Diagnostics expansion: Roche wins expanded FDA clearance for tests tied to Jazz’s Ziihera

Roche received expanded FDA authorization for companion diagnostics tied to Jazz Pharmaceuticals’ oncology drug Ziihera. The new clearance allows Roche’s PATHWAY HER2 and VENTANA HER2 Dual ISH DNA Probe tests to be used in the U.S. to identify HER2-positive status in metastatic gastroesophageal adenocarcinoma (GEA), including gastric, gastroesophageal junction, and esophageal cancers. Roche’s expansion builds on Ziihera’s recent FDA green light for first-line HER2-positive stomach cancer patients and its prior approval in adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The broader testing coverage widens the eligible patient pool for a targeted therapy increasingly dependent on accurate HER2 determination.