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Roche Secures CE IVDR Approval Enabling Identification Of HER2-Ultralow Breast Cancer Patients Eligible For ENHERTU Targeted Treatment Therapy

Author: Benzinga Newsdesk | September 05, 2025 01:29am

The VENTANA HER2 (4B5) test is now CE-IVDR approved to aid in the assessment of HER2-ultralow status to identify metastatic breast cancer patients who may be eligible for treatment with ENHERTU.
The VENTANA HER2 (4B5) test is also now approved to help identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA.
Roche continues to break ground as the leader in breast cancer diagnostics, helping to expand patient access to personalised treatment.

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