Gene
ALK
ALK is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (12), Assay-provider ledger (142), Actionable biomarkers (39), and 7 more evidence types, each linked to its source.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
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 ALK. 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: 6 with a planned future start and 13 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 100 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 223 of 8,738 | 2.55% | not measured | |
| 2025 | 241 of 8,875 | 2.72% | not measured | |
| 2024 | 233 of 8,597 | 2.71% | not measured | |
| 2023 | 217 of 8,275 | 2.62% | 156 of 11,460 | 1.36% |
| 2022 | 209 of 8,285 | 2.52% | 169 of 13,598 | 1.24% |
| 2021 | 216 of 8,692 | 2.49% | 183 of 15,045 | 1.22% |
| 2020 | 208 of 7,640 | 2.72% | 135 of 14,459 | 0.93% |
| 2019 | 195 of 7,300 | 2.67% | 119 of 12,159 | 0.98% |
| 2018 | 172 of 6,927 | 2.48% | 123 of 11,854 | 1.04% |
| 2017 | 148 of 6,558 | 2.26% | 109 of 11,595 | 0.94% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (12)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| Vysis ALK Break Apart FISH Probe Kit | ALK | Abbott Molecular Inc. | Non-Small Cell Lung Cancer (NSCLC) | 2025-08-05 |
| FoundationOne CDx | ALK | Foundation Medicine Inc. | Non-Small Cell Lung Cancer (NSCLC) | 2021-06-30 |
| Ventana ALK (D5F3) CDx Assay | ALK | Ventana Medical Systems, Inc. | Non-Small Cell Lung Cancer (NSCLC) | 2021-03-03 |
| FoundationOne Liquid CDx | ALK | Foundation Medicine, Inc. | Non-Small Cell Lung Cancer (NSCLC) | 2020-10-26 |
| Vysis ALK Break Apart FISH Probe Kit | ALK | Abbott Molecular Inc. | Non-Small Cell Lung Cancer (NSCLC) | 2020-05-22 |
Showing 5 of 12 companion diagnostic entries.
Assay-provider ledger (142)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| Foundation Medicine | Diagnostic provider | Clinical validationAnalytical validation | 9 | August 01, 2026 +2 undated |
| Olympus Corporation of Americas | Reagent supplier | Clinical validationAnalytical validation | 1 | August 01, 2026 |
| THERMO FISHER SCIENTIFIC (Click-iT EdU kit, TaqMan Low-Density Array reagents, ExpressionSuite/DataAssist software) | Reagent supplier | Clinical validationAnalytical validation | 10 | August 01, 2026 |
| University of Pittsburgh Medical Center (UPMC) Molecular & Genomics Pathology (MGP) laboratory | Not a company | Clinical validationAnalytical validation | 1 | August 01, 2026 |
| ROCHE | Context dependent | Clinical validationAnalytical validation | 8 | March 01, 2026 +1 undated |
Showing 5 of 142 assay-provider companies.
Actionable biomarkers (39)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| ALK (F856S,A348D) | Crizotinib | response-associated | acute myeloid leukemia | Cancer Genome Interpreter |
| ALK fusion | Alk Inhibitors | response-associated | colorectal adenocarcinoma | Cancer Genome Interpreter |
| ALK fusion | Entrictinib | response-associated | colorectal adenocarcinoma | Cancer Genome Interpreter |
| ALK fusion | Ceritinib | response-associated | colorectal adenocarcinoma | Cancer Genome Interpreter |
| ALK fusion | Crizotinib | response-associated | glioblastoma multiforme | Cancer Genome Interpreter |
Showing 5 of 39 actionable-biomarker assertions.
Trial mentions (2,561)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT05132257 | Trial biospecimen (AACT) |
| NCT03759327 | Trial biospecimen (AACT) |
| NCT04197076 | Trial biospecimen (AACT) |
| NCT01662635 | Trial biospecimen (AACT) |
| NCT05721950 | Trial biospecimen (AACT) |
Showing 5 of 2,561 trial mentions.
Target-disease associations (728)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| 46,XX gonadal dysgenesis | endocrine system disease | Mouse knockout (IMPC) |
| 46,XX testicular disorder of sex development | endocrine system disease | Mouse knockout (IMPC) |
| 46,XY complete gonadal dysgenesis | cardiovascular disease | Mouse knockout (IMPC) |
| 46,XY disorder of sex development due to 17-beta-hydroxysteroid dehydrogenase 3 deficiency | endocrine system disease | Mouse knockout (IMPC) |
| 46,XY disorder of sex development due to isolated 17,20 lyase deficiency | cancer or benign tumor | Mouse knockout (IMPC) |
Showing 5 of 728 associations.
