarcinoma patients who may be eligible for ZIIHERA |
Associated Therapy | ZIIHERA (zanidatamab-hrii) |
Therapy Area(s) | Oncology; gastrointestinal cancer; precision diagnostics |
Biomarker | HER2 |
Technology or Modality | Immunohistochemistry and in-situ hybridisation companion diagnostics |
Geography | United States |
What Happened | The FDA expanded approval of two Roche HER2 diagnostic assays for use in metastatic gastroesophageal adenocarcinoma. |
Why It Matters | The approvals provide validated diagnostic tools for identifying patients whose tumours may respond to HER2-targeted treatment with ZIIHERA. |
Supporting Context | Accurate HER2 assessment is essential for selecting patients for HER2-directed therapies in gastric and gastroesophageal cancers. |
Key Takeaway | Roche's HER2 companion diagnostics now support patient selection for ZIIHERA in metastatic gastroesophageal adenocarcinoma. |
What to Watch | Testing uptake, integration into pathology workflows and broader use of HER2-targeted treatment in gastrointestinal cancers. |
Primary Source | Roche Diagnostics |
Relevant Date | 23 September 2026 |
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