IMDx's GraftAssure CM-Score Outperforms Standard dd-cfDNA Metrics in Kidney Transplant Rejection Testing — Insight Molecular Diagnostics Inc. (iMDx)

Event summary

IMDx's GraftAssure CM-Score demonstrated superior diagnostic performance compared to single-metric dd-cfDNA in kidney transplant rejection testing, with a positive predictive value (PPV) of 81% and a negative predictive value (NPV) of 91%.
The study validating the CM-Score was published in the American Journal of Transplantation on June 11, 2026, and involved 106 rejections and 308 non-rejections.
IMDx has initiated the GALACTIC registry study to prospectively validate the CM-Score's impact on clinical decision-making and long-term patient outcomes.
The company is seeking FDA marketing authorization for its GraftAssureDx IVD kit, aiming to enable local transplant center laboratories to perform tests in-house.

The big picture

IMDx's GraftAssure CM-Score represents a significant advancement in transplant diagnostics, potentially transforming the way kidney transplant rejection is monitored. The superior performance of the CM-Score over traditional dd-cfDNA metrics could lead to more accurate and timely clinical decisions, improving patient outcomes. This development aligns with broader industry trends towards decentralized, faster, and more affordable diagnostic testing, positioning IMDx as a key player in the evolving landscape of transplant care.

What we're watching

Regulatory Approval: Whether IMDx can secure FDA marketing authorization for the GraftAssureDx IVD kit, enabling broader clinical adoption.
Clinical Adoption: The pace at which transplant centers adopt the GraftAssure CM-Score