TABLE A-7 Clinical/Biological Validation Studies for AlloMap


Study CARGO Primary Clinical Validation Study (Deng et al., 2006) CARGO Secondary Clinical Validation Study (Deng et al., 2006) CARGO Prevalent Population Study (Deng et al., 2006) CARGO Dataset Used for FDA Clearance (k073482)

Tissue source CARGO trial CARGO trial CARGO trial CARGO trial
Test platform qRT-PCR and EMB qRT-PCR and EMB qRT-PCR and EMB qRT-PCR and EMB
Study question Does AlloMap distinguish rejection from no rejection? Does AlloMap distinguish rejection from no rejection? Does AlloMap distinguish rejection from no rejection in samples representing expected clinical population? Does AlloMap distinguish rejection from no rejection in samples representing the expected clinical population?
Study design Prospective Not marker directed Prospective Not marker directed Prospective Not marker directed Prospective Not marker directed
Patient characteristics Time posttransplant not stated Time posttransplant not stated ≥1 year posttransplant > 55 days posttransplant, > 30 days post rejection treatment
Sample number 63 samples; 63 patients 184 samples; 124 patients 281 samples; 166 patients 300 samples; 154 patients
Blinding Yes Yes Yes Yes
Independence Different specimens than used in discovery All specimens used in primary clinical validation plus some specimens used in discovery Different specimens than used in discovery Different specimens than used in discovery
    Development involved XDx and transplant cardiologists directing CARGOa Development involved XDx and transplant cardiologists directing CARGO Development involved XDx and transplant cardiologists directing CARGO Development involved XDx and transplant cardiologists directing CARGO


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