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Gene

TP53

TP53 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 (461), Actionable biomarkers (15), and 8 more evidence types, each linked to its source.

Ensembl ENSG00000141510 UniProt P04637 Matched to Ensembl and UniProt
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FDA companion diagnostic assertions FDA companion diagnostic assertions 1 Assay-provider ledger Assay-provider ledger 461 Actionable biomarkers Actionable biomarkers 15 Trial mentions Trial mentions 553 Target-disease associations Target-disease associations 2,615 Vendor sourcing Vendor sourcing 1,959 Trial-cited literature Trial-cited literature 5,485 Protein variant mentions Protein variant mentions 335 FDA companion diagnostic assertions FDA companion diagnostic assertions 1 Assay-provider ledger Assay-provider ledger 461 Actionable biomarkers Actionable biomarkers 15 Trial mentions Trial mentions 553 Target-disease associations Target-disease associations 2,615 Vendor sourcing Vendor sourcing 1,959 Trial-cited literature Trial-cited literature 5,485 Protein variant mentions Protein variant mentions 335

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.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

Evidence over time

Share of that year: what fraction of the trials and papers our biomarker dictionary matched in a year mention TP53. 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.

Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 215 at the structurally incomplete recent edge.

The yearly numbers
TP53 per year, by evidence type, the most recent 10 years, newest first; the chart covers 1990 to 2026. The share is of the trials and papers our biomarker dictionary matched that year, not of the literature at large, and a blank year is one our matched corpus does not cover at all.
Year Trial mentions Share of that year Publication mentions Share of that year
2026 75 of 8,738 0.86% not measured
2025 52 of 8,875 0.59% not measured
2024 61 of 8,597 0.71% not measured
2023 45 of 8,275 0.54% 420 of 11,460 3.66%
2022 42 of 8,285 0.51% 489 of 13,598 3.60%
2021 45 of 8,692 0.52% 533 of 15,045 3.54%
2020 33 of 7,640 0.43% 425 of 14,459 2.94%
2019 41 of 7,300 0.56% 393 of 12,159 3.23%
2018 42 of 6,927 0.61% 376 of 11,854 3.17%
2017 18 of 6,558 0.27% 354 of 11,595 3.05%

Showing 10 of 37 years.

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FDA companion diagnostic assertions (1)

Shown in this order: most recent decision first.

FDA companion diagnostic assertions
Diagnostic Source biomarker wording Manufacturer Indication Decision date
Vysis CLL FISH Probe Kit TP53 Abbott Molecular, Inc. B-cell Chronic Lymphocytic Leukemia 2016-04-11

Assay-provider ledger (461)

Shown in this order: most recent publication first.

Assay-provider ledger
Company Provider class Validation Papers Most recent publication
Foundation Medicine Diagnostic provider Clinical validationAnalytical validation 16 August 01, 2026 +1 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 26 August 01, 2026 +3 undated
University of Pittsburgh Medical Center (UPMC) Molecular & Genomics Pathology (MGP) laboratory Not a company Clinical validationAnalytical validation 1 August 01, 2026
Diatech Pharmacogenetics Diagnostic provider Clinical validation 1 July 01, 2026

Showing 5 of 461 assay-provider companies.

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Actionable biomarkers (15)

Shown in this order: fixed catalogue order, not ranked.

Actionable biomarkers
Alteration Drug Response Disease Source
TP53 oncogenic mutation Decitabine response-associated Myelodysplastic/Myeloproliferative Neoplasm Cancer Genome Interpreter
TP53 oncogenic mutation CISPLATIN responsive Ovarian Germ Cell Tumor Cancer Genome Interpreter
TP53 oncogenic mutation Pramlintide response-associated Thymic Carcinoma Cancer Genome Interpreter
TP53 deletion Pramlintide response-associated Thymic Carcinoma Cancer Genome Interpreter
TP53 oncogenic mutation Decitabine response-associated acute myeloid leukemia Cancer Genome Interpreter

Showing 5 of 15 actionable-biomarker assertions.

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Trial mentions (553)

Shown in this order: fixed catalogue order, not by date.

Trial mentions
Trial Source
NCT02823210 Trial biospecimen (AACT)
NCT04050345 Trial biospecimen (AACT)
NCT04966923 Trial biospecimen (AACT)
NCT04683757 Trial biospecimen (AACT)
NCT05947851 Trial eligibility (AACT)

Showing 5 of 553 trial mentions.

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Target-disease associations (2,615)

Shown in this order: fixed catalogue order, not ranked.

Target-disease associations
Disease Therapeutic area Source
46,XY complete gonadal dysgenesis cardiovascular disease Mouse knockout (IMPC)
ACTH-Producing Pituitary Gland Adenoma cancer or benign tumor Cancer Gene Census
ACTH-Producing Pituitary Gland Adenoma cancer or benign tumor Literature (Europe PMC)
AIDS genetic, familial or congenital disease Literature (Europe PMC)
AIDS dementia infectious disease Literature (Europe PMC)

Showing 5 of 2,615 associations.

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Vendor sourcing (1,959)

Shown in this order: alphabetical by organization.

