Roche secures FDA approval for HER2-ultralow metastatic breast cancer diagnostic

Roche has received FDA approval for an expanded use of its PATHWAY HER2 (4B5) test, marking a significant breakthrough in breast cancer diagnostics. This development makes it the first companion diagnostic tool capable of identifying patients with HER2-ultralow metastatic breast cancer, a newly defined category within HER2-negative breast cancer. With this approval, patients with hormone [̷