Gene
KRAS
KRAS is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (20), Assay-provider ledger (306), Actionable biomarkers (57), 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 KRAS. 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: 4 with a planned future start and 10 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 1 dated before 1990 and 129 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 136 of 8,738 | 1.56% | not measured | |
| 2025 | 127 of 8,875 | 1.43% | not measured | |
| 2024 | 134 of 8,597 | 1.56% | not measured | |
| 2023 | 90 of 8,275 | 1.09% | 255 of 11,460 | 2.23% |
| 2022 | 95 of 8,285 | 1.15% | 238 of 13,598 | 1.75% |
| 2021 | 61 of 8,692 | 0.70% | 267 of 15,045 | 1.77% |
| 2020 | 65 of 7,640 | 0.85% | 237 of 14,459 | 1.64% |
| 2019 | 54 of 7,300 | 0.74% | 253 of 12,159 | 2.08% |
| 2018 | 47 of 6,927 | 0.68% | 219 of 11,854 | 1.85% |
| 2017 | 42 of 6,558 | 0.64% | 223 of 11,595 | 1.92% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (20)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| Guardant360® Liquid CDx | KRAS | Guardant Health, Inc. | Non-small cell lung cancer (NSCLC) | 2026-05-19 |
| therascreen KRAS RGQ PCR Kit | KRAS | Qiagen Manchester, Ltd. | Colorectal Cancer | 2025-01-16 |
| MI Cancer Seek (MCS) | KRAS | Caris Life Sciences | Colorectal Cancer | 2024-11-05 |
| therascreen KRAS RGQ PCR Kit | KRAS | Qiagen Manchester, Ltd. | Colorectal Cancer | 2024-06-21 |
| CRCDx RAS Mutation Detection Assay Kit | KRAS | EntroGen, Inc. | Colorectal Cancer (CRC) | 2023-09-29 |
Showing 5 of 20 companion diagnostic entries.
Assay-provider ledger (306)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| Clinical Genomics (Colvera) | Diagnostic provider | Clinical validation | 1 | August 15, 2026 |
| DiaCarta | Diagnostic provider | Clinical validation | 1 | August 15, 2026 |
| Freenome | Diagnostic provider | Clinical validation | 1 | August 15, 2026 |
| Guardant Health | Diagnostic provider | Clinical validationAnalytical validation | 4 | August 15, 2026 |
| New Day Diagnostics | Diagnostic provider | Clinical validation | 1 | August 15, 2026 |
Showing 5 of 306 assay-provider companies.
Actionable biomarkers (57)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| KRAS (G12) | Mek Inhibitors | response-associated | acute lymphoblastic leukemia | Cancer Genome Interpreter |
| KRAS oncogenic mutation | Mek Inhibitors | response-associated | acute myeloid leukemia | Cancer Genome Interpreter |
| KRAS oncogenic mutation | Mek Inhibitors | response-associated | biliary tract neoplasm | Cancer Genome Interpreter |
| KRAS oncogenic mutation | Mek Inhibitors | response-associated | cervical carcinoma | Cancer Genome Interpreter |
| KRAS oncogenic mutation | Cdk4/6 Inhibitor + Mek Inhibitors | response-associated | cervical squamous cell carcinoma | Cancer Genome Interpreter |
Showing 5 of 57 actionable-biomarker assertions.
Trial mentions (1,235)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT07775859 | Trial biospecimen (AACT) |
| NCT05365412 | Trial biospecimen (AACT) |
| NCT01740804 | Trial biospecimen (AACT) |
| NCT04050345 | Trial biospecimen (AACT) |
| NCT02823210 | Trial biospecimen (AACT) |
Showing 5 of 1,235 trial mentions.
Target-disease associations (1,375)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| 2-hydroxyglutaric aciduria | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| AIDS dementia | infectious disease | Literature (Europe PMC) |
| APC-related attenuated familial adenomatous polyposis | cancer or benign tumor | Mouse knockout (IMPC) |
| ATTRV122I amyloidosis | cardiovascular disease | Mouse knockout (IMPC) |
| Abnormality of the cardiovascular system | phenotype | Variant curation (ClinVar / EVA) |
Showing 5 of 1,375 associations.
Vendor sourcing (3,751)
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 | A different missense change at the same codon has been reported to be associated with KRAS related disorder (PMID:20810036, PM5_P). In silico tool prediction... | View ClinVar record SCV002058536.1 |
| ADIR, a Servier Group company | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | : * Histologically or cytologically confirmed adenocarcinoma of metastatic colorectal cancer (mCRC), not amenable to surgical intervention due to either med... | View trial NCT05223673 |
| ADIR, a Servier Group company | Trial collaborator | Primary endpoint in a Phase 3 trialTrial endpoint | Overall Survival (OS) (In Double Negative, KRAS/NRAS and BRAF Wild Type Patients) (Phase III Part) | View trial NCT05223673 |
| ADIR, a Servier Group company | Trial collaborator | Mentioned in trial textTrial free-text mention | KRAS | View trial NCT05223673 |
| AIO Studien gGmbH | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | : * Age ≥ 18 years. * Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma. * Proven KRAS G12C mutatio... | View trial NCT07124884 |
Showing 5 of 3,751 sourcing records.
