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Highlights

  • iMDx enrolled the first patient in its GraftAssureDx clinical trial and is actively recruiting additional participants.

  • The trial now includes 10 leading transplant centers, up from five previously listed.

  • The study aims to assess the GraftAssureDx test for detecting kidney transplant rejection, targeting a $1 billion market.

Insight Molecular Diagnostics, Inc. (Nasdaq:IMDX) announced that it has begun actively enrolling patients in its clinical trial to evaluate GraftAssureDx, its next-generation kitted transplant rejection test. Last week, the first patient was enrolled, marking a key milestone in the study. The official clinical trial listing now identifies 10 leading transplant centers, double the number previously named.

The observational trial is designed to determine whether the GraftAssureDx kitted test can effectively assess organ rejection in kidney transplant recipients. iMDx anticipates enrolling up to 125 patients and aims to complete the study by the end of 2025. The results of this trial are intended to support regulatory submissions for FDA authorization.

GraftAssureDx and the Product Pipeline
GraftAssureDx will be the third version in the GraftAssure family of assays. iMDx’s current offerings include GraftAssureCore, a laboratory-developed test (LDT) reimbursed by Medicare at $2,753 per result, and GraftAssureIQ, a research-use-only kitted assay available for non-clinical applications.

GraftAssureDx is being developed as an in vitro diagnostic (IVD) kit for clinical decision-making. The company plans to submit the test for FDA authorization in 2025, with the goal of providing a standardized, scalable test kit for transplant rejection monitoring. The trial will help validate the clinical utility of the kit and demonstrate its applicability in routine patient care.

Technology and Market Context
iMDx’s transplant testing technology measures donor-derived cell-free DNA (dd-cfDNA), a molecular biomarker established over the past decade as an indicator of transplant rejection. Scientists at iMDx in Germany and the U.S. have contributed to the foundational research that supports dd-cfDNA as a reliable biomarker.

The company’s GraftAssure™ portfolio represents a market-disruptive approach to transplant diagnostics. GraftAssureCore is performed at iMDx’s CLIA-certified laboratory in Nashville and is in the process of rebranding from its previous VitaGraft name. GraftAssureIQ is available for research purposes, while GraftAssureDx is under development to provide a kitted solution for clinical use, targeting the estimated $1 billion addressable market for transplant rejection testing.

About Insight Molecular Diagnostics
Insight Molecular Diagnostics, Inc., formerly Oncocyte Corp. (OCX), is a diagnostics technology company focused on improving patient outcomes through accessible molecular testing. iMDx leverages dd-cfDNA to provide quantitative insights into transplant rejection and aims to expand access to reliable, innovative diagnostics for transplant recipients worldwide.