The development and clinical validation of the test used patient samples and clinical data obtained during the Cardiac Allograft Rejection Gene Expression Observational (CARGO) Study. From 2001 to 2005, 737 patients from nine U.S. transplant centers enrolled in the Study and contributed 5,834 blood samples and associated clinical data.<ref name="Deng"/> Initial clinical experience at three medical centers was published in 2006, confirming the efficacy and performance of the test.<ref name="Starling"/>
=== IMAGE Study ===
A comparative effectiveness study, the Invasive Monitoring Attenuation through Gene Expression (IMAGE) Study, compared clinical outcomes of patients managed with AlloMap to outcomes of patients managed with endomyocardial biopsy. The study, which ran from 2005–09, included 602 patients from thirteen U.S. centers who were at least six months post-transplant. The results showed that AlloMap was not inferior to endomyocardial biopsy with respect to clinical outcomes when used to monitor stable, asymptomatic heart transplant patients.<ref>{{cite journal |last1=Pham |first1=MX |last2=Teuteberg |first2=JJ |last3=Kfoury |first3=AG |last4=Starling |first4=RC |last5=Deng |first5=MC |last6=Cappola |first6=TP |last7=Kao |first7=A |last8=Anderson |first8=AS |last9=Cotts |first9=WG |displayauthors=8|title=Gene-expression profiling for rejection surveillance after cardiac transplantation |journal=The New England Journal of Medicine |volume=362 |issue=20 |pages=1890–900 |year=2010 |pmid=20413602 |doi=10.1056/NEJMoa0912965}}</ref>
