Organization (Industry)
Exact Sciences (United States)
ClinicalTrials.gov lists Exact Sciences (United States) as lead sponsor of 31 trials. It has 1 active development program.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 1 registered with a 2026 start date. The dashed outline is the pace from the 1 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 2.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Exact Sciences (United States): 31 lead-sponsored trials and 1 legal-entity registration.
Disease areas (31)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Colorectal Neoplasms | 22 |
| Breast Neoplasms | 3 |
| Colonic Neoplasms | 3 |
| Liver Neoplasms | 3 |
| Barrett Esophagus | 2 |
Showing 5 of 31 disease areas.
Trials by start year as sponsor or collaborator (15)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 1 |
| 2024 | 3 |
| 2023 | 3 |
| 2022 | 2 |
| 2021 | 2 |
| 2020 | 2 |
| 2019 | 6 |
| 2018 | 7 |
| 2017 | 1 |
| 2016 | 1 |
Showing 10 of 15 years.
Recruitment duration, a model prediction: none of the 31 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (1)
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| COVID-19 | COVID-19 | Not reported | 1 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 74% hit target (n=19) | 21% on time (n=19) |
Journals published in (12)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association | 4 |
| BMJ open gastroenterology | 2 |
| Cancer prevention research (Philadelphia, Pa.) | 2 |
| The New England journal of medicine | 2 |
| BMJ open | 1 |
Showing 5 of 12 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 106 | 44 | 2025-12-16 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 1 |
FDA recalls (1)
| Product | Classification | Initiated |
|---|---|---|
| Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests | Class II | 2017-04-28 |
Organization relationships (6)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Mayo Clinic | Co sponsors trial with | 2 |
| Government of the United States of America | Co sponsors trial with | 2 |
| Fortrea Holdings Inc. | Uses vendor | 1 |
| University of Colorado System | Co sponsors trial with | 1 |
| University of California System | Co sponsors trial with | 1 |
Showing 5 of 6 relationships.
Latest dated events (144)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-03-10 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-12-16 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-11-11 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-10-14 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-10-07 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 144 events.
CLIA clinical laboratory certificates (1)
| Lab | Certificate | Status |
|---|---|---|
| EXACT SCIENCES CORPORATION | Certificate of registration | Terminated |
Biomarker capability evidence (68)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| EPCAM | Trial collaborator | Named in trial inclusion criteria |
| ERBB2 | Trial sponsor | Named in trial inclusion criteria |
| ERBB2 | Trial collaborator | Named in trial inclusion criteria |
| HGD | Trial sponsor | Named in trial inclusion criteria |
| MLH1 | Trial collaborator | Named in trial inclusion criteria |
Showing 5 of 68 evidence rows.
On Scientist.com
Exact Sciences (United States) is listed as a research supplier in the Scientist.com network.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, approved assets, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda import refusals, manufacturing and distribution sites, climate targets, as filed, workforce and board diversity, as filed, and biomarkers this organization publishes on.
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