Regulatory and diagnostics—Roche expands FDA-cleared HER2 companion testing for Ziihera access

Roche received an expanded FDA clearance for diagnostic tests tied to Jazz Pharmaceuticals’ Ziihera, extending HER2 status assessment into additional gastric and gastroesophageal cancer settings. The update supports patient selection for a broader use label. Roche said its PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail can now be used for assessing HER2-positive status in metastatic gastroesophageal adenocarcinoma, including gastric, gastroesophageal junction, and esophageal cancers. For labs and oncologists, the decision reduces gaps in access to targeted treatment eligibility where earlier testing approvals did not cover esophageal cancer.