Gene
PTEN
PTEN is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (2), Assay-provider ledger (182), Actionable biomarkers (45), 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 PTEN. 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 a planned future start and 1 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 44 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 22 of 8,738 | 0.25% | not measured | |
| 2025 | 21 of 8,875 | 0.24% | not measured | |
| 2024 | 25 of 8,597 | 0.29% | not measured | |
| 2023 | 13 of 8,275 | 0.16% | 132 of 11,460 | 1.15% |
| 2022 | 19 of 8,285 | 0.23% | 141 of 13,598 | 1.04% |
| 2021 | 16 of 8,692 | 0.18% | 193 of 15,045 | 1.28% |
| 2020 | 18 of 7,640 | 0.24% | 144 of 14,459 | 1.00% |
| 2019 | 18 of 7,300 | 0.25% | 166 of 12,159 | 1.37% |
| 2018 | 17 of 6,927 | 0.25% | 137 of 11,854 | 1.16% |
| 2017 | 16 of 6,558 | 0.24% | 157 of 11,595 | 1.35% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (2)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| VENTANA PTEN (SP218) RxDx Assay (Ventana Medical Systems, Inc.) | PTEN | Roche Tissue Diagnostics | Metastatic hormone-sensitive prostate cancer (mHSPC) | 2026-06-12 |
| FoundationOne CDx | PTEN | Foundation Medicine, Inc. | Breast Cancer | 2023-11-16 |
Assay-provider ledger (182)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| Agilent | Reagent supplier | Clinical validationAnalytical validation | 5 | July 01, 2026 |
| BioCare Medical, Pacheco, CA | Reagent supplier | Clinical validation | 1 | July 01, 2026 |
| Cancer Diagnostics, Durham, NC | Reagent supplier | Clinical validation | 1 | July 01, 2026 |
| Bon Yakhteh | Reagent supplier | Clinical validation | 1 | June 08, 2026 |
| DiaSorin | Diagnostic provider | Clinical validation | 1 | June 08, 2026 |
Showing 5 of 182 assay-provider companies.
Actionable biomarkers (45)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| PTEN biallelic inactivation | Byl719 | responsive | breast adenocarcinoma | Cancer Genome Interpreter |
| PTEN oncogenic mutation + ERBB2 amplification | TRASTUZUMAB | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| PTEN oncogenic mutation | Atm Inhibitors | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| PTEN deletion | Pi3k Pathway Inhibitors | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| PTEN oncogenic mutation | Pi3k Pathway Inhibitors | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
Showing 5 of 45 actionable-biomarker assertions.
Trial mentions (323)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT02573636 | Trial biospecimen (AACT) |
| NCT07297134 | Trial biospecimen (AACT) |
| NCT02461446 | Trial biospecimen (AACT) |
| NCT07597369 | Trial biospecimen (AACT) |
| NCT00975819 | Trial eligibility (AACT) |
Showing 5 of 323 trial mentions.
Target-disease associations (1,358)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| 15q11q13 microduplication syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 46,XX ovotesticular disorder of sex development | endocrine system disease | Mouse knockout (IMPC) |
| 46,XY complete gonadal dysgenesis | cardiovascular disease | Mouse knockout (IMPC) |
| 46,XY partial gonadal dysgenesis | endocrine system disease | Mouse knockout (IMPC) |
| 46,XY sex reversal 11 | cardiovascular disease | Mouse knockout (IMPC) |
Showing 5 of 1,358 associations.
Vendor sourcing (1,078)
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 | Frameshift: predicted to result in a loss or disruption of normal protein function through nonsense-mediated decay (NMD) or protein truncation. Multiple path... | View ClinVar record SCV002012006.1 |
| ARUP Laboratories (United States) | Testing lab / CRO (runs the assay) | Clinical-testing interpretation submitted (ClinVar)ClinVar clinical-testing submission | The PTEN c.-899_-878dup variant (rs1348857174), to our knowledge, is not reported in the medical literature but is reported in ClinVar (Variation ID: 619909)... | View ClinVar record SCV007331375.1 |
| AbbVie Inc. | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Children ≥ 2 years and ≤ 18 years of age at the time of first diagnosis and less than 21 years at the time of inclusion 2. Performance status: Karnofsk... | View trial NCT07175415 |
| AbbVie Inc. | Trial collaborator | Mentioned in trial textTrial free-text mention | PTEN | View trial NCT07175415 |
| Academic and Community Cancer Research United | Trial sponsor | Exploratory endpoint in a trialTrial endpoint | Cell Free Tumor Deoxyribonucleic Acid (cfDNA) | View trial NCT03992456 |
Showing 5 of 1,078 sourcing records.
