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KRAS

Biomarker

KRAS is a key signaling protein in the MAPK pathway. Historically considered undruggable, specific KRAS mutations are now actionable in select cancers.

Approvals
19
Indications
2
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 KRAS is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Colorectal Cancer (CRC)
Solid Tumor · Colorectal
  • wild-type (absence of mutations in exons 2, 3 and 4)
  • KRAS wild-type (absence of mutations in codons 12 and 13)
  • G12C
  • G12A, G12D, G12R, G12C, G12S, G12V, G13D
  • Mutations in codons 12 and 13 of KRAS gene
VECTIBIXERBITUXLUMAKRAS + VECTIBIXKRAZATI + ERBITUX
Non-Small Cell Lung Cancer (NSCLC)
Solid Tumor · Lung
  • G12C
KRAZATILUMAKRAS
Tumor-agnostic approvals

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

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

Tests that measure this biomarker

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

Test
Agilent Resolution ctDx FIRST assay
Resolution Bioscience
Method
NGS
Specimen
Plasma

Reports KRAS as part of its biomarker panel.

1 approvalView test profile →
Test
cobas KRAS Mutation Test
Roche Molecular Systems, Inc.
Method
PCR
Specimen
Tissue (FFPE)

Reports KRAS as part of its biomarker panel.

2 approvalsView test profile →
Test
CRCDx RAS Mutation Detection Assay Kit
EntroGen, Inc.
Method
PCR
Specimen
Tissue (FFPE)

Reports KRAS as part of its biomarker panel.

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

Reports KRAS as part of its biomarker panel.

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

Reports KRAS as part of its biomarker panel.

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

Reports KRAS as part of its biomarker panel.

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

Reports KRAS as part of its biomarker panel.

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

Reports KRAS as part of its biomarker panel.

7 approvalsView test profile →
Test
xT CDx
Tempus
Method
NGS
Specimen
Tissue (FFPE)

Reports KRAS as part of its biomarker panel.

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