Gene
ROS1
ROS1 is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (3), Assay-provider ledger (85), Actionable biomarkers (9), 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 ROS1. 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: 2 with a planned future start and 7 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 45 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 106 of 8,738 | 1.21% | not measured | |
| 2025 | 122 of 8,875 | 1.37% | not measured | |
| 2024 | 116 of 8,597 | 1.35% | not measured | |
| 2023 | 115 of 8,275 | 1.39% | 63 of 11,460 | 0.55% |
| 2022 | 97 of 8,285 | 1.17% | 70 of 13,598 | 0.51% |
| 2021 | 109 of 8,692 | 1.25% | 70 of 15,045 | 0.47% |
| 2020 | 86 of 7,640 | 1.13% | 47 of 14,459 | 0.33% |
| 2019 | 87 of 7,300 | 1.19% | 40 of 12,159 | 0.33% |
| 2018 | 69 of 6,927 | 1.00% | 34 of 11,854 | 0.29% |
| 2017 | 45 of 6,558 | 0.69% | 29 of 11,595 | 0.25% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (3)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| FoundationOne Liquid CDx | ROS1 | Foundation Medicine, Inc. | Non-Small Cell Lung Cancer (NSCLC) | 2022-12-22 |
| FoundationOne CDx | ROS1 | Foundation Medicine, Inc. | Non-Small Cell Lung Cancer (NSCLC) | 2022-06-07 |
| Oncomine Dx Target Test | ROS1 | Life Technologies Corporation | Non-Small Cell Lung Cancer (NSCLC) | 2017-06-22 |
Assay-provider ledger (85)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| AmoyDx | Diagnostic provider | Clinical validationAnalytical validation | 2 | December 08, 2025 |
| Horizon | Reagent supplier | Clinical validationAnalytical validation | 1 | December 08, 2025 |
| QIAGEN | Reagent supplier | Clinical validationAnalytical validation | 1 | December 08, 2025 |
| ROCHE | Context dependent | Clinical validationAnalytical validation | 2 | December 08, 2025 |
| SensID | Diagnostic provider | Clinical validationAnalytical validation | 1 | December 08, 2025 |
Showing 5 of 85 assay-provider companies.
Actionable biomarkers (9)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| ROS1 (G2032R) | CABOZANTINIB | response-associated | lung adenocarcinoma | Cancer Genome Interpreter |
| ROS1 (S1986Y,S1986F) | Lorlatinib | response-associated | lung adenocarcinoma | Cancer Genome Interpreter |
| ROS1 fusion | Crizotinib | response-associated | lung adenocarcinoma | Cancer Genome Interpreter |
| ROS1 fusion | Hsp90 Inhibitors | response-associated | lung adenocarcinoma | Cancer Genome Interpreter |
| ROS1 (S1986Y,S1986F) | Crizotinib | responsive | lung adenocarcinoma | Cancer Genome Interpreter |
Showing 5 of 9 actionable-biomarker assertions.
Trial mentions (1,014)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT04197076 | Trial biospecimen (AACT) |
| NCT03497624 | Trial biospecimen (AACT) |
| NCT06069570 | Trial eligibility (AACT) |
| NCT07082179 | Trial eligibility (AACT) |
| NCT07836777 | Trial eligibility (AACT) |
Showing 5 of 1,014 trial mentions.
Target-disease associations (440)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| 46,XX ovotesticular disorder of sex development | endocrine system 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 5-alpha-reductase 2 deficiency | endocrine system disease | Mouse knockout (IMPC) |
| 46,XY partial gonadal dysgenesis | endocrine system disease | Mouse knockout (IMPC) |
| Abnormal brain morphology | phenotype | Variant curation (ClinVar / EVA) |
Showing 5 of 440 associations.
Vendor sourcing (3,024)
Shown in this order: alphabetical by organization.
| Organization | Role | Tier | Evidence | Citation |
|---|---|---|---|---|
| 900th Hospital of PLA Joint Logistic Support Force | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Patients with pathologically confirmed NSCLC, meeting the following criteria based on the IASLC 9th Edition Lung Cancer TNM Staging System (Internation... | View trial NCT07093762 |
| 900th Hospital of PLA Joint Logistic Support Force | Trial collaborator | Mentioned in trial textTrial free-text mention | ROS1 | View trial NCT07093762 |
| ANRS, Emerging Infectious Diseases | Trial collaborator | Named in trial exclusion criteriaTrial eligibility criteria | : 1. Concurrent malignancies requiring active intervention 2. Active Infection 3. Patient with known EGFR activating tumor mutation or known ALK or ROS1 gen... | View trial NCT03304093 |
| ANRS, Emerging Infectious Diseases | Trial collaborator | Mentioned in trial textTrial free-text mention | ROS1 | View trial NCT03304093 |
| AP Biosciences Inc. | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Participants who have histologically or cytologically confirmed diagnosis of relapsed or refractory, locally unresectable advanced or metastatic NSCL... | View trial NCT05473156 |
Showing 5 of 3,024 sourcing records.
Trial-cited literature (475)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| 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 |
| Taletrectinib in <i>ROS1</i>+ Non-Small Cell Lung Cancer: TRUST. | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 2025 | 45 |
| Subcutaneous versus intravenous pembrolizumab, in combination with chemotherapy, for treatment of metastatic non-small-cell lung cancer: the phase III 3475A-D77 trial. | Annals of oncology : official journal of the European Society for Medical Oncology | 2025 | 34 |
Showing 5 of 475 papers.
Protein variant mentions (27)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A19M | 1 | 2020 | PMID 33095287 |
| p.A2100S | 1 | 2016 | PMID 27602761 |
| p.A21M | 1 | 2020 | PMID 33095287 |
| p.C11F | 1 | 2020 | PMID 33095287 |
| p.C13M | 1 | 2020 | PMID 33095287 |
Showing 5 of 27 variants.
Literature-extracted relations (148)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| Crizotinib | Chemical | negative_correlate |
Lorlatinib in Tyrosine Kinase Inhibitor-Naive Advanced ROS1-Positive Non-Small Cell Lung Cancer: A Phase 2 Nonrandomized Clinical Trial. | 2026 |
| Crizotinib | Chemical | negative_correlate |
Entrectinib versus crizotinib in Asian patients with ROS1-positive non-small cell lung cancer: A matching-adjusted indirect comparison. | 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 |
| Crizotinib | Chemical | negative_correlate |
Efficacy and safety of crizotinib in ALK-positive systemic anaplastic large-cell lymphoma in children, adolescents, and adult patients: results of the French AcSé-crizotinib trial. | 2023 |
| Crizotinib | Chemical | negative_correlate |
TRUST-II: a global phase II study of taletrectinib in <i>ROS1</i>-positive non-small-cell lung cancer and other solid tumors. | 2023 |
Showing 5 of 148 relation assertions.
Organizations publishing (524)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Hospital | 39 | 2013 to 2025 |
| Mass General Brigham | Hospital | 32 | 2014 to 2025 |
| Dana-Farber Cancer Institute | Other | 26 | 2014 to 2023 |
| The University of Texas System | Academic | 20 | 2014 to 2023 |
| Zhejiang Cancer Hospital | Hospital | 19 | 2017 to 2026 |
Showing 5 of 524 organizations.
Where ROS1 appears
- biological_process
- cancer or benign tumor
- cardiovascular disease
- disorder of visual system
- endocrine system disease
- gastrointestinal disease
- genetic, familial or congenital disease
- immune system disease
- integumentary system disease
- measurement
- phenotype
- reproductive system or breast disease
- respiratory or thoracic disease
396 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects and human sample screening reference.