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Roche receives CE IVDR approval for HER2 (4B5) companion diagnostic test to identify HER2-ultralow breast cancer and biliary tract cancer patients

Summary by The Billings Gazette
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…

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Helena Independent RecordHelena Independent Record
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Roche receives CE IVDR approval for HER2 (4B5) companion diagnostic test to identify HER2-ultralow breast cancer and biliary tract cancer patients

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…

·Helena, United States
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The Billings Gazette broke the news in Billings, United States on Friday, September 5, 2025.
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