Roche has received CE-IVDR approval for two label expansions of its VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx assay. The test can now aid in assessing HER2-ultralow status in metastatic breast cancer patients eligible for treatment with ENHERTU. It is also approved to help identify previously treated, unresectable, or metastatic HER2-positive biliary tract cancer patients eligible for treatment with ZIIHERA. This approval opens up new possibilities for targeted treatments in these patient populations. For more health news, visit rttnews.com.

Read more at Nasdaq: Roche Secures CE-IVDR Approval For Expanded VENTANA HER2 (4B5) Diagnostic Applications