Summary:
- Roche has received CE-IVDR approval for its HER2 4B5 companion diagnostic test, which can identify patients with HER2-ultralow breast cancer and biliary tract cancer.
- This test helps healthcare providers determine which patients may benefit from targeted therapies for these types of cancers, as it can detect very low levels of the HER2 protein.
- The approval of this diagnostic test is an important step in personalized medicine, as it allows for more accurate identification of patients who may respond best to specific cancer treatments.