Announcement • Jun 17
Insight Molecular Diagnostics Inc. Announces Favorable Head-To-Head Data On Imdx's Graftassure With Competing NGS Assay Published In Clinical Chemistry Insight Molecular Diagnostics Inc. announced the online publication of a favorable article in Clinical Chemistry, the premier, peer-reviewed scientific publication of the Association for Diagnostics & Laboratory Medicine. The article highlights the concordant performance between iMDx's digital-PCR-based transplant monitoring test, GraftAssureTM, and a competing next-generation-sequencing-based assay kit that is sold outside of the U.S. The publication titled,’High Concordance between ddPCR- and NGS-Based Quantification of Donor-Derived Cell-Free DNA percentage after Kidney Transplantation,’ concludes:’This study provides the first comparison of two established dd-cfDNA testing methods and demonstrates excellent diagnostic agreement. These findings support flexibility in assay selection based on availability and cost, supporting the integration of dd-cfDNA testing into routine [clinical] practice.’ GraftAssure demonstrated 99.2% agreement with a leading next-generation sequencing (NGS)-based donor-derived cell-free DNA (dd-cfDNA) assay at the clinical threshold of 0.5% for the assessment of kidney transplant rejection risk. The reference change value (RCV) describes the minimally significant difference between two serial measurements in one individual. The RCV of GraftAssure was assessed to be 41% at an unprecedentedly low median of 0.17% dd-cfDNA, in 55 samples from 18 patients without any evidence of graft dysfunction. This low RCV enables more precise longitudinal assessments, which has the potential to allow for earlier interventions compared to what can be achieved with older technologies. The RCV could not be calculated for the comparator NGS assay, since over 50% of the dd-cfDNA measurements were below its lower limit of quantification in the 55 samples used. The analytical validation of GraftAssure demonstrated a lower limit of quantification of 0.04%, which is several folds lower compared to NGS technologies, which are published to be between 0.12%-0.23%. GraftAssure also enables the precise quantification of the absolute dd-cfDNA content with a lower limit of quantification of 4 copies/mL of patient plasma, empowered by the strength of the primarily quantitative droplet digital PCR technology. This is particularly important for the use in combination with percentage in iMDx's GraftAssure Combination Model Score(1, 2). ‘It is exciting to see how the development of GraftAssure assay has reached a quality that believe is poised to improve patient care when using dd-cfDNA. GraftAssure leverages Bio-Rad's QX600 droplet digital PCR (ddPCR) system. Digital PCR is a more recently developed and primarily quantitative analytical technology, with high inherent precision and accuracy. In contrast to NGS, digital PCR technologies have been developed for precision quantification of DNA and are considered as’reference measurement procedure’ (ISO 17511-2020). The competing kitted assay for dd-cfDNA determination is available outside of the U.S. Several publications claim an equivalent clinical performance between this competing kitted assay and a similar leading lab-developed test available inside the U.S., (3, 4), which is the centralized dd-cfDNA assay provided by this same competitor. The data from this study and the potential impact of a dd-cfDNA assay that has shown head-to-head correlation to NGS while offering more precise analytics, will be shared at the American Transplant Congress in Boston from June 20 to June 24, 2026. Announcement • Jun 13
Imdx Graftassure Assay Sets New Standard in Screening Kidney Transplant Patients Per American Journal of Transplantation Insight Molecular Diagnostics Inc. announced an online published article in the American Journal of Transplantation asserting statistical superiority of the company’s flagship GraftAssure transplant rejection monitoring assay. IMDx's newly developed GraftAssure Combination Model (CM)-score mathematically combines the relative (percentage, or %) and absolute (copies per milliliter, or cp/mL) measurements of DNA fragments from the transplanted organ. In this study, the tight correlation between the novel GraftAssure CM-score and rejection suggests that the assay is reliably assessing rejection in kidney transplantation versus non-rejection. This data was first presented as late breaking at the World Transplant Congress in August 2025. The data and its implications for the future of transplanted organ rejection testing will be shared at the American Transplant Congress in Boston from June 20 to June 24, 2026. Key takeaways for the scientific and clinical communities: The CM-Score was derived from a random sub-cohort and has superior diagnostic performance compared to single-metric dd-cfDNA. Diagnostic performance was validated in 81 rejections and 282 non-rejections and compared to 11 published cohorts. For all evaluations, CM-Score was better than dd-cfDNA in copies/mL, which was better than dd-cfDNA in percent. The CM-Score retained a high NPV of 91% (89%–93%), while significantly improving PPV to 81% (72%–89%; P<0.0001, prevalence: 25%) in the full clinical cohort of 106 rejections and 308 non-rejections, compared to published values (weighted average NPV: 90% (89%–92%); PPV: 54% (52%–55%), N=6,536). Decision curve analysis yielded a significantly higher net benefit for the CM-Score (P<0.003). This study establishes that the CM-Score has superior diagnostic performance compared to single-metric dd-cfDNA. The company has initiated prospective clinical validation via its GALACTIC registry to confirm these findings, to verify the impact of these findings on clinical decision-making, and to evaluate long-term patient outcomes when using the CM-Score to guide biopsy decisions and immunosuppression management. (The company’s GALACTIC registry study (GraftAssure Lowering Allograft rejeCTIon by Combination) is designed to drive clinical adoption and build a scientific case for the Combination Model score (CM-score)). Contextual overview for investors: iMDx is at a pivotal stage in commercializing its GraftAssure™ technology, which iMDx expects to be an industry-transforming transplanted organ rejection monitoring test. The company aims to deliver proven, more affordable, faster tests that can be run in-house at local transplant center laboratories. iMDx has designed a molecular test that it can sell as a test kit to help enable transplant center laboratories to run tests locally and deliver critical test results far more quickly than the current send-out tests. The company is now seeking FDA marketing authorization to sell these kits to transplant centers in the U.S. Over time, iMDx sees three potential paradigm shifts in transplanted organ health monitoring and this latest data published in the American Journal of Transplantation directly supports the second and third shifts: Bringing testing closer to the patient: The first is a shift in where donor-derived cell-free DNA (dd-cfDNA) testing is performed – migrating out of centralized reference laboratories and into hospital-based laboratories capable of delivering results locally. (As a reminder, dd-cfDNA is an established biomarker for assessing the health of a transplanted organ through a simple blood draw.) Expanding the clinical role of dd-cfDNA: The second is the growing potential for dd-cfDNA testing, powered by digital PCR technology, to enable earlier detection of allograft injury, longitudinal monitoring of transplant health, and assessment of response to emerging anti-rejection therapies. Advancing from rule-out to comprehensive decision support: The third is a transition from the current rule-out-biopsy testing paradigm toward a comprehensive rule-out and rule-in approach, enabled by GraftAssure’s ability to measure both dd-cfDNA percentage and absolute, or true, concentrations as copies per milliliter of plasma. MDx Transplant Products and Product Candidates in Development, 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: GraftAssureCore – The company’s laboratory-developed test (LDT), currently reimbursed by CMS and performed at iMDx’s CLIA-certified laboratory in Franklin, Tennessee.
GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for non-clinical applications. GraftAssureDx – The in vitro diagnostic (IVD) kit currently in development for use in clinical decision-making. 
