IMDX Supports AST and ASHI STAR Working Group’s Call for Decentralized Transplant Monitoring

NASHVILLE, Tenn., Jan. 13, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today congratulated the STAR working group on its position paper in theAmerican Journal of Transplantationin recognizing the need for decentralized organ health testing in the global transplant community.

Specifically, the publication states, “High-quality, standardized decentralized dd-cfDNA testing is the essential prerequisite for conducting real-world evidence-generating multicenter studies to establish the appropriate context of use for this promising assay.”

“We completely agree with the working group’s conclusion. It’s high time that we give transplant centers the tools that they need to build guidelines and manage patients themselves,” iMDx CEO Josh Riggs said. “Such a full-throated call for access to test kits is great for us as an indicator of pent-up industry demand for what we are building. We are also pleased with the positive details throughout the paper regarding absolute quantification and the potential value of having onsite testing. This conclusion directly aligns with iMDx’s strategy and is supportive of our flagship GraftAssure family of assays.”

STAR is a joint group between the American Society of Transplantation (AST) and the American Society for Histocompatibility and Immunogenetics (ASHI). AST and ASHI are the professional societies representing the clinicians and laboratories that serve the transplant community. STAR stands forSensitization inTransplantation:Assessment ofRisk. One of STAR’s working groups focuses on dd-cfDNA, and this publication is a conclusion from that group.

“We congratulate the STAR working group’s great position paper on the analytical validity of dd-cfDNA methods,” iMDx Chief Science Officer Dr. Ekkehard Schuetz said. “It is clearly articulated that the future is a decentralized high-quality assay with transparent quality control, which will facilitate broader, faster, and more cost-effective access to dd-cfDNA as the most promising rejection biomarker that it is.”

iMDx seeks to deliver the industry-leading molecular diagnostic test kit for clinical use that decentralizes access to organ health testing for kidney transplant patients. The company expects that enabling decentralized testing will deliver new value in the roughly $1 billion-plus addressable market for kitted transplant rejection testing. iMDx believes that decentralizing access to transplanted organ rejection testing will bring care closer to the patient and help hospitals to operate more sustainably, as well as create a rapidly growing, high-margin, recurring business model.

Link to paper:https://www.sciencedirect.com/science/article/pii/S1600613525029508

iMDx’s flagship transplant testing technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). The company’s scientists in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker of transplant rejection. iMDx is commercializing this technology using a market-disruptive business strategy. Under the GraftAssure™ brand, iMDx’s transplant diagnostics include the following:

Insight Molecular Diagnostics is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. Investors may visit https://investors.imdxinc.com/ for more information.

GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight Molecular Diagnostics Inc.

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