Roche said on Wednesday the U.S. Food and Drug Administration approved its PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail tests as companion diagnostics for metastatic gastroesophageal adenocarcinoma (GEA).
The expanded approval covers HER2-positive status assessment in gastric, gastroesophageal junction, and esophageal adenocarcinoma, areas where no prior FDA-approved tests existed for esophageal cancer. The assays were previously cleared for breast and gastric cancers.
The move supports clinicians in identifying patients who may qualify for Jazz Pharmaceuticals’ zanidatamab-based therapy, ZIIHERA, which is approved in two regimens for first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma.
Roche Diagnostics said the approval broadens access to targeted therapy by leveraging its widely available HER2 assay platform. Laura Apitz, Head of Pathology Lab at Roche Diagnostics, noted the expansion adds gastroesophageal adenocarcinoma to the assay’s indications, increasing the eligible patient population for targeted interventions.
Gastric cancer ranks as the fifth leading cause of cancer deaths globally, while esophageal cancer is the sixth, underscoring the clinical significance of improved diagnostic tools in these indications.
The PATHWAY HER2 (4B5) test is an immunohistochemistry primary antibody integrated into the VENTANA BenchMark slide staining platform. The VENTANA HER2 Dual ISH DNA Probe Cocktail uses dual-color technology to detect HER2 gene amplification.
