ESR1

Biomarker

ESR1 encodes the estrogen receptor and is central to hormone-driven breast cancer biology. Acquired mutations can confer resistance to endocrine therapies and guide treatment decisions.

Approvals
1
Indications
1
Therapies
1
Mapped tests
1

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 ESR1 is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Breast Cancer
Solid Tumor · Breast
  • ESR1 missense mutations between codons 310 and 547
Tumor-agnostic approvals

Approvals defined at the solid tumor level where ESR1 is part of the eligibility criteria.

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

Tests that measure this biomarker

These assays report ESR1 as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
Guardant360 CDx
Guardant Health, Inc.
Method
NGS
Specimen
Plasma

Reports ESR1 as part of its biomarker panel.

This view is scoped to ESR1. You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.