Vendor sourcing
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 observed at an extremely low frequency in the gnomAD v2.1.1 dataset (total allele frequency: 0.002%). Predicted Consequence/Location: The vari... View ClinVar record SCV002572762.3
A2A (Italy) Trial sponsor Named in trial inclusion criteriaTrial eligibility criteria : 1. Adults ≥ 18 years of age. 2. Patient has histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumors with TP53 m... View trial NCT06136884
A2A (Italy) Trial sponsor Mentioned in trial textTrial free-text mention TP53 View trial NCT06136884
ARUP Laboratories (United States) Testing lab / CRO (runs the assay) Clinical-testing interpretation submitted (ClinVar)ClinVar clinical-testing submission The TP53 c.848G>A; p.Arg283His variant (rs371409680), is reported in the literature in individuals affected with an astrocytoma or a glioblastoma (Fulci 2002... View ClinVar record SCV000605420.2
AVM Biotechnology (United States) Trial sponsor Named in trial inclusion criteriaTrial eligibility criteria : * 1\. Age ≥12 years and weight ≥40 kg; 2\. Histologically confirmed diagnosis per 2016 World Health Organization (WHO) classification of lymphoid neopl... View trial NCT04329728

Showing 5 of 1,959 sourcing records.

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Trial-cited literature (5,485)

Shown in this order: newest first, then most cited.

Trial-cited literature
Publication Journal Year Citations
Molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer (PORTEC-4a): results of a randomised, open-label, phase 3, multicentre, non-inferiority trial. The Lancet. Oncology 2026 34
Osimertinib with or without savolitinib as first-line treatment for MET-aberrant, EGFR-mutant NSCLC: randomized phase 2 trial (FLOWERS). Nature communications 2026 4
Epcoritamab monotherapy for Richter transformation (EPCORE CLL-1): findings from a single-arm, multicentre, open-label, phase 1b/2 trial. The Lancet. Haematology 2026 4
Genomic determinants of response and resistance to pirtobrutinib in relapsed/refractory chronic lymphocytic leukemia. Blood 2026 4
Dual FLT3/PIM inhibitor dapolsertib in acute myeloid leukemia: results from the phase 1/2 DIAMOND-01 trial. Blood neoplasia 2026 2

Showing 5 of 5,485 papers.

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Protein variant mentions (335)

Shown in this order: alphabetical by variant.

Protein variant mentions
Variant Distinct papers Year range Sample papers
p.A03D 1 2018 PMID 29617664
p.A135V 1 2019 PMID 30538286
p.A138T 1 2011 PMID 21458303
p.A159I 1 2015 PMID 26552420
p.A161T 5 2014 to 2021 PMID 33637876, PMID 34301788, PMID 31387111

Showing 5 of 335 variants.

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Human sample screening reference (135)

Shown in this order: alphabetical by variant.

Human sample screening reference
Variant GDC project Disease / site Affected cases Profiled cases Observed frequency 95% interval
p.A138T TCGA-GBM Gliomas; Not Reported; Brain 1 601 0.17% 0.03% to 0.94%
p.A161V 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%
p.A161V TCGA-LUAD Cystic, Mucinous and Serous Neoplasms; Ductal and Lobular Neoplasms; Acinar Cell Neoplasms; Adenomas and Adenocarcinomas; Bronchus and lung 1 573 0.17% 0.03% to 0.98%
p.D259N TCGA-HNSC Squamous Cell Neoplasms; Base of tongue; Lip; Gum; Hypopharynx; Palate; Other and ill-defined sites in lip, oral cavity and pharynx; Bones, joints and articular cartilage of other and unspecified sites; Other and unspecified parts of tongue; Floor of mouth; Tonsil; Other and unspecified parts of mouth; Oropharynx; Larynx 1 528 0.19% 0.03% to 1.06%
p.D259Y 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%

Showing 5 of 135 cohort observations.

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Literature-extracted relations (1,609)

Shown in this order: chemicals, then diseases.

Literature-extracted relations
Related entity Kind Source relation label Paper Year
Tamoxifen Chemical associate A predictive endocrine resistance index accurately stratifies luminal breast cancer treatment responders and nonresponders. 2025
Decitabine Chemical associate A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant TP53 and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years. 2025
AZACITIDINE (VIDAZA) Chemical negative_correlate Magrolimab plus azacitidine vs physician's choice for untreated TP53-mutated acute myeloid leukemia: the ENHANCE-2 study. 2025
Decitabine Chemical associate Impact of TP53 Mutation Status in Elderly AML Patients When Adding All-Trans Retinoic Acid or Valproic Acid to Decitabine. 2025
Tretinoin Chemical associate Impact of TP53 Mutation Status in Elderly AML Patients When Adding All-Trans Retinoic Acid or Valproic Acid to Decitabine. 2025

Showing 5 of 1,609 relation assertions.

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Organizations publishing (1,657)

Shown in this order: most papers first.

Organizations publishing
Organization Type Papers Years
The University of Texas System Academic 294 1998 to 2026
Memorial Sloan Kettering Cancer Center Hospital 279 1996 to 2026
Dana-Farber Cancer Institute Other 254 2001 to 2025
Government of the United States of America Government 237 1994 to 2025
Harvard Medical School Academic 186 2002 to 2025

Showing 5 of 1,657 organizations.

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Where TP53 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

1,993 diseases touched.

Not on this page

Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.

Browse all biomarker evidence pages