Clinical Information

AlloMap: Evidenced Based. Clinically Actionable Information.

AlloMap® was developed to fill a need for a non-invasive surveillance solution to assess the risk of transplant rejection. It has been the flagship product of CareDx® since 2005. Since inception, CareDx has achieved a number of milestones with its core technology:

 

timeline

 

AlloMap major clinical trials

These studies constitute perhaps the largest repository of observational and interventional study GEP-blood samples and clinical annotations including biopsy reports of heart transplant recipients ever assembled.

Download AlloMap and AlloMap Score Variability Key Publications.

Study Design Primary Outcomes Enrollment # Patients Timeframe Conducted
CARGO
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Observational, Cohort, Prospective Performance characteristics of GEP Test score correlated to centralized biopsy grades 629 2001-2005
CARGO II
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Observational, Cohort, Prospective Performance characteristics of GEP Test score correlated to centralized biopsy grades and correlation of GEP score stability with clinical outcomes 741 2005-2009
2009-2011
IMAGE
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Randomized, Prospective, Interventional First occurrence of rejection with HDC, graft dysfunction due to other causes, death, or re-transplantation 602 2005-2009
EIMAGE
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Randomized, Prospective, Interventional First occurrence of rejection with HDC, graft dysfunction due to other causes, death, or re-transplantation and IVUS measurement 60 2009-2012
OAR/DOAR
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Outcomes Registry Observe real world, short and long term clinical outcomes in heart transplant recipients who receive regular AlloMap testing as part of allograft rejection surveillance 2000 2013