Roche Secures CE-IVDR Approval For Expanded VENTANA HER2 (4B5) Diagnostic Applications
(RTTNews) - Roche (RHHBY) announced it has received CE-IVDR approval for two label expansions of its VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx assay.
The VENTANA HER2 (4B5) test is now CE-IVDR approved to aid in assessing HER2-ultralow status in metastatic breast cancer patients who may be eligible for treatment with ENHERTU. It is also 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.
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