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GlobeNewswire·

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

  • GraftAssure technology adoption expanded to 20 global transplant centers by year-end 2025, including the first Canadian site.
  • The FDA IVD approval application for GraftAssureDx is 95% complete with full submission expected in the coming weeks following minor software quality control adjustments.
  • UK CE mark & EU IVDR submissions are accelerated to the first half of 2026 after successful TÜV SÜD ISO 13485 stage 1 & 2 audit completions in Q4 2025.
  • The GraftAssureCore kidney registry saw strong clinical engagement with 17 U.S. transplant centers planning to send samples in 2026.
  • Management will attend meetings in San Francisco during "JPM Week" from January 12 to 15, 2026.
  • iMDx aims to engage 50 U.S. transplant centers to evaluate the clinical utility of its combined score using two independent dd-cfDNA measurements.
  • GraftAssureCore is a CLIA-certified lab-developed test previously known as VitaGraft, while GraftAssureIQ remains a research-use-only kit.
  • The company operates under a partnership with Bio-Rad to support domestic & global demand for in-house post-transplant management.