Roche’s Ventana HER2 (4B5) Test Receives CE Mark for HER2-Low Metastatic Breast Cancer

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Roche’s Ventana HER2 (4B5) Test Receives CE Mark for HER2-Low Metastatic Breast Cancer


  • Roche’s Ventana HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx has received the CE mark to identify metastatic breast cancer patients associated with low HER2 expression eligible for Enhertu. The US FDA approved the test in Oct 2022 under the brand name, PATHWAY
  • The Ventana HER2 (4B5) test works on a scoring algorithm that detects the patient population with less HER2 expression and grants them a HER2 low-status
  • The test is combined with the automated BenchMark IHC/ISH slide staining instrument to minimize errors. Additionally, it was utilized in the DESTINY-Breast04 program to diagnose breast cancer patients with low HER2 (IHC 1+ or IHC 2+/ISH-) eligible for Enhertu, leading to the product’s approval

Ref: PR Newswire | Image: Roche

Related News:- Roche Launches navify Digital Solutions for its Use in Laboratories and Point of Care Services at HIMSS 2024

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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