Insight Molecular Diagnostics (Nasdaq: IMDX) is making headlines at the 2025 World Transplant Congress with late-breaking clinical data that could redefine how transplant physicians predict and manage kidney graft rejection. The company unveiled results validating a new approach to measuring donor-derived cell-free DNA (dd-cfDNA), showing a dramatic improvement in diagnostic accuracy through a novel combined score.
“Putting an assay in the hands of transplant physicians that helps to distinguish the cause of suspected organ damage, as rejection versus other common pathologies, with high and unprecedented rule-in and retained high rule-out power, makes our GraftAssure dd-cfDNA combination assay an exceptionally useful biomarker for the daily clinical challenges after kidney transplantation,” said iMDx Chief Science Officer Prof. Dr. Ekkehard Schuetz.
CEO Josh Riggs emphasized the broader impact of the findings, “Accuracy matters. These data show that diagnostic accuracy can be improved by combining two of our assays together into one score. We congratulate the researchers on the presentation of this data and are working to bring this innovation into our CLIA lab and into our research-use-only and regulated clinical kitted product pipeline.”
The study, which analyzed 403 samples across five clinical cohorts, introduces a digital PCR-based assay that merges both relative (percentage) and absolute (copies/mL) dd-cfDNA metrics into a single score. This integrated model significantly enhances the assay’s positive predictive value (PPV), reaching 79% at a 25% rejection prevalence, well above the typical 48% PPV seen with standalone measurements. At the same time, it retains a high negative predictive value (NPV) of 93%. The combined model was also the only method capable of distinguishing all types of rejection from non-rejection-related pathology.
iMDx’s digital PCR platform provides precise absolute measurements, an advantage that contributes to greater test reliability. The technology is already available through GraftAssureCore (a Medicare-reimbursed laboratory developed test) and GraftAssureIQ (a research-use-only kit). The company is also developing GraftAssureDx, which will be a regulated clinical kit intended for in-house hospital testing.
These advances support iMDx’s strategic positioning in the $1 billion transplant diagnostics market, with its GraftAssure™ product family poised for commercial growth. The company plans to evaluate the combined score further in its ongoing FDA study.
To extend the conversation beyond the conference, iMDx will host a virtual Key Opinion Leader (KOL) event on Friday, August 15, at 4:00 PM ET. Dr. Anthony Langone, Associate Professor at Vanderbilt University and national principal investigator of the company’s kidney transplant monitoring trial, will share insights on dd-cfDNA’s role in patient care and the benefits of enabling in-house testing with iMDx’s kitted products.
The event will also feature commentary from the iMDx leadership team on the company’s commercialization strategy and upcoming diagnostic offerings. A live Q&A will follow.
About Insight Molecular Diagnostics Inc.
Insight Molecular Diagnostics Inc., or iMDx, formerly Oncocyte Corp. (OCX), is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes.
iMDx™, GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, and VitaGraft™ are trademarks of Insight Molecular Diagnostics Inc.
Insight Molecular Diagnostics (Nasdaq: IMDX) moved its headquarters from Irvine, Calif., to Nashville, Tenn., in June 2025. The company’s new NASDAQ symbol became effective June 18. Investors may visit https://investors.imdxinc.com/ for more information.
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The post iMDx Presents Breakthrough Kidney Transplant Data at World Transplant Congress, Setting New Benchmark for Graft Rejection Prediction appeared first on PRISM MarketView.