Vendor sourcing (7,892)
Shown in this order: alphabetical by organization.
| Organization | Role | Tier | Evidence | Citation |
|---|---|---|---|---|
| 150th Hospital of PLA | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Diagnosed as stage Ⅳ naive EGFR wild-type lung adenocarcinoma by image, tissue and/or cytology; or relapse after operation (if the patient received adj... | View trial NCT02621333 |
| 150th Hospital of PLA | Trial collaborator | Mentioned in trial textTrial free-text mention | ALK | View trial NCT02621333 |
| 3D Medicines, Inc. (China) | Trial sponsor | Named in trial exclusion criteriaTrial eligibility criteria | : 1. Tumor histologically or cytologically confirmed or combined with neuroendocrine carcinoma components, or sarcomatous/sarcomatoid lesions, or adenosquam... | View trial NCT06123754 |
| 3D Medicines, Inc. (China) | Trial sponsor | Mentioned in trial textTrial free-text mention | ALK | View trial NCT06123754 |
| 7 Hills Pharma, LLC | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | 1. Adult patients (age 18 or older) 2. Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors... | View trial NCT06362369 |
Showing 5 of 7,892 sourcing records.
Trial-cited literature (1,498)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Adjuvant Durvalumab in Completely Resected Early-Stage Non-Small Cell Lung Cancer. | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 2026 | 8 |
| Lorlatinib in Tyrosine Kinase Inhibitor-Naive Advanced ROS1-Positive Non-Small Cell Lung Cancer: A Phase 2 Nonrandomized Clinical Trial. | JAMA oncology | 2026 | 4 |
| Improving aerobic capacity in patients with advanced non-small cell lung cancer: study protocol of the 3-armed randomized controlled BREATH trial. | Trials | 2026 | 0 |
| Preclinical characterization and first-in-human, phase I trial of the novel ALK inhibitor dirozalkib in advanced non-small cell lung cancer. | European journal of cancer (Oxford, England : 1990) | 2026 | 0 |
| Precision Medicine Program in Chinese Pediatric Patients With Sarcoma. | JCO precision oncology | 2026 | 0 |
Showing 5 of 1,498 papers.
Protein variant mentions (100)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A1046V | 1 | 2014 | PMID 24440717 |
| p.A1601T | 1 | 2015 | PMID 25741868 |
| p.A371T | 2 | 2015 | PMID 25741868, PMID 26580448 |
| p.C426R | 1 | 2021 | PMID 33247178 |
| p.D1091N | 3 | 2008 to 2021 | PMID 34885651, PMID 22072639, PMID 18724359 |
Showing 5 of 100 variants.
Literature-extracted relations (587)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| Crizotinib | Chemical | negative_correlate |
Real-world treatment patterns and subsequent treatment effectiveness following frontline brigatinib in the ALTA-1L trial. | 2025 |
| Crizotinib | Chemical | negative_correlate |
Successful and On-going Long-Term Disease Control (>24 Months) with Gilteritinib in an <i>ALK+</i> NSCLC Patient with Brain Metastasis Who Has Progressed on Multiple ALK TKIs. A Case Report and Review of Literature on Gilteritnib. | 2025 |
| Crizotinib | Chemical | negative_correlate |
First-Line Lorlatinib Versus Crizotinib in Asian Patients With Advanced ALK-Positive NSCLC: Five-Year Outcomes From the CROWN Study. | 2025 |
| Crizotinib | Chemical | negative_correlate |
Updated Efficacy and Safety of Lorlatinib in a Phase 2 Study in Chinese Patients With Previously Treated Advanced ALK-Positive Non-small Cell Lung Cancer. | 2024 |
| BEVACIZUMAB | Chemical | negative_correlate |
Safety and Patient-Reported outcomes of atezolizumab plus chemotherapy with or without bevacizumab in stage IIIB/IV non-squamous non-small cell lung cancer with EGFR mutation, ALK rearrangement or ROS1 fusion progressing after targeted therapies (GFPC 06-2018 study). | 2024 |
Showing 5 of 587 relation assertions.
Organizations publishing (958)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Hospital | 100 | 2011 to 2025 |
| Mass General Brigham | Hospital | 80 | 2009 to 2025 |
| Dana-Farber Cancer Institute | Other | 72 | 2010 to 2025 |
| The University of Texas System | Academic | 61 | 2009 to 2023 |
| Harvard Medical School | Academic | 48 | 2011 to 2025 |
Showing 5 of 958 organizations.
Where ALK 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
- medical procedure
- 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
615 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects and human sample screening reference.