Second Study Affirms Superiority of iMDx GraftAssure Assay’s Proprietary dd-cfDNA Combination Model Score

Core Insights - Insight Molecular Diagnostics Inc. (iMDx) has published a new peer-reviewed study indicating the potential superiority of its GraftAssure assay technology for kidney transplant rejection testing [1][2] - The study demonstrates that donor-derived cell-free DNA (dd-cfDNA) levels correlate with transplant rejection activity, supporting the commercialization of GraftAssure technology [5][9] Study Details - The study, published in Transplant International, involved 249 patients who underwent kidney transplant biopsies, comparing dd-cfDNA measurements with histopathology-derived rejection indices [2][4] - Findings revealed that dd-cfDNA levels increased with histological evidence of graft inflammation, particularly in microvascular inflammation and antibody-mediated rejection [5][6] GraftAssure Technology - The GraftAssure Combination Model (CM)-score combines relative and absolute measurements of DNA fragments, showing a strong correlation with rejection indices, thus indicating its reliability in measuring biological signals in kidney transplantation [6][7] - The CM-score outperformed traditional measures, achieving a positive predictive value exceeding 80%, which is a significant improvement from the approximately 50% seen in existing literature [8][10] Market Potential - iMDx aims to deliver an industry-leading molecular diagnostic test kit in 2026, targeting the $2 billion-plus market for regulated transplant rejection testing [3][12] - The company’s strategy focuses on democratizing access to organ health testing for kidney transplant patients, enhancing clinical decision-making [3][13]