Roche Obtains CE-IVDR Certification for Broadened Uses of VENTANA HER2 (4B5) Diagnostic Tests
Written by Emily J. Thompson, Senior Investment Analyst
Source: NASDAQ.COM
Updated: Sep 05 2025
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Source: NASDAQ.COM
Roche's CE-IVDR Approval: Roche has received CE-IVDR approval for two label expansions of its VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx assay.
Applications of the Test: The test is now approved for assessing HER2-ultralow status in metastatic breast cancer patients eligible for ENHERTU and for identifying patients with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer eligible for ZIIHERA.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
