Five reasons why our HER2 (4B5) assay continues to be the trusted diagnostic assay of choice

Roche’s portfolio of immunohistochemistry (IHC) and in situ hybridization (ISH) breast cancer diagnostic assays provide high sensitivity, specificity and consistency. We continue to innovate to broaden clinical utility of these assays to include new indications – and support clinicians in making decisions that lead to better care for more patients.

Here are five reasons why the Roche HER2 (4B5) assay¹ remains the trusted IHC predictive assay of choice for laboratories and clinicians alike.

• HER2 (4B5) antibody has shown the most consistent performance when compared to other on-market HER2 clones²
• Achieve consistently high proficiency assessment scores with HER2 (4B5) antibody, compared to other clones²

• Registered and commercialized in more than 100 countries
• The Roche HER2 (4B5) assay runs on Benchmark IHC/ISH instruments, one of the largest installed bases of IHC/ISH staining platforms globally³
• Partnership with Roche connects you with an established global network with expert local support capabilities

• US FDA-approved to identify breast cancer patients who may be eligible for Herceptin® (trastuzumab), KADCYLA® (ado-trastuzumab emtansine) and now ENHERTU® (trastuzumab deruxtecan)⁴
• CE IVDR-approved to identify breast cancer patients who may be eligible for Herceptin (trastuzumab), KADCYLA (ado-trastuzumab emtansine), PERJETA® (pertuzumab) and now ENHERTU (trastuzumab deruxtecan)⁵
• US FDA and CE IVDR-approved to identify biliary tract cancer patients who may be eligible for ZIIHERA® (zanidatamab)^4,5
• Approved in ex-US markets to identify gastric cancer patients who may be eligible for Herceptin (trastuzumab)⁵
• US FDA-approved to identify patients with metastatic gastroesophageal adenocarcinoma eligible for ZIIHERA⁶
• Ongoing collaborations to expand the Roche HER2 (4B5) assay to aid in identifying patients with other cancer types who may be eligible for targeted therapy

• uPath HER2 (4B5) image analysis breast algorithm is validated for use with the VENTANA® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and CE marked for use as an aid in the assessment of breast cancer patients for whom Herceptin (trastuzumab), KADCYLA (ado-trastuzumab emtansine) or PERJETA (pertuzumab) treatments are being considered⁷
• Pathologist trained artificial intelligence algorithm allows for quick analysis and provides objective and reproducible results to support confident decision-making⁷
• Whole slide analysis (WSA) with automated pre-computing of the entired slide image prior to pathologist assessment provides fast results for user-defined regions of interest (ROI)⁷

• Automated workflow requires minimal hands-on time for high-quality staining
• Automation increases efficiency and productivity, allowing laboratory staff to focus on other value-added tasks
• Ready-to-use, ensuring accurate, repeatable results with no calculations, dilutions, or pipetting⁴
• Fewer touch-points reduce the potential for human error while increasing safety, due to limited exposure to chemicals⁴