Table 1.

Design and assays used in preapproval studies

Study 1Study 2Study 3
Study nameSpecificityCutoffDeeP-C
DesignCohortCase–controlCohort
ParticipantsLow-risk patients, recruited after negative colonoscopyCases referred for surveillance or known colorectal neoplasm, asymptomatic average-risk controlsAverage-risk patients due for CRC screening
Methylated DNA markersBMP3a NDRG4a TFPI2 VimentinBMP3a NDRG4aBMP3a NDRG4a
Mutant DNA markersKRASKRAS
Normalizing DNA markerβ-Actinaβ-Actinaβ-Actina
FITYesYes
  • Abbreviation: CRC, colorectal cancer.

  • aMarkers used in calibrated analysis.