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

Our mission compels us to make even our best tools better.

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) assay¹remains the trusted IHC predictive assay of choice for laboratories and clinicians alike.

1. Globally proven to deliver optimal performance

HER2 (4B5) antibody² has shown the most consistent performance when compared to other on-market HER2 clones³
Achieve consistently high proficiency assessment scores with HER2 (4B5) antibody, compared to other clones³

2. Widely available

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 globally
Partnership with Roche connects you with an established global network with expert local support capabilities

3. Broad and expanding line of therapeutic indications

US FDA approved as a screening assay for breast cancer patients who may be eligible for Herceptin® (trastuzumab), KADCYLA® (ado-trastuzumab emtansine) and now ENHERTU® (trastuzumab deruxtecan)⁴
US FDA approved as a screening assay for biliary tract cancer patients who may be eligible for ZIIHERA® (zanidatamab) ⁴
CE IVD approved as a screening assay for breast cancer patients who may be eligible for Herceptin (trastuzumab), KADCYLA (ado-trastuzumab emtansine), PERJETA® (pertuzumab) and now ENHERTU (trastuzumab deruxtecan)⁵
Approved in ex-US markets as a screening assay for gastric cancer patients who may be eligible for Herceptin (trastuzumab)⁴
Ongoing collaboration to expand the Roche HER2 (4B5) assay to aid in identifying patients with other cancer types who may be eligible for targeted therapy

Comprehensive scoring algorithms for PD-L1 testing animation

The VENTANA PD-L1 (SP263) Assay is digital algorithm assisted

4. Digital algorithm assisted

The 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 considered
Pathologist trained artificial intelligence algorithm allows for quick analysis and provides objective and reproducible results to support confident decision-making
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)

5. Fully automated on BenchMark IHC/ISH platforms

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