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EGFR (HER1)

Biomarker

EGFR is a receptor tyrosine kinase frequently altered in non-small cell lung cancer. Specific activating mutations predict response to EGFR-targeted therapies, while resistance mutations inform subsequent treatment selection.

Approvals
46
Indications
2
Therapies
10
Mapped tests
10

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 EGFR (HER1) is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Colorectal Cancer (CRC)
Solid Tumor · Colorectal
  • protein expression
VECTIBIXERBITUX
Non-Small Cell Lung Cancer (NSCLC)
Solid Tumor · Lung
  • Exon 20 insertions
  • Exon 19 deletion or exon 21 L858R substitution mutation
  • L861Q, G719X and S7681
  • Exon 19 deletions or exon 21 L858R, and T790M
  • T790M
ZEGFROVYVIZIMPROLAZCLUZE + RYBREVANTGILOTRIFIRESSARYBREVANTTAGRISSOTARCEVA
Tumor-agnostic approvals

Approvals defined at the solid tumor level where EGFR (HER1) is part of the eligibility criteria.

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

Tests that measure this biomarker

These assays report EGFR (HER1) as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
cobas EGFR Mutation Test v2
Roche Molecular Systems, Inc.
Method
PCR
Specimen
Tissue (FFPE)

Reports EGFR (HER1) as part of its biomarker panel.

12 approvalsView test profile →
Test
Dako EGFR pharmDx Kit
Dako North America, Inc.
Method
IHC
Specimen
Tissue (FFPE)

Reports EGFR (HER1) as part of its biomarker panel.

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

Reports EGFR (HER1) as part of its biomarker panel.

7 approvalsView test profile →
Test
FoundationOne Liquid CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Whole blood

Reports EGFR (HER1) as part of its biomarker panel.

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

Reports EGFR (HER1) as part of its biomarker panel.

2 approvalsView test profile →
Test
MI Cancer Seek (MCS)
Caris Life Sciences
Method
NGS
Specimen
Tissue (FFPE)

Reports EGFR (HER1) as part of its biomarker panel.

6 approvalsView test profile →
Test
ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
Pillar Biosciences, Inc.
Method
NGS
Specimen
Tissue (FFPE)

Reports EGFR (HER1) as part of its biomarker panel.

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

Reports EGFR (HER1) as part of its biomarker panel.

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

Reports EGFR (HER1) as part of its biomarker panel.

2 approvalsView test profile →
Test
therascreen EGFR RGQ PCR Kit
Qiagen Manchester, Ltd.
Method
PCR
Specimen
Tissue (FFPE)

Reports EGFR (HER1) as part of its biomarker panel.

4 approvalsView test profile →
This view is scoped to EGFR (HER1). You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.