Design and assays used in preapproval studies
Study 1 | Study 2 | Study 3 | |
---|---|---|---|
Study name | Specificity | Cutoff | DeeP-C |
Design | Cohort | Case–control | Cohort |
Participants | Low-risk patients, recruited after negative colonoscopy | Cases referred for surveillance or known colorectal neoplasm, asymptomatic average-risk controls | Average-risk patients due for CRC screening |
Methylated DNA markers | BMP3a NDRG4a TFPI2 Vimentin | BMP3a NDRG4a | BMP3a NDRG4a |
Mutant DNA markers | — | KRAS | KRAS |
Normalizing DNA marker | β-Actina | β-Actina | β-Actina |
FIT | — | Yes | Yes |
Abbreviation: CRC, colorectal cancer.
↵aMarkers used in calibrated analysis.