IMDX Supports AST and ASHI STAR Working Group's Call for Decentralized Transplant Monitoring
Nashville, Tenn., January 13, 2026 - Insight Molecular Diagnostics Inc. (Nasdaq: IMDX), a leader in molecular diagnostics, has endorsed the STAR working group’s position paper published in the American Journal of Transplantation, highlighting crucial strategies for decentralized organ health testing within the transplant community.
Key Highlights of the Position Paper
The position paper emphasizes the necessity of high-quality, standardized decentralized dd-cfDNA testing. This testing is deemed vital for facilitating multicenter studies that can yield real-world evidence regarding the efficacy of assays like iMDx’s flagship GraftAssure™ family.
“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,”
CEO’s Insight on Decentralized Testing
Josh Riggs, CEO of iMDx, expressed full support for the working group’s conclusions. He stated, “It’s high time that we give transplant centers the tools that they need to build guidelines and manage patients themselves. 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.”
He further highlighted the alignment of these findings with iMDx’s strategy, particularly regarding the emphasis on absolute quantification and onsite testing capabilities.
About the STAR Working Group
The STAR working group, formed between the American Society of Transplantation (AST) and the American Society for Histocompatibility and Immunogenetics (ASHI), aims to assess risks associated with transplant sensitization. One key focus remains on dd-cfDNA, underscoring its importance in transplant monitoring.
Dr. Ekkehard Schuetz, Chief Science Officer at iMDx, reinforced the paper’s validation of dd-cfDNA methods, stating, “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.”
Market Opportunities for iMDx
Insight Molecular Diagnostics is poised to capitalize on a market exceeding $1 billion in potential revenue related to transplant rejection testing. The company believes that by decentralizing access to transplant rejection diagnostics, it can enhance patient care and contribute to more sustainable hospital operations.
This strategic move is expected to create a rapidly growing, high-margin, recurring business model for iMDx, in alignment with industry demand.
About Insight Molecular Diagnostics Inc.
Insight Molecular Diagnostics is committed to democratizing access to molecular diagnostic testing to enhance patient outcomes. Their GraftAssure™ product line includes:
- GraftAssureCore: A laboratory-developed test (LDT), currently reimbursed by CMS.
- GraftAssureIQ: A research-use-only (RUO) kit aimed at non-clinical applications.
- GraftAssureDx: An in vitro diagnostic (IVD) kit in development for clinical decision-making.