Roche Receives FDA Approval for Companion Diagnostic Tests for HER2-Positive GEA
Roche has received FDA approval for its PATHWAY® HER2 and VENTANA® HER2 Dual ISH DNA Probe Cocktail tests, allowing for the identification of HER2-positive patients with metastatic gastroesophageal adenocarcinoma (GEA) who may be eligible for treatment with Jazz Pharmaceuticals’ ZIIHERA®. This approval broadens treatment options for patients, as previously no tests existed to determine HER2 status in esophageal cancer.
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…