IMDX World Transplant Congress Late-Breaking Data Potentially Sets New Bar for Predicting Graft Rejection in Kidney Transplant Patients

Core Insights - Insight Molecular Diagnostics (iMDx) announced two favorable oral abstracts, including a late-breaking study, to be presented at the World Transplant Congress from August 2 to 6, 2025, in San Francisco [1] Study Findings - The late-breaking study validated iMDx's novel approach to quantifying donor-derived cell-free DNA (dd-cfDNA), showing a positive predictive value (PPV) of 79% at a 25% rejection prevalence, significantly higher than the average 48% from published data [2] - The combined model of relative and absolute dd-cfDNA quantification was able to distinguish all types of rejection from non-rejection pathologies, indicating its dual utility in clinical decision-making [3][4] Clinical Implications - The improved PPV suggests that the dd-cfDNA combination model can serve as both a reliable tool to rule out organ rejection and a meaningful rule-in option, potentially changing the paradigm of dd-cfDNA testing [3] - iMDx's GraftAssure dd-cfDNA combination assay is positioned as an exceptionally useful biomarker for transplant physicians, addressing daily clinical challenges after kidney transplantation [4] Product Development - iMDx is working to bring the innovation into its CLIA lab and into its research-use-only and regulated clinical kitted product pipeline, enhancing diagnostic accuracy by combining two assays into one score [5] - The company is also developing GraftAssureDx and intends to seek regulatory authorization for clinical use, targeting the estimated $1 billion transplant rejection testing market [9] Upcoming Presentations - iMDx will present a second abstract at the World Transplant Congress, reaffirming dd-cfDNA as a noninvasive standard for predicting kidney transplant rejection, with the data selected for prominent discussion during the closing plenary session [6] Company Overview - iMDx, formerly known as Oncocyte Corp., is focused on democratizing access to novel molecular diagnostic testing to improve patient outcomes, with its GraftAssure product lines already achieving Medicare reimbursement [15][17]