Gene
KMT2A
KMT2A is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (1), Assay-provider ledger (9), Actionable biomarkers (6), and 7 more evidence types, each linked to its source.
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Rows recorded per section (log scale)
2 more sections with rows · 2 sections measured, none recorded
FDA companion diagnostic
Evidence over time
Share of that year: what fraction of the trials and papers our biomarker dictionary matched in a year mention KMT2A. The denominator is documents that mention any gene, not every registered document, so improving the matcher moves both halves and never rewrites history. Gene named in free-text trial records. A mention, not a validated biomarker. Actionable-biomarker and target-disease-association evidence carries no date in our sources, so it is not on this chart. Publication mentions cover only papers cited by a registered clinical trial, not all of PubMed.
Trial mentions: plotted from 1990 to 2026, the years our matched corpus covers. Not plotted: 1 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 22 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 23 of 8,738 | 0.26% | not measured | |
| 2025 | 21 of 8,875 | 0.24% | not measured | |
| 2024 | 21 of 8,597 | 0.24% | not measured | |
| 2023 | 12 of 8,275 | 0.15% | 33 of 11,460 | 0.29% |
| 2022 | 13 of 8,285 | 0.16% | 41 of 13,598 | 0.30% |
| 2021 | 12 of 8,692 | 0.14% | 43 of 15,045 | 0.29% |
| 2020 | 10 of 7,640 | 0.13% | 36 of 14,459 | 0.25% |
| 2019 | 11 of 7,300 | 0.15% | 30 of 12,159 | 0.25% |
| 2018 | 12 of 6,927 | 0.17% | 26 of 11,854 | 0.22% |
| 2017 | 11 of 6,558 | 0.17% | 32 of 11,595 | 0.28% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (1)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | KMT2A | Cytocell Limited | Acute Leukemia | 2025-09-19 |
Assay-provider ledger (9)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| Cleveland Clinic | Not a company | Clinical validation | 1 | June 01, 2026 |
| Gene seqPrime | Diagnostic provider | No clinical or analytical validation recorded for this pair | 1 | September 30, 2021 |
| Invitrogen | Reagent supplier | Analytical validation | 1 | January 30, 2017 |
| Promega | Reagent supplier | Analytical validation | 1 | January 30, 2017 |
| QIAGEN | Reagent supplier | Analytical validation | 1 | January 30, 2017 |
Showing 5 of 9 assay-provider companies.
Actionable biomarkers (6)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| MLL fusion | Epz-5676 | response-associated | acute lymphoblastic leukemia | Cancer Genome Interpreter |
| MLL fusion | Belinostat | response-associated | acute myeloid leukemia | Cancer Genome Interpreter |
| MLL fusion | Bet Inhibitors | response-associated | acute myeloid leukemia | Cancer Genome Interpreter |
| MLL fusion | Daunorubicin | response-associated | acute myeloid leukemia | Cancer Genome Interpreter |
| MLL fusion | Epz-5676 | response-associated | acute myeloid leukemia | Cancer Genome Interpreter |
Showing 5 of 6 actionable-biomarker assertions.
Trial mentions (251)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT06229912 | Trial eligibility (AACT) |
| NCT07356154 | Trial eligibility (AACT) |
| NCT05327894 | Trial eligibility (AACT) |
| NCT02497404 | Trial eligibility (AACT) |
| NCT00222612 | Trial eligibility (AACT) |
Showing 5 of 251 trial mentions.
Target-disease associations (731)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| 3-M syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 5-methyluridine (ribothymidine) measurement | measurement | GWAS credible sets |
| Acromesomelic dysplasia, Maroteaux type | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| Acropectorovertebral dysplasia | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| Acute Leukemia | cancer or benign tumor | Literature (Europe PMC) |
Showing 5 of 731 associations.
