Gene
FGFR3
FGFR3 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 (60), Actionable biomarkers (8), 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
Evidence over time
Share of that year: what fraction of the trials and papers our biomarker dictionary matched in a year mention FGFR3. 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: 12 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 1 of 8,738 | 0.01% | not measured | |
| 2025 | 10 of 8,875 | 0.11% | not measured | |
| 2024 | 2 of 8,597 | 0.02% | not measured | |
| 2023 | 5 of 8,275 | 0.06% | 29 of 11,460 | 0.25% |
| 2022 | 5 of 8,285 | 0.06% | 33 of 13,598 | 0.24% |
| 2021 | 4 of 8,692 | 0.05% | 36 of 15,045 | 0.24% |
| 2020 | 7 of 7,640 | 0.09% | 31 of 14,459 | 0.21% |
| 2019 | 2 of 7,300 | 0.03% | 30 of 12,159 | 0.25% |
| 2018 | 2 of 6,927 | 0.03% | 30 of 11,854 | 0.25% |
| 2017 | 3 of 6,558 | 0.05% | 29 of 11,595 | 0.25% |
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 |
|---|---|---|---|---|
| therascreen FGFR RGQ RT-PCR Kit | FGFR3 | QIAGEN Manchester Ltd. | Urothelial Cancer | 2019-04-12 |
Assay-provider ledger (60)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| U-Monitor, Porto, Portugal | Diagnostic provider | Clinical validation | 2 | July 01, 2026 |
| STRATIFYER Molecular Pathology GmbH | Diagnostic provider | Clinical validation | 2 | June 01, 2026 |
| U Monitor Lda | Diagnostic provider | Clinical validation | 2 | June 01, 2026 |
| QIAGEN | Reagent supplier | Clinical validationAnalytical validation | 5 | January 01, 2026 |
| THERMO FISHER SCIENTIFIC (Click-iT EdU kit, TaqMan Low-Density Array reagents, ExpressionSuite/DataAssist software) | Reagent supplier | Clinical validationAnalytical validation | 7 | January 01, 2026 |
Showing 5 of 60 assay-provider companies.
Actionable biomarkers (8)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| FGFR3 fusion | Fgfr Inhibitors | response-associated | glioma | Cancer Genome Interpreter |
| FGFR3 (S249C,G691R) | Fgfr Inhibitors | response-associated | lung adenocarcinoma | Cancer Genome Interpreter |
| FGFR3 (K650) | Bortezomib | response-associated | multiple myeloma | Cancer Genome Interpreter |
| FGFR3 (K650,Y373C) | Fgfr Inhibitors | response-associated | multiple myeloma | Cancer Genome Interpreter |
| FGFR3 (V555M) | Fgfr Inhibitors | responsive | multiple myeloma | Cancer Genome Interpreter |
Showing 5 of 8 actionable-biomarker assertions.
Trial mentions (63)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT05966350 | Trial biospecimen (AACT) |
| NCT02546661 | Trial eligibility (AACT) |
| NCT06524544 | Trial eligibility (AACT) |
| NCT04601857 | Trial eligibility (AACT) |
| NCT02272998 | Trial eligibility (AACT) |
Showing 5 of 63 trial mentions.
Target-disease associations (1,627)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| 17p13.3 microduplication syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 17q21.31 microduplication syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 20p12.3 microdeletion syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 22q11.2 microduplication syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 2q33.1 microdeletion syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
Showing 5 of 1,627 associations.
