Roche received FDA clearance expanding the use of its HER2 diagnostic tests tied to Jazz Pharmaceuticals’ Ziihera, extending patient identification beyond earlier approved stomach-cancer populations. The tests—PATHWAY HER2 and VENTANA HER2 Dual ISH—can now assess HER2-positive status in metastatic gastroesophageal adenocarcinoma including esophageal cancer settings. The expansion matters because it closes an access gap: Roche noted that until now, no tests had been approved to determine HER2 status in esophageal cancer for targeted therapy eligibility. The change increases the pool of patients who can be matched to Ziihera, potentially supporting broader adoption of the drug in clinical practice. The regulatory move also underscores how diagnostic label updates can drive downstream treatment access for expensive targeted oncology drugs, especially in late-stage, metastatic disease. With companion testing expanding, laboratories and oncology networks will need to ensure assay standardization and coverage alignment to meet patient enrollment and reimbursement needs.