Insight Molecular Diagnostics' GraftAssure Assay Shows Superiority
Insight Molecular Diagnostics Inc. announced the publication of an article in the American Journal of Transplantation, asserting the statistical superiority of its GraftAssure Combination Model (CM)-score for transplant rejection monitoring. The CM-score, which combines relative and absolute measurements of donor-derived cell-free DNA, demonstrated superior diagnostic performance, significantly improving the positive predictive value to 81% while retaining a high negative predictive value of 91%. This data supports the company's strategy to commercialize its GraftAssure technology, aiming to provide more affordable and faster in-house testing, and is a step towards FDA marketing authorization for its GraftAssureDx kit.
Key Highlights
- GraftAssure Combination Model (CM)-score showed statistical superiority over single-metric dd-cfDNA in transplant rejection monitoring.
- CM-Score retained a high Negative Predictive Value (NPV) of 91% (89%–93%).
- CM-Score significantly improved Positive Predictive Value (PPV) to 81% (72%–89%; P<0.0001).
- Diagnostic performance was validated in 81 rejections and 282 non-rejections, compared to 11 published cohorts.
- Company initiated prospective clinical validation via its GALACTIC registry to confirm findings.
- iMDx is seeking FDA marketing authorization for its GraftAssureDx in vitro diagnostic (IVD) kit.
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