- American Journal of Transplantation publishes public pre-proof showing novel CM-score superior to either fractional or absolute measurement of dd-cfDNA alone
- GraftAssure™ assay doubles reliability of positive results in screening cohort
- In for-cause testing of kidney transplant patients, the positive predictive value using the CM-Score increased to greater than 80%
NASHVILLE, Tenn., June 11, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today 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.
“We believe that putting an assay in the hands of transplant physicians that can help 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 model score an exceptionally useful new tool for the daily clinical challenges after kidney transplantation,” said iMDx Chief Science Officer Prof. Dr. Ekkehard Schuetz.
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