NASHVILLE, Tenn., June 11, 2026
Insight Molecular Diagnostics, Inc. (Nasdaq: IMDX) announced that the American Journal of Transplantation has published new data highlighting the superior performance of its GraftAssure™ Combination Model (CM)-Score, a next-generation donor-derived cell-free DNA (dd-cfDNA) assay designed to improve the detection and monitoring of kidney transplant rejection. The study demonstrated that the CM-Score significantly outperformed traditional single-metric dd-cfDNA measurements, establishing a new benchmark for transplant rejection assessment. By combining both relative (percentage) and absolute (copies per milliliter) measurements of donor-derived DNA, the assay provided stronger diagnostic accuracy and improved confidence in identifying transplant rejection. The findings were initially presented as a late-breaking study at the World Transplant Congress 2025 and are expected to influence future transplant monitoring strategies.
Novel CM-Score Significantly Improves Diagnostic Performance
The newly developed GraftAssure CM-Score integrates two key dd-cfDNA biomarkers into a single analytical model, providing a more comprehensive assessment of transplant health than conventional methods. Validation across 81 rejection cases and 282 non-rejection cases demonstrated superior diagnostic performance compared with either dd-cfDNA percentage or absolute concentration alone. In a larger clinical cohort consisting of 106 rejection and 308 non-rejection cases, the CM-Score maintained a strong negative predictive value (NPV) of 91% while dramatically improving the positive predictive value (PPV) to 81%, compared with a weighted average PPV of approximately 54% reported in previously published studies. The improved rule-in capability enables physicians to identify transplant rejection more accurately while preserving the assay’s strong ability to rule out rejection, potentially reducing unnecessary biopsies and invasive procedures.
Potential to Transform Clinical Decision-Making in Transplant Care
The study findings support a broader shift in transplant medicine toward more precise and actionable molecular diagnostics. According to Insight Molecular Diagnostics, the GraftAssure assay advances dd-cfDNA testing beyond its traditional role as a rule-out tool and positions it as a comprehensive decision-support platform capable of both ruling in and ruling out rejection. The assay’s ability to distinguish rejection from other causes of organ injury may help clinicians make faster treatment decisions, optimize immunosuppressive therapy, and improve long-term graft survival. Researchers also noted that decision curve analysis showed significantly greater clinical benefit for the CM-Score compared with existing dd-cfDNA testing approaches, reinforcing its potential value in routine kidney transplant management.
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GALACTIC Registry to Advance Clinical Validation and Adoption
Building on these promising results, Insight Molecular Diagnostics has launched the GALACTIC Registry (GraftAssure Lowering Allograft rejeCTIon by Combination), a prospective clinical validation program designed to further evaluate the CM-Score’s impact on patient management and long-term transplant outcomes. The registry will assess how the assay influences biopsy decisions, treatment adjustments, and overall graft health across real-world clinical settings. The company is also pursuing FDA marketing authorization for future commercialization of GraftAssure diagnostic kits, which are intended to enable local hospital laboratories to perform transplant rejection testing in-house rather than relying on centralized reference laboratories. This decentralized testing approach aims to deliver faster results, improve patient access, and reduce healthcare costs. As transplant medicine continues to evolve, the GraftAssure CM-Score represents a significant advancement in precision diagnostics, with the potential to reshape how clinicians monitor and manage organ transplant recipients.
Source: IMDX press release