Vendor sourcing (204)
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 v4.1.0 dataset. Predicted Consequence/Location: Missense variant. Missense changes are a common disease-causing mec... | View ClinVar record SCV002012278.2 |
| AB Science (France) | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | : * Confirmed multiple myeloma with a t (4; 14) translocation by FISH and PCR, expressing or not expressing FGFR3 identified by FACS * Patients with Multipl... | View trial NCT00866138 |
| AB Science (France) | Trial sponsor | Mentioned in trial textTrial free-text mention | FGFR3 | View trial NCT00866138 |
| AMS Advanced Medical Services GmbH | Trial collaborator | Mentioned in trial textTrial free-text mention | FGFR3 | View trial NCT04294277 |
| ARUP Laboratories (United States) | Testing lab / CRO (runs the assay) | Clinical-testing interpretation submitted (ClinVar)ClinVar clinical-testing submission | The FGFR3 c.1118A>G; p.Tyr373Cys variant (rs121913485) is reported in the literature in multiple individuals affected with thanatophoric dwarfism (Brodie 199... | View ClinVar record SCV000603706.8 |
Showing 5 of 204 sourcing records.
Trial-cited literature (361)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Once-Weekly Navepegritide in Children With Achondroplasia: The APPROACH Randomized Clinical Trial. | JAMA pediatrics | 2026 | 9 |
| Pre-treatment metastatic biopsy: a step towards precision oncology for urothelial cancer. | Nature reviews. Urology | 2025 | 5 |
| A phase II, multicenter, single-arm study of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring FGFR alterations. | The oncologist | 2025 | 3 |
| Pemigatinib in previously treated solid tumors with activating FGFR1-FGFR3 alterations: phase 2 FIGHT-207 basket trial. | Nature medicine | 2024 | 62 |
| Genomic landscape of patients with germline RUNX1 variants and familial platelet disorder with myeloid malignancy. | Blood advances | 2024 | 33 |
Showing 5 of 361 papers.
Protein variant mentions (75)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A18T | 1 | 2015 | PMID 26674132 |
| p.A265T | 1 | 2019 | PMID 30650148 |
| p.A334T | 1 | 2016 | PMID 26910679 |
| p.A47W | 1 | 2016 | PMID 27197067 |
| p.A665S | 1 | 2015 | PMID 25741868 |
Showing 5 of 75 variants.
Human sample screening reference (2)
Shown in this order: alphabetical by variant.
| Variant | GDC project | Disease / site | Affected cases | Profiled cases | Observed frequency | 95% interval |
|---|---|---|---|---|---|---|
| p.G346E | 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.P358L | TCGA-BLCA | Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Squamous Cell Neoplasms; Transitional Cell Papillomas and Carcinomas; Bladder | 1 | 412 | 0.24% | 0.04% to 1.36% |
Literature-extracted relations (114)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| Achondroplasia | Disease | associate |
Once-Weekly Navepegritide in Children With Achondroplasia: The APPROACH Randomized Clinical Trial. | 2026 |
| Calcinosis Cutis | Disease | associate |
Pre-treatment metastatic biopsy: a step towards precision oncology for urothelial cancer. | 2025 |
| Small Fiber Neuropathy | Disease | associate |
Effectiveness of IVIG on Non-Length-Dependent Skin Biopsies in Small Fiber Neuropathy With Plexin D1, Trisulfated Heparin Disaccharide, and Fibroblast Growth Factor Receptor 3 Autoantibodies. | 2024 |
| Neoplasms | Disease | associate |
Pemigatinib in previously treated solid tumors with activating FGFR1-FGFR3 alterations: phase 2 FIGHT-207 basket trial. | 2024 |
| Neoplasms | Disease | associate |
Phase 1b Trial Evaluating Tolerability and Activity of Targeted Fibroblast Growth Factor Receptor Inhibition in Localized Upper Tract Urothelial Carcinoma. | 2024 |
Showing 5 of 114 relation assertions.
Organizations publishing (361)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Hospital | 25 | 2009 to 2024 |
| Dana-Farber Cancer Institute | Other | 19 | 2014 to 2022 |
| Harvard Medical School | Academic | 14 | 2012 to 2024 |
| The University of Texas System | Academic | 14 | 2012 to 2024 |
| Government of the United States of America | Government | 13 | 1996 to 2024 |
Showing 5 of 361 organizations.
Where FGFR3 appears
- 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
- medical procedure
- 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
1,389 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.