Roche Secures US FDA Approval for Expanded Use of HER2 DNA Probe Tests

11:24 PM EDT, 08/26/2026 (MT Newswires) -- Roche (RO.SW) received approval from the US Food and Drug Administration for the expanded use of its Pathway HER2 and Ventana HER2 Dual ISH DNA Probe Cocktail tests. The authorization allows the use of the diagnostic tests to determine HER2-positive status in metastatic gastroesophageal adenocarcinoma patients, according to a Wednesday release. The Swiss-listed pharmaceutical giant noted that there were previously no tests approved to check HER2 status in esophageal cancer. Roche added that the tests will help clinicians determine patients who may be eligible for treatment with Jazz Pharmaceuticals' Ziihera drug.