Trial-cited literature (1,975)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. | Annals of oncology : official journal of the European Society for Medical Oncology | 2026 | 29 |
| Identification of Renal Transcripts Associated with Kidney Function and Prognosis in ANCA-Associated Vasculitis. | Journal of the American Society of Nephrology : JASN | 2026 | 5 |
| Low-Dose Aspirin for PI3K-Altered Localized Colorectal Cancer. | The New England journal of medicine | 2025 | 52 |
| Lutetium-177-PSMA-617 or cabazitaxel in metastatic prostate cancer: circulating tumor DNA analysis of the randomized phase 2 TheraP trial. | Nature medicine | 2025 | 37 |
| 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 |
Showing 5 of 1,975 papers.
Protein variant mentions (157)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A126S | 1 | 2020 | PMID 32864625 |
| p.A359S | 1 | 2016 | PMID 26467025 |
| p.A3V | 1 | 2015 | PMID 25741868 |
| p.A86V | 1 | 2015 | PMID 25741868 |
| p.C136R | 2 | 2010 to 2015 | PMID 25741868, PMID 20600018 |
Showing 5 of 157 variants.
Human sample screening reference (28)
Shown in this order: alphabetical by variant.
| Variant | GDC project | Disease / site | Affected cases | Profiled cases | Observed frequency | 95% interval |
|---|---|---|---|---|---|---|
| p.A126S | CPTAC-3 | Not Applicable; Transitional Cell Papillomas and Carcinomas; Ductal and Lobular Neoplasms; Adenomas and Adenocarcinomas; Gliomas; Epithelial Neoplasms, NOS; Complex Epithelial Neoplasms; Complex Mixed and Stromal Neoplasms; Lipomatous Neoplasms; Squamous Cell Neoplasms; Myeloid Leukemias; Nevi and Melanomas; Stomach; Other and ill-defined sites in lip, oral cavity and pharynx; Unknown; Colon; Other and unspecified urinary organs; Floor of mouth; Other and unspecified parts of mouth; Gum; Bronchus and lung; Oropharynx; Other and unspecified parts of tongue; Base of tongue; Breast; Other and ill-defined sites; Larynx; Lip; Uterus, NOS; Hematopoietic and reticuloendothelial systems; Kidney; Brain; Skin; Pancreas; Tonsil | 1 | 1,815 | 0.06% | 0.01% to 0.31% |
| p.A126S | TCGA-UCEC | Not Reported; Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Corpus uteri; Uterus, NOS | 2 | 559 | 0.36% | 0.10% to 1.30% |
| p.I67R | ALCHEMIST-ALCH | Not Reported; Not Reported | 1 | 1,170 | 0.09% | 0.02% to 0.48% |
| p.R130* | ALCHEMIST-ALCH | Not Reported; Not Reported | 3 | 1,170 | 0.26% | 0.09% to 0.75% |
| p.R130* | 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% |
Showing 5 of 28 cohort observations.
Literature-extracted relations (446)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| FULVESTRANT | Chemical | associate |
US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer With <i>PIK3CA</i>/<i>AKT1</i>/<i>PTEN</i> Alterations. | 2024 |
| BORTEZOMIB | Chemical | associate |
Bortezomib in previously treated phosphatase and tension homology-deficient patients with advanced intrahepatic cholangiocarcinoma: An open-label, prospective and single-centre phase II trial. | 2024 |
| PREDNISOLONE | Chemical | negative_correlate |
Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial. | 2021 |
| FULVESTRANT | Chemical | associate |
Selective AKT kinase inhibitor capivasertib in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer. | 2021 |
| LACTIC ACID (Dermacid) | Chemical | associate |
Hyperpolarized MRI of Human Prostate Cancer Reveals Increased Lactate with Tumor Grade Driven by Monocarboxylate Transporter 1. | 2020 |
Showing 5 of 446 relation assertions.
Organizations publishing (1,021)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Hospital | 117 | 2004 to 2025 |
| The University of Texas System | Academic | 101 | 2004 to 2025 |
| Dana-Farber Cancer Institute | Other | 92 | 2004 to 2025 |
| Government of the United States of America | Government | 83 | 2009 to 2025 |
| Harvard Medical School | Academic | 67 | 2002 to 2025 |
Showing 5 of 1,021 organizations.
Where PTEN 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
- 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
- urinary system disease
1,041 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.