iMDx Reports Strong Head-to-Head Data in Kidney Transplant Rejection Testing

Core Insights - Insight Molecular Diagnostics (iMDx) announced positive results from a study comparing its GraftAssureIQ test kit with another commercially available test kit, showing equivalent measurements of donor-derived cell-free DNA (dd-cfDNA) [1][3][5] - The company aims to launch its first clinical molecular diagnostic test kit, targeting the estimated $1 billion transplant rejection testing market [2][15] - The study, conducted by the University Hospital Heidelberg, represents the first direct comparison of two commercially available dd-cfDNA test kits, one using next-generation sequencing (NGS) and the other using digital polymerase chain reaction (digital PCR) [4][5] Study Details - The study evaluated 96 kidney transplant recipients and demonstrated that both platforms provided consistent results, reinforcing the reliability of dd-cfDNA testing in routine transplant care [5][8] - Digital PCR showed improved analytical sensitivity compared to NGS, suggesting potential advantages in detecting dd-cfDNA in low quantities [3][5] - Extended data from the study will be presented at the upcoming European Society of Organ Transplantation (ESOT) Congress in London [7][8] Product Development - GraftAssureIQ is currently a research-use-only kit, while iMDx is developing GraftAssureDx for clinical use and intends to seek regulatory authorization [6][16] - The company has transitioned its headquarters from Irvine, California, to Nashville, Tennessee, and its NASDAQ symbol changed to IMDX [14] - iMDx's transplant diagnostics include GraftAssureCore, which is a lab-developed test currently reimbursed by CMS [15]