iMDx Prepares for U.S. Commercial Launch of GraftAssureDx as Clinical Trial Nears Completion

Core Insights - Insight Molecular Diagnostics Inc. (iMDx) is preparing for its FDA submission of the GraftAssureDx™ test kit, with 95% of the submission work completed, including product design and technical transfer to manufacturing [3][4][7] - The company aims to enhance organ health testing for kidney transplant patients, targeting a market exceeding $1 billion for transplant rejection testing [2][7] - iMDx is also advancing its regulatory submissions in Europe, expecting to submit for CE mark and EU IVDR in the first half of 2026 after successful audits [4][7] Regulatory Submission Progress - The FDA submission for GraftAssureDx™ is nearly complete, with remaining tasks focused on quality control for newly developed software [3][4] - iMDx has made significant progress in regulatory compliance, positioning itself for market access in Europe following successful audits by TÜV SÜD [4][7] Market Engagement and Expansion - iMDx has engaged 20 global transplant centers, including its first Canadian site, to utilize GraftAssure™ technology [6][7] - The company is driving clinical community engagement through pilot programs and a novel registry, with 17 U.S. transplant centers planning to send samples in 2026 [5][10][7] Clinical Innovation and Research - The GraftAssureCore registry study aims to establish the clinical utility of dd-cfDNA testing, with a target of engaging 50 U.S. transplant centers [9] - iMDx's technology quantifies donor-derived cell-free DNA (dd-cfDNA), which is recognized as a reliable biomarker for transplant rejection [11]