Roche nabs expanded FDA approval for diagnostic tied to Jazz’s cancer drug

MedTech Roche nabs expanded FDA approval for diagnostic tied to Jazz’s cancer drug By Ben Adams Aug 27, 2026 8:00am Roche Jazz Pharmaceuticals FDA Diagnostics Roche has won an extended clearance by the FDA for its tests that can find patients eligible to use Jazz Pharmaceuticals’ oncology med Ziihera. The drug just this week got a new FDA green light for first-line HER2-positive stomach cancer patients. This builds on its 2024 U.S.

approval in adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer. Roche’s two tests, PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail, can now be used in the U.S. to assess HER2-positive status in metastatic gastroesophageal adenocarcinoma (GEA) patients, including those with gastric, gastroesophageal junction, and esophageal adenocarcinoma.

Related Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test This is specific for doctors who want to find patients who could benefit the most from Ziihera. These types of cancers are typically aggressive and found late, Roche notes. Until now, Roche adds that “no tests had been approved to determine HER2 status in esophageal cancer, meaning patients were unable to access targeted therapy.” Roche Jazz Pharmaceuticals FDA Diagnostics MedTech