KMT2A
Biomarker
KMT2A is a biomarker used in companion diagnostic testing.
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 KMT2A is defined directly in the indication labeling.
| Indication | Biomarker criteria | Therapies |
|---|---|---|
Acute Leukemia Heme · Leukemia |
|
Tumor-agnostic approvals
Approvals defined at the solid tumor level where KMT2A is part of the eligibility criteria.
No tumor-agnostic approvals are currently mapped for this biomarker.
Tests that measure this biomarker
These assays report KMT2A as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.
Test
KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
Cytocell Limited
Method
FISH
Specimen
Not specified
Reports KMT2A as part of its biomarker panel.
1 approvalView test profile →