Roche receives expanded FDA clearance for HER2 diagnostic tests linked to Jazz’s Ziihera cancer drug

Roche announced that the U.S. Food and Drug Administration has broadened the clearance for two of its HER2 diagnostic assays, allowing their use in metastatic gastroesophageal adenocarcinoma.

The assays – PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail – can now determine HER2‑positive status in patients with gastric, gastroesophageal junction and esophageal adenocarcinomas, a setting where no FDA‑cleared test previously existed.

The expanded indication aligns with Jazz Pharmaceuticals’ HER2‑targeted therapy Ziihera, which recently received FDA approval for first‑line treatment of HER2‑positive stomach cancer and builds on its 2024 approval for biliary tract cancer.

Roche said the new diagnostic availability should help clinicians identify patients who are most likely to benefit from Ziihera, addressing an unmet need in aggressive cancers that are often diagnosed late.