Join the
Registry
Shaping the future of transplant monitoring through real-world evidence.
The GALACTIC Registry (GraftAssure Lowering Allograft rejeCTIon by Combination) is an observational, multi-center study enrolling up to 5,000 kidney transplant recipients across 50 centers. By contributing real-world data, participating sites help evaluate new approaches to dd-cfDNA measurement and support the future of transplant diagnostics.
Advancing Real-World Evidence in Transplant Monitoring
Dd-cfDNA testing is reshaping how transplant teams detect and respond to graft rejection. Yet the field still lacks large-scale, real-world data comparing integrated, absolute, and relative measurement approaches across diverse patient populations.
Exclusive to the GraftAssure platform, the GraftAssure™ Combination Model Score integrates the relative and absolute dd-cfDNA measurements into a single actionable result designed to improve confidence in rejection assessment. Published data demonstrate enhanced specificity and PPV (rule-in performance) compared with either metric alone.1 Utilizing the Combination Model Score alongside the relative and the absolute metrics enhances the detection of allograft injury and monitoring organ transplant health, which can ultimately help clinicians make more informed patient management decisions.
Key Areas of Evaluation:
- Detection and classification of rejection
- Longitudinal dd-cfDNA trends
- Outcomes in DSA-positive patients
- Correlation with biopsy and clinical decision-making
- Graft outcomes and treatment response
- Early access to GraftAssure™ Combination Model Score
Benefits to Your Program
Participating centers gain direct access to the tools and evidence needed to move toward faster, more economical in-house dd-cfDNA testing.
Evaluate the GraftAssureCore™ Laboratory Developed Test
Assess iMDx’s dd-cfDNA testing service alongside your existing send-out workflows during Part 1.
A pathway to in-house testing
Part 2 offers eligible sites an optional transition to in-house testing following FDA authorization.
Access to GraftAssure™ Combination Model Score
Experience the clinical differentiation from the novel algorithm, which combines the measurement of absolute and relative quantification
Real-world clinical evidence
Your longitudinal data contributes directly to the clinical case for advancing transplant monitoring.
Publication opportunities
Participating centers are positioned to contribute to scientific publications and presentations alongside leading transplant programs.
Ready to learn more?
Request the full protocol, eligibility criteria, and onboarding details.
Study Design at a Glance
The registry follows patients longitudinally and cross-sectionally, collecting dd-cfDNA data at scheduled intervals and as clinically indicated to reflect real-world practice.
Type
Observational, prospective, multi-center registry
Patients
Up to 5,000 kidney transplant recipients
Sites
Up to 50 transplant centers
Duration
>3-year enrollment (Potential for longer follow-up)
Simple Path to Participation
How It Works:
- Submit interest form
- Execute confidentiality agreement and review protocol
- Complete site qualification
- Initiate participation
Participation is designed to integrate with standard clinical workflows, with options for centralized testing and potential transition to on-site testing.
What Sites Contribute:
- dd-cfDNA results
- Longitudinal patient data
- Relevant clinical context
All data collection follows IRB-approved protocols and applicable privacy standards.
Contribute to the Future of Transplant Diagnostics
Participation in the GALACTIC Registry enables transplant centers and laboratories to contribute to large-scale evidence generation and collaborate in advancing dd-cfDNA research.
Multi-Center
Participation in multi-center research
Evidence Development
Contribution to real-world evidence development
Scientific Collaboration
Opportunities for scientific collaboration and publication
Transplant Network
Engagement with a network of transplant programs
Interested in learning more?
Connect with the iMDx study team to receive the full protocol, eligibility criteria, and onboarding information.
