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ERBB2 (HER2)

Biomarker

HER2 is a growth factor receptor involved in cell proliferation and survival. Overexpression or amplification is a key therapeutic target in breast, gastric, and other cancers.

Approvals
22
Indications
4
Therapies
6
Mapped tests
9

Where this biomarker is used

Each approval combines this biomarker with a specific indication and therapy. Select a therapy in the tables below to open its FDA-defined testing pathway.

Indication-specific approvals

Approvals where ERBB2 (HER2) is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Biliary Tract Cancer
Solid Tumor · Biliary
  • HER-2 protein overexpression
ZIIHERA
Breast Cancer
Solid Tumor · Breast
  • gene amplification
  • HER2 ultralow expression (IHC 0 with membrane staining)
  • HER2-low expression (IHC 1+ or IHC 2+/ISH non-amplified)
  • HER-2 protein overexpression
HERCEPTINENHERTUKADCYLAPERJETA
Gastric and Gastroesophageal Cancer
Solid Tumor · Stomach/GEJ
  • HER-2 protein overexpression
  • gene amplification
HERCEPTIN
Non-Small Cell Lung Cancer (NSCLC)
Solid Tumor · Lung
  • Activating mutations in the tyrosine kinase domain (SNVs in exons 18-21 and exon 20 insertions)
  • Activating Mutations (SNVs And Exon 20 Insertions)
HERNEXEOSENHERTU
Tumor-agnostic approvals

Approvals defined at the solid tumor level where ERBB2 (HER2) is part of the eligibility criteria.

No tumor-agnostic approvals are currently mapped for this biomarker.

Tests that measure this biomarker

These assays report ERBB2 (HER2) as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
Bond Oracle HER2 IHC System
Leica Biosystems
Method
IHC
Specimen
Tissue (FFPE)

Reports ERBB2 (HER2) as part of its biomarker panel.

1 approvalView test profile →
Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)

Reports ERBB2 (HER2) as part of its biomarker panel.

3 approvalsView test profile →
Test
Guardant360 CDx
Guardant Health, Inc.
Method
NGS
Specimen
Plasma

Reports ERBB2 (HER2) as part of its biomarker panel.

1 approvalView test profile →
Test
HER2 FISH pharmDx Kit
Dako Denmark A/S
Method
FISH
Specimen
Tissue (FFPE)

Reports ERBB2 (HER2) as part of its biomarker panel.

4 approvalsView test profile →
Test
HercepTest
Dako Denmark A/S
Method
IHC
Specimen
Tissue (FFPE)

Reports ERBB2 (HER2) as part of its biomarker panel.

4 approvalsView test profile →
Test
Oncomine Dx Target Test
Life Technologies Corporation
Method
NGS
Specimen
Tissue (FFPE)

Reports ERBB2 (HER2) as part of its biomarker panel.

2 approvalsView test profile →
Test
PathVysion HER-2 DNA Probe Kit
Abbott Molecular, Inc.
Method
FISH
Specimen
Tissue (FFPE)

Reports ERBB2 (HER2) as part of its biomarker panel.

1 approvalView test profile →
Test
PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc.
Method
IHC
Specimen
Tissue (FFPE)

Reports ERBB2 (HER2) as part of its biomarker panel.

5 approvalsView test profile →
Test
Ventana HER2 Dual ISH DNA Probe Cocktail
Ventana Medical Systems, Inc.
Method
ISH
Specimen
Tissue (FFPE)

Reports ERBB2 (HER2) as part of its biomarker panel.

1 approvalView test profile →
This view is scoped to ERBB2 (HER2). You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.