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FDA-approved companion diagnostic

PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody

Semi-quantitative HER2 IHC antibody for FFPE breast and gastric tissue on BenchMark instruments to determine HER2 status for treatment planning.

IVD-developed CDxMethod: IHCSpecimen: Tissue (FFPE)Biomarker: HER2 (ERBB2) membrane protein expression
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P990081
Supplements
S039, S047, S054, S055
Manufacturer
Ventana Medical Systems, Inc. (Roche Diagnostics)
Approval date
November 28, 2000
Test specifications
Methodology
IHC
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
HER2 (ERBB2) membrane protein expression
What this test is

PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is an FDA-approved, semi-quantitative immunohistochemistry reagent for detecting HER2 antigen in formalin-fixed, paraffin-embedded breast and gastric tissue on VENTANA BenchMark IHC/ISH instruments. Using standardized 0–3+ membrane staining criteria, it classifies tumors by HER2 protein expression to support HER2-directed treatment decisions.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Biliary Tract CancerERBB2 (HER2)HER-2 protein overexpressionZIIHERA
Breast CancerERBB2 (HER2)HER-2 protein overexpressionHERCEPTIN, KADCYLA
HER2 ultralow expression (IHC 0 with membrane staining)ENHERTU
HER2-low expression (IHC 1+ or IHC 2+/ISH non-amplified)ENHERTU

IVD Manufacturer

Ventana Medical Systems, Inc. (Roche Diagnostics)

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

Order this test

If your organization is connected to Casandra, you can place an electronic order forPATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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