Gene
PIK3CA
PIK3CA is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (7), Assay-provider ledger (183), Actionable biomarkers (22), 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 PIK3CA. 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 4 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 78 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 27 of 8,738 | 0.31% | not measured | |
| 2025 | 25 of 8,875 | 0.28% | not measured | |
| 2024 | 16 of 8,597 | 0.19% | not measured | |
| 2023 | 23 of 8,275 | 0.28% | 131 of 11,460 | 1.14% |
| 2022 | 26 of 8,285 | 0.31% | 134 of 13,598 | 0.99% |
| 2021 | 28 of 8,692 | 0.32% | 176 of 15,045 | 1.17% |
| 2020 | 22 of 7,640 | 0.29% | 138 of 14,459 | 0.95% |
| 2019 | 11 of 7,300 | 0.15% | 137 of 12,159 | 1.13% |
| 2018 | 19 of 6,927 | 0.27% | 116 of 11,854 | 0.98% |
| 2017 | 12 of 6,558 | 0.18% | 129 of 11,595 | 1.11% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (7)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| FoundationOne CDx | PIK3CA | Foundation Medicine, Inc. | Breast Cancer | 2026-05-27 |
| MI Cancer Seek (MCS) | PIK3CA | Caris Life Sciences | Breast Cancer | 2024-11-05 |
| FoundationOne Liquid CDx | PIK3CA | Foundation Medicine, Inc. | Breast Cancer | 2024-10-10 |
| FoundationOne CDx | PIK3CA | Foundation Medicine, Inc. | Breast Cancer | 2023-11-16 |
| FoundationOne Liquid CDx | PIK3CA | Foundation Medicine, Inc. | Breast Cancer | 2020-10-26 |
Showing 5 of 7 companion diagnostic entries.
Assay-provider ledger (183)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| THERMO FISHER SCIENTIFIC (Click-iT EdU kit, TaqMan Low-Density Array reagents, ExpressionSuite/DataAssist software) | Reagent supplier | Clinical validationAnalytical validation | 21 | June 01, 2026 |
| University of Pittsburgh Medical Center | Not a company | Clinical validationAnalytical validation | 2 | April 01, 2026 |
| Celemics | Diagnostic provider | Clinical validationAnalytical validation | 1 | February 10, 2026 |
| Pharos iBio Co., Ltd | Diagnostic provider | Clinical validationAnalytical validation | 1 | February 10, 2026 |
| AmoyDx | Diagnostic provider | Clinical validationAnalytical validation | 1 | December 08, 2025 |
Showing 5 of 183 assay-provider companies.
Actionable biomarkers (22)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| PIK3CA oncogenic mutation | Akt Inhibitors | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| PIK3CA amplification | Pi3k Pathway Inhibitors | responsive | breast adenocarcinoma | Cancer Genome Interpreter |
| PIK3CA oncogenic mutation | Pi3k Pathway Inhibitors | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| PIK3CA oncogenic mutation | Pik3ca Inhibitors | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| PIK3CA oncogenic mutation + ERBB2 amplification | TRASTUZUMAB | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
Showing 5 of 22 actionable-biomarker assertions.
Trial mentions (309)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT04050345 | Trial biospecimen (AACT) |
| NCT04683757 | Trial biospecimen (AACT) |
| NCT02821507 | Trial eligibility (AACT) |
| NCT01776008 | Trial eligibility (AACT) |
| NCT05759949 | Trial eligibility (AACT) |
Showing 5 of 309 trial mentions.
Target-disease associations (1,324)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| ACTH-Producing Pituitary Gland Adenoma | cancer or benign tumor | Cancer Gene Census |
| AIDS dementia | infectious disease | Literature (Europe PMC) |
| AKT2-related familial partial lipodystrophy | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| Aarskog-Scott syndrome, X-linked | genetic, familial or congenital disease | Literature (Europe PMC) |
| Abdominal Aortic Aneurysm | cardiovascular disease | Literature (Europe PMC) |
Showing 5 of 1,324 associations.
Vendor sourcing (1,025)
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 | The variant is not observed in the gnomAD v4.1.0 dataset. Predicted Consequence/Location: Missense variant. Missense changes are a common disease-causing mec... | View ClinVar record SCV002012040.2 |
| A&G Pharmaceutical (United States) | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures. 2. 18 years of age or older. 3. Histolog... | View trial NCT05627960 |
| A&G Pharmaceutical (United States) | Trial sponsor | Mentioned in trial textTrial free-text mention | PIK3CA | View trial NCT05627960 |
| ARUP Laboratories (United States) | Testing lab / CRO (runs the assay) | Clinical-testing interpretation submitted (ClinVar)ClinVar clinical-testing submission | No supporting text recorded; see the citation. | View ClinVar record SCV001159538.5 |
| AZ Sint-Jan AV | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | for breast cancer: 8.1. Non-metastatic breast cancer (M0): * No prior treatment for the current breast cancer. * All 3 criteria required: * Clinical stag... | View trial NCT05423808 |
Showing 5 of 1,025 sourcing records.
Trial-cited literature (1,569)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Osimertinib with or without savolitinib as first-line treatment for MET-aberrant, EGFR-mutant NSCLC: randomized phase 2 trial (FLOWERS). | Nature communications | 2026 | 4 |
| Proteogenomic profiling predicts outcomes of adjuvant chemotherapy in extrahepatic cholangiocarcinoma. | Journal of hepatology | 2026 | 2 |
| A neoantigen vaccine generates antitumour immunity in renal cell carcinoma. | Nature | 2025 | 151 |
| Overall Survival with Inavolisib in <i>PIK3CA</i>-Mutated Advanced Breast Cancer. | The New England journal of medicine | 2025 | 84 |
| Abemaciclib Plus Fulvestrant in Advanced Breast Cancer After Progression on CDK4/6 Inhibition: Results From the Phase III postMONARCH Trial. | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 2025 | 82 |
Showing 5 of 1,569 papers.
Protein variant mentions (101)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A1020T | 1 | 2015 | PMID 26452060 |
| p.A1035V | 1 | 2017 | PMID 28750640 |
| p.A1046V | 2 | 2013 to 2017 | PMID 28750640, PMID 23066039 |
| p.A1047R | 1 | 2018 | PMID 29437753 |
| p.A1047X | 1 | 2018 | PMID 29437753 |
Showing 5 of 101 variants.
Human sample screening reference (18)
Shown in this order: alphabetical by variant.
| Variant | GDC project | Disease / site | Affected cases | Profiled cases | Observed frequency | 95% interval |
|---|---|---|---|---|---|---|
| p.A1020T | TCGA-UCEC | Not Reported; Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Corpus uteri; Uterus, NOS | 1 | 559 | 0.18% | 0.03% to 1.01% |
| p.C378R | TCGA-STAD | Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Stomach | 1 | 443 | 0.23% | 0.04% to 1.27% |
| p.C378R | TCGA-UCEC | Not Reported; Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Corpus uteri; Uterus, NOS | 1 | 559 | 0.18% | 0.03% to 1.01% |
| p.D1018N | 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.D350G | 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 18 cohort observations.
Literature-extracted relations (447)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| FULVESTRANT | Chemical | associate |
Overall Survival with Inavolisib in <i>PIK3CA</i>-Mutated Advanced Breast Cancer. | 2025 |
| FULVESTRANT | Chemical | associate |
Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study. | 2024 |
| CELECOXIB | Chemical | associate |
Improved Survival With Adjuvant Cyclooxygenase 2 Inhibition in <i>PIK3CA</i>-Activated Stage III Colon Cancer: CALGB/SWOG 80702 (Alliance). | 2024 |
| TRASTUZUMAB | Chemical | associate |
Antitumor activity of the PI3K δ-sparing inhibitor MEN1611 in PIK3CA mutated, trastuzumab-resistant HER2 + breast cancer. | 2023 |
| TRASTUZUMAB | Chemical | associate |
A phase II randomised study of preoperative trastuzumab alone or combined with everolimus in patients with early HER2-positive breast cancer and predictive biomarkers (RADHER trial). | 2021 |
Showing 5 of 447 relation assertions.
Organizations publishing (889)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Hospital | 156 | 2008 to 2025 |
| Dana-Farber Cancer Institute | Other | 106 | 2009 to 2025 |
| The University of Texas System | Academic | 104 | 2009 to 2025 |
| Harvard Medical School | Academic | 74 | 2009 to 2025 |
| Mass General Brigham | Hospital | 69 | 2009 to 2025 |
Showing 5 of 889 organizations.
Where PIK3CA 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
- musculoskeletal or connective tissue disease
- nervous system disease
- nutritional or metabolic disease
- phenotype
- pregnancy or perinatal disease
- psychiatric disorder
- reproductive system or breast disease
- respiratory or thoracic disease
- urinary system disease
1,034 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.