Vendor sourcing (964)
Shown in this order: alphabetical by organization.
| Organization | Role | Tier | Evidence | Citation |
|---|---|---|---|---|
| 3billion, Inc. (South Korea) | Testing lab / CRO (runs the assay) | Clinical-testing interpretation submitted (ClinVar)ClinVar clinical-testing submission | Stop-gained (nonsense): predicted to result in a loss or disruption of normal protein function through nonsense-mediated decay (NMD) or protein truncation. M... | View ClinVar record SCV002012176.1 |
| AVEO Oncology (United States) | Trial collaborator | Named in trial exclusion criteriaTrial eligibility criteria | (EC): * Acute promyelocytic leukemia (APL) * Clinically active CNS involvement by AML. A patient may be considered eligible if CNS leukemia is showing respo... | View trial NCT03013998 |
| AVEO Oncology (United States) | Trial collaborator | Mentioned in trial textTrial free-text mention | KMT2A | View trial NCT03013998 |
| Aamu Pediatric Cancer Foundation | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | : * Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours... | View trial NCT04307576 |
| Aamu Pediatric Cancer Foundation | Trial collaborator | Mentioned in trial textTrial free-text mention | KMT2A | View trial NCT04307576 |
Showing 5 of 964 sourcing records.
Trial-cited literature (473)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Menin inhibition enhances graft-versus-leukemia effects by T-cell activation and endogenous retrovirus induction in AML. | Blood | 2026 | 5 |
| Homeodomain-driven oncogenic diversion to a TCRγδ phenotype in T-cell Acute Lymphoblastic Leukemia. | Blood | 2026 | 1 |
| Impact of Mutational Landscape and Burden on RBC Transfusion Response in Patients With Lower-Risk Myelodysplastic Syndromes (LR-MDS) in the COMMANDS Study. | American journal of hematology | 2026 | 0 |
| Menin Inhibition With Revumenib for <i>KMT2A</i>-Rearranged Relapsed or Refractory Acute Leukemia (AUGMENT-101). | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 2025 | 201 |
| Menin inhibition with revumenib for NPM1-mutated relapsed or refractory acute myeloid leukemia: the AUGMENT-101 study. | Blood | 2025 | 60 |
Showing 5 of 473 papers.
Protein variant mentions (74)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A1032S | 1 | 2015 | PMID 25741868 |
| p.A1877V | 1 | 2015 | PMID 25741868 |
| p.A3492T | 1 | 2015 | PMID 25741868 |
| p.A53V | 1 | 2015 | PMID 25741868 |
| p.C1189R | 1 | 2015 | PMID 25741868 |
Showing 5 of 74 variants.
Literature-extracted relations (91)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| AZACITIDINE (VIDAZA) | Chemical | negative_correlate |
Azacitidine as epigenetic priming for chemotherapy is safe and well-tolerated in infants with newly diagnosed <i>KMT2A</i>-rearranged acute lymphoblastic leukemia: Children's Oncology Group trial AALL15P1. | 2024 |
| Gemtuzumab | Chemical | negative_correlate |
Gemtuzumab Ozogamicin Improves Event-Free Survival and Reduces Relapse in Pediatric <i>KMT2A</i>-Rearranged AML: Results From the Phase III Children's Oncology Group Trial AAML0531. | 2021 |
| Vincristine | Chemical | positive_correlate |
Combinatorial efficacy of entospletinib and chemotherapy in patient-derived xenograft models of infant acute lymphoblastic leukemia. | 2021 |
| CYTARABINE | Chemical | associate |
A novel regimen for relapsed/refractory adult acute myeloid leukemia using a <i>KMT2A</i> partial tandem duplication targeted therapy: results of phase 1 study NCI 8485. | 2018 |
| Decitabine | Chemical | associate |
A novel regimen for relapsed/refractory adult acute myeloid leukemia using a <i>KMT2A</i> partial tandem duplication targeted therapy: results of phase 1 study NCI 8485. | 2018 |
Showing 5 of 91 relation assertions.
Organizations publishing (464)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Novant Health | Hospital | 50 | 1998 to 2024 |
| Dana-Farber Cancer Institute | Other | 30 | 2010 to 2025 |
| Memorial Sloan Kettering Cancer Center | Hospital | 28 | 2012 to 2025 |
| The University of Texas System | Academic | 27 | 2010 to 2026 |
| Government of the United States of America | Government | 21 | 1999 to 2023 |
Showing 5 of 464 organizations.
Where KMT2A appears
- biological_process
- cancer or benign tumor
- cardiovascular disease
- disorder of visual system
- endocrine system disease
- gastrointestinal disease
- genetic, familial or congenital disease
- hematologic disease
- immune system disease
- infectious disease
- injury, poisoning or other complication
- integumentary system disease
- measurement
- musculoskeletal or connective tissue disease
- nervous system disease
- nutritional or metabolic disease
- phenotype
- reproductive system or breast disease
- respiratory or thoracic disease
- urinary system disease
672 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects and human sample screening reference.