MSI-High
Biomarker
Microsatellite instability-high status reflects deficient DNA mismatch repair. MSI-High tumors are eligible for immune checkpoint inhibitor therapies across tumor types.
Approvals
3
Indications
1
Therapies
2
Mapped tests
2
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 MSI-High is defined directly in the indication labeling.
No indication-specific approvals are currently mapped for this biomarker.
Tests that measure this biomarker
These assays report MSI-High as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.
Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)
Reports MSI-High as part of its biomarker panel.
1 approvalView test profile →
Test
MI Cancer Seek (MCS)
Caris Life Sciences
Method
NGS
Specimen
Tissue (FFPE)
Reports MSI-High as part of its biomarker panel.
2 approvalsView test profile →