Gene
KIT
KIT 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 (116), Actionable biomarkers (47), and 8 more evidence types, each linked to its source.
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Rows recorded per section (log scale)
3 more sections with rows · 1 section measured, none recorded
FDA companion diagnostic
An FDA-cleared or approved companion diagnostic names this biomarker.
Evidence over time
Share of that year: what fraction of the trials and papers our biomarker dictionary matched in a year mention KIT. 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: 33 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 10 of 8,738 | 0.11% | not measured | |
| 2025 | 16 of 8,875 | 0.18% | not measured | |
| 2024 | 13 of 8,597 | 0.15% | not measured | |
| 2023 | 14 of 8,275 | 0.17% | 104 of 11,460 | 0.91% |
| 2022 | 14 of 8,285 | 0.17% | 110 of 13,598 | 0.81% |
| 2021 | 10 of 8,692 | 0.12% | 131 of 15,045 | 0.87% |
| 2020 | 13 of 7,640 | 0.17% | 120 of 14,459 | 0.83% |
| 2019 | 8 of 7,300 | 0.11% | 131 of 12,159 | 1.08% |
| 2018 | 9 of 6,927 | 0.13% | 106 of 11,854 | 0.89% |
| 2017 | 8 of 6,558 | 0.12% | 126 of 11,595 | 1.09% |
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 |
|---|---|---|---|---|
| KIT D816V Assay | KIT | ARUP Laboratories, Inc. | Aggressive Systemic Mastocytosis | 2015-12-18 |
Assay-provider ledger (116)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| GenomeMe | Reagent supplier | Clinical validation | 1 | August 06, 2026 |
| Invitrogen | Reagent supplier | Clinical validationAnalytical validation | 3 | January 30, 2026 +1 undated |
| Ventana Medical Systems | Unclassified | Clinical validation | 1 | January 30, 2026 |
| MD Anderson (84-1 anti-vimentin antibody, MD Anderson) | Not a company | No clinical or analytical validation recorded for this pair | 1 | July 29, 2025 |
| Peter MacCallum Cancer Centre | Not a company | Clinical validation | 1 | July 01, 2025 |
Showing 5 of 116 assay-provider companies.
Actionable biomarkers (47)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| KIT (D816) | Imatinib | responsive | Chronic Eosinophilic Leukemia, Not Otherwise Specified | Cancer Genome Interpreter |
| KIT (D816) | Imatinib | responsive | Hypereosinophilic syndrome | Cancer Genome Interpreter |
| KIT (D816) | Imatinib | responsive | Myelodysplastic/Myeloproliferative Neoplasm | Cancer Genome Interpreter |
| KIT inframe deletion (577-579) | Sorafenib | response-associated | Thymic Carcinoma | Cancer Genome Interpreter |
| KIT (Y553N) | SUNITINIB | response-associated | Thymic Carcinoma | Cancer Genome Interpreter |
Showing 5 of 47 actionable-biomarker assertions.
Trial mentions (225)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT07562542 | Trial biospecimen (AACT) |
| NCT03092128 | Trial biospecimen (AACT) |
| NCT03602092 | Trial biospecimen (AACT) |
| NCT00676624 | Trial biospecimen (AACT) |
| NCT06630234 | Trial eligibility (AACT) |
Showing 5 of 225 trial mentions.
Target-disease associations (1,897)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| 22q11.2 deletion syndrome | cardiovascular disease | Mouse knockout (IMPC) |
| 3-phosphoglycerate dehydrogenase deficiency, infantile/juvenile form | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 46 XX gonadal dysgenesis | endocrine system disease | Mouse knockout (IMPC) |
| 46,XX gonadal dysgenesis | endocrine system disease | Mouse knockout (IMPC) |
| 46,XX ovotesticular disorder of sex development | endocrine system disease | Mouse knockout (IMPC) |
Showing 5 of 1,897 associations.
Vendor sourcing (778)
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 | The variant is not observed in the gnomAD v2.1.1 dataset. Predicted Consequence/Location: Missense variant In silico tool predictions suggest damaging effect... | View ClinVar record SCV005904578.1 |
| ARIAD Pharmaceuticals (United States) | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Male or female participants \>=18 years old. 2. GIST with failure of prior TKI therapy defined as: 1. Histologically confirmed metastatic and/or un... | View trial NCT01874665 |
| ARIAD Pharmaceuticals (United States) | Trial sponsor | Mentioned in trial textTrial free-text mention | KIT | View trial NCT01874665 |
| ARUP Laboratories (United States) | Diagnostics manufacturer | FDA-authorized companion diagnosticFDA companion diagnostic authorization | D816V | View FDA device record |
| ARUP Laboratories (United States) | Testing lab / CRO (runs the assay) | Clinical-testing interpretation submitted (ClinVar)ClinVar clinical-testing submission | The KIT c.503C>T; p.Ala168Val variant (rs149092990), to our knowledge, is not reported in the medical literature associated with familial gastrointestinal st... | View ClinVar record SCV004563212.1 |
Showing 5 of 778 sourcing records.
Trial-cited literature (1,814)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Phase 3 study of intensive chemotherapy with or without dasatinib in core-binding factor acute myeloid leukemia. | Blood | 2026 | 3 |
| Efficacy and safety of avapritinib in advanced systemic mastocytosis: 4-year follow-up of the PATHFINDER study. | Blood advances | 2026 | 0 |
| Evidence for dysbiosis in the gut microbiome of patients with systemic mastocytosis. | The journal of allergy and clinical immunology. Global | 2026 | 0 |
| Cancer of the ovary, fallopian tube, and peritoneum: 2025 update. | International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics | 2025 | 27 |
| Irradiation- and busulfan-free stem cell transplantation in Fanconi anemia using an anti-CD117 antibody: a phase 1b trial. | Nature medicine | 2025 | 12 |
Showing 5 of 1,814 papers.
Protein variant mentions (85)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A268P | 1 | 2016 | PMID 27659017 |
| p.A280V | 2 | 2012 to 2019 | PMID 30675060, PMID 22703879 |
| p.A404T | 1 | 2015 | PMID 25741868 |
| p.A829P | 3 | 2011 to 2017 | PMID 28334439, PMID 25239608, PMID 21642685 |
| p.C2255T | 1 | 2010 | PMID 20233444 |
Showing 5 of 85 variants.
Human sample screening reference (3)
Shown in this order: alphabetical by variant.
| Variant | GDC project | Disease / site | Affected cases | Profiled cases | Observed frequency | 95% interval |
|---|---|---|---|---|---|---|
| p.M552L | TCGA-LUSC | Adenomas and Adenocarcinomas; Squamous Cell Neoplasms; Bronchus and lung | 1 | 504 | 0.20% | 0.04% to 1.12% |
| p.V559A | CCDI-MCI | Cystic, Mucinous and Serous Neoplasms; Granular Cell Tumors and Alveolar Soft Part Sarcomas; Specialized Gonadal Neoplasms; Neoplasms, NOS; Adenomas and Adenocarcinomas; Gliomas; Meningiomas; Acinar Cell Neoplasms; Odontogenic Tumors; Soft Tissue Tumors and Sarcomas, NOS; Nevi and Melanomas; Malignant Lymphomas, NOS or Diffuse; Epithelial Neoplasms, NOS; Thymic Epithelial Neoplasms; Other and unspecified parts of mouth; Rectosigmoid junction; Thyroid gland; Connective, subcutaneous and other soft tissues; Peripheral nerves and autonomic nervous system; Other endocrine glands and related structures; Retroperitoneum and peritoneum; Vagina; Other and ill-defined digestive organs; Pancreas; Renal pelvis; Bladder; Nasal cavity and middle ear; Meninges; Adrenal gland; Bones, joints and articular cartilage of limbs; Bones, joints and articular cartilage of other and unspecified sites; Breast; Skin; Thymus; Esophagus; Other and ill-defined sites in lip, oral cavity and pharynx; Larynx; Other and unspecified urinary organs; Brain; Testis; Heart, mediastinum, and pleura; Rectum; Nasopharynx; Palate; Prostate gland; Base of tongue; Accessory sinuses; Other and unspecified female genital organs; Lip; Spinal cord, cranial nerves, and other parts of central nervous system; Colon; Oropharynx; Other and ill-defined sites; Unknown; Other and ill-defined sites within respiratory system and intrathoracic organs; Other and unspecified male genital organs; Cervix uteri; Bronchus and lung; Eye and adnexa; Ovary; Small intestine; Lymph nodes; Stomach | 1 | 3,033 | 0.03% | 0.01% to 0.19% |
| p.V559A | TCGA-SKCM | Nevi and Melanomas; Skin; Connective, subcutaneous and other soft tissues; Lymph nodes; Nasal cavity and middle ear; Vulva; Breast; Bones, joints and articular cartilage of other and unspecified sites; Retroperitoneum and peritoneum; Vagina; Colon; Adrenal gland; Corpus uteri; Other and ill-defined sites; Liver and intrahepatic bile ducts; Anus and anal canal; Spinal cord, cranial nerves, and other parts of central nervous system; Small intestine; Bronchus and lung; Brain; Parotid gland | 3 | 470 | 0.64% | 0.22% to 1.86% |
Literature-extracted relations (554)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| SUNITINIB | Chemical | associate |
Phase II Study of Sunitinib in Tumors With <i>c-KIT</i> Mutations: Results From the NCI MATCH ECOG-ACRIN Trial (EAY131) Subprotocol V. | 2024 |
| Imatinib | Chemical | negative_correlate |
The INSIGHT study: a randomized, Phase III study of ripretinib versus sunitinib for advanced gastrointestinal stromal tumor with <i>KIT</i> exon 11 + 17/18 mutations. | 2024 |
| SUNITINIB | Chemical | associate |
The INSIGHT study: a randomized, Phase III study of ripretinib versus sunitinib for advanced gastrointestinal stromal tumor with <i>KIT</i> exon 11 + 17/18 mutations. | 2024 |
| ADENOSINE TRIPHOSPHATE | Chemical | associate |
Ripretinib versus sunitinib in gastrointestinal stromal tumor: ctDNA biomarker analysis of the phase 3 INTRIGUE trial. | 2024 |
| Imatinib | Chemical | negative_correlate |
Ripretinib versus sunitinib in gastrointestinal stromal tumor: ctDNA biomarker analysis of the phase 3 INTRIGUE trial. | 2024 |
Showing 5 of 554 relation assertions.
Organizations publishing (875)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Dana-Farber Cancer Institute | Other | 103 | 2002 to 2026 |
| Memorial Sloan Kettering Cancer Center | Hospital | 102 | 2002 to 2025 |
| Government of the United States of America | Government | 84 | 1995 to 2026 |
| The University of Texas System | Academic | 74 | 2008 to 2026 |
| Mass General Brigham | Hospital | 61 | 2000 to 2024 |
Showing 5 of 875 organizations.
Where KIT appears
- animal disease
- biological_process
- cancer or benign tumor
- cardiovascular disease
- disorder of ear
- 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
- pregnancy or perinatal disease
- reproductive system or breast disease
- respiratory or thoracic disease
- urinary system disease
1,608 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.