Roche receives FDA approval for companion diagnostic tests to identify patients with HER2-positive metastatic gastroesophageal adenocarcinoma eligible for ZIIHERA

Roche receives FDA approval for companion diagnostic tests to identify patients with HER2-positive metastatic gastroesophageal adenocarcinoma eligible for ZIIHERA

PR Newswire

TUCSON, Ariz., Aug. 26, 2026

The PATHWAY HER2 (4B5) test and VENTANA HER2 Dual ISH DNA Probe Cocktail help identify HER2-positive metastatic gastric, gastroesophageal junction and esophageal adenocarcinoma.Differential diagnosis of these cancers, often aggressive and diagnosed at an advanced stage, is critical to improving patient outcomes.Together, the tests enable precise assessment of HER2-positive status to help identify patients eligible for treatment with ZIIHERA.TUCSON, Ariz., Aug. 26, 2026 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for expanded use of its PATHWAY® HER2 (4B5) and VENTANA® HER2 Dual ISH DNA Probe Cocktail tests. These companion diagnostics are now approved to assess HER2-positive status in metastatic gastroesophageal adenocarcinoma (GEA) patients, including those with gastric, gastroesophageal junction, and esophageal adenocarcinoma. The approval enables clinicians to identify HER2-positive GEA patients who may be eligible for HER2-targeted treatment with Jazz Pharmaceuticals' ZIIHERA® (zanidatamab-hrii). Two ZIIHERA-containing regimens are now FDA approved for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive GEA.