Trial-cited literature (3,058)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Target antigen and plasma cell phenotype are critical factors for sensitivity to response-adapted daratumumab therapy. | Blood | 2026 | 4 |
| Biomarker analysis from a Phase 1/1b study of tusamitamab ravtansine in patients with advanced non-small cell lung cancer. | Translational oncology | 2026 | 3 |
| Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: A pooled analysis of phase 1/2 study. | European journal of cancer (Oxford, England : 1990) | 2026 | 3 |
| A phase 2 study of orally administered live biotherapeutic salmonella-IL2 with FOLFIRINOX for stage IV pancreatic cancer. | Cancer immunology, immunotherapy : CII | 2026 | 2 |
| Proteogenomic profiling predicts outcomes of adjuvant chemotherapy in extrahepatic cholangiocarcinoma. | Journal of hepatology | 2026 | 2 |
Showing 5 of 3,058 papers.
Protein variant mentions (69)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A130V | 2 | 2015 to 2019 | PMID 31605946, PMID 25741868 |
| p.A146V | 16 | 2005 to 2023 | PMID 37364334, PMID 33771889, PMID 32314268 |
| p.A2650V | 1 | 2017 | PMID 26681737 |
| p.A302S | 1 | 2018 | PMID 30241526 |
| p.C30N | 1 | 2022 | PMID 34750076 |
Showing 5 of 69 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.Q99L | CPTAC-2 | Not Reported; Cystic, Mucinous and Serous Neoplasms; Adenomas and Adenocarcinomas; Ductal and Lobular Neoplasms; Squamous Cell Neoplasms; Other and unspecified female genital organs; Colon; Breast; Retroperitoneum and peritoneum; Rectum; Ovary | 1 | 328 | 0.30% | 0.05% to 1.71% |
| p.R68S | HCMI-CMDC | Ductal and Lobular Neoplasms; Complex Mixed and Stromal Neoplasms; Blood Vessel Tumors; Fibromatous Neoplasms; Epithelial Neoplasms, NOS; Mature T- and NK-Cell Lymphomas; Transitional Cell Papillomas and Carcinomas; Complex Epithelial Neoplasms; Squamous Cell Neoplasms; Soft Tissue Tumors and Sarcomas, NOS; Lymphoid Leukemias; Cystic, Mucinous and Serous Neoplasms; Gliomas; Myomatous Neoplasms; Neuroepitheliomatous Neoplasms; Malignant Lymphomas, NOS or Diffuse; Acinar Cell Neoplasms; Osseous and Chondromatous Neoplasms; Synovial-like Neoplasms; Miscellaneous Bone Tumors; Nevi and Melanomas; Adenomas and Adenocarcinomas; Other and unspecified parts of tongue; Stomach; Bronchus and lung; Larynx; Uterus, NOS; Kidney; Esophagus; Other and ill-defined sites; Skin; Colon; Thyroid gland; Bladder; Adrenal gland; Eye and adnexa; Gallbladder; Connective, subcutaneous and other soft tissues; Rectosigmoid junction; Breast; Pancreas; Small intestine; Corpus uteri; Other and unspecified parts of mouth; Liver and intrahepatic bile ducts; Nasal cavity and middle ear; Hematopoietic and reticuloendothelial systems; Brain; Other and unspecified parts of biliary tract; Bones, joints and articular cartilage of other and unspecified sites; Rectum; Unknown; Lymph nodes; Ovary | 1 | 606 | 0.17% | 0.03% to 0.93% |
| p.R68S | TCGA-COAD | Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Complex Epithelial Neoplasms; Rectosigmoid junction; Colon | 1 | 461 | 0.22% | 0.04% to 1.22% |
Literature-extracted relations (1,053)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| LENALIDOMIDE | Chemical | positive_correlate |
Target antigen and plasma cell phenotype are critical factors for sensitivity to response-adapted daratumumab therapy. | 2026 |
| DOCETAXEL | Chemical | associate |
Intracranial activity of sotorasib vs docetaxel in pretreated KRAS G12C-mutated advanced non-small cell lung cancer from a global, phase 3, randomized controlled trial. | 2025 |
| DOCETAXEL | Chemical | associate |
Sotorasib versus docetaxel for previously treated KRAS G12C-mutated non-small-cell lung cancer: a plain language summary. | 2025 |
| BEVACIZUMAB | Chemical | associate |
Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of <i>KRAS</i>-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial. | 2025 |
| BEVACIZUMAB | Chemical | associate |
Onvansertib in Combination with FOLFIRI and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Phase Ib Clinical Study. | 2024 |
Showing 5 of 1,053 relation assertions.
Organizations publishing (1,215)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Hospital | 208 | 2005 to 2025 |
| The University of Texas System | Academic | 176 | 2003 to 2026 |
| Dana-Farber Cancer Institute | Other | 142 | 2005 to 2025 |
| Government of the United States of America | Government | 115 | 1997 to 2025 |
| Mayo Clinic | Hospital | 115 | 2008 to 2025 |
Showing 5 of 1,215 organizations.
Where KRAS 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
- pregnancy or perinatal disease
- reproductive system or breast disease
- respiratory or thoracic disease
- urinary system disease
1,065 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.