FOUNDATIONAL SCIENCE
Foundational Science
The studies below were conducted by other organizations. They illustrate the scientific basis for cell-free DNA methylation and fragmentation approaches to cancer detection. They do not describe the performance of the EarlySignal test.
SELECTED PEER-REVIEWED STUDIES
Selected peer-reviewed studies
The studies below were conducted by other organizations and provide evidence for cell-free DNA
methylation and fragmentation approaches to cancer detection.
Study
Journal, year
What it reported
Annals of Oncology, 2020
6,689 participants (2,482 with cancer, 4,207 without); validation specificity 99.3%; tissue of origin accurate in 93% of samples where it was predicted
Annals of Oncology, 2021
High specificity and accurate prediction of cancer signal origin across a wide range of cancers; 55% of cancer cases were stage I to II
Cancer Cell, 2022
Compared whole-genome, methylation and deep targeted sequencing; whole-genome methylation classifiers had among the highest sensitivities at 98% specificity
Cancer Discovery, 2024
Prospective case-control study of 958 screening-eligible individuals, with separate training and validation groups
New England Journal of Medicine, 2024
Pivotal data for a cell-free DNA colorectal screening blood test
JAMA, 2025
Prospective validation of a methylation blood test against colonoscopy in average-risk adults
ES-001
Design
Prospective, multi-center, case-control
Population
Target number, age range, screening-eligible or symptomatic, cancer types
Primary objective
To evaluate the analytical and clinical performance of the EarlySignal multi-cancer blood test.
Registry ID
NCT01234567
Results
Pending
ES-002
Design
Prospective, multi-center
Population
Target number, age range, screening-eligible, multiple cancer types
Primary objective
To assess performance in an independent cohort.
Registry ID
NCT07654321
Results
Pending
EarlySignal’s own studies and publications will appear on
Clinical Studies and Publications.
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