iMDx Study Validates GraftAssure Assay’s Superiority in Kidney Transplant Monitoring
Event summary
- Second study confirms GraftAssure’s proprietary dd-cfDNA Combination Model score outperforms percentage-only measures in kidney transplant rejection monitoring.
- Multi-center study included 249 biopsy-matched patients, reinforcing data from 2025 World Transplant Congress.
- GraftAssure’s CM-score showed strongest correlation with rejection indices, particularly for antibody-mediated rejection (AMR) and microvascular inflammation (MVI).
- iMDx aims to commercialize GraftAssureDx kit in 2026, targeting the $2B+ transplant rejection testing market.
The big picture
The study validates iMDx’s approach to kidney transplant monitoring, aligning with the industry shift toward continuous, non-invasive rejection assessment. The $2B+ transplant rejection testing market presents significant growth potential, particularly as localized testing becomes more critical for patient outcomes. iMDx’s proprietary technology could disrupt traditional diagnostic methods if successfully commercialized.
What we're watching
- Commercialization Timing
- Whether iMDx can deliver its industry-leading molecular diagnostic test kit by 2026 as planned.
- Market Differentiation
- How the proprietary Combination Model score will position GraftAssure against existing transplant rejection tests.
- Regulatory Pathway
- The pace at which iMDx advances GraftAssureDx through FDA submission and approval.
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