GraftAssure CM-Score Raises PPV to 81% and Retains 91% NPV in Kidney Transplant Screening
IMDX•Insight Molecular’s GraftAssure CM-Score boosted positive predictive value to 81% and retained a 91% negative predictive value in a cohort of 106 rejections and 308 non-rejections. The assay outperformed single-metric dd-cfDNA in derivation (81 rejections, 282 non-rejections) and clinical cohorts and prompted launch of a GALACTIC registry for validation.
1. Superior Diagnostic Performance Demonstrated
Insight Molecular’s GraftAssure CM-Score assay mathematically combines percentage and copies/mL measurements of donor-derived cell-free DNA to achieve a positive predictive value of 81% and negative predictive value of 91% in screening for kidney transplant rejection.
2. Validation across Derivation and Clinical Cohorts
Diagnostic performance was validated in 81 rejections and 282 non-rejections for derivation and in a full cohort of 106 rejections and 308 non-rejections, with decision curve analysis confirming statistically higher net benefit (P<0.003) versus single-metric dd-cfDNA.
3. Prospective Registry and Commercialization Strategy
The company has launched the GALACTIC registry for prospective clinical validation and is pursuing FDA marketing authorization for its in vitro diagnostic GraftAssure kit, aiming to enable local transplant centers to perform rapid, cost-effective dd-cfDNA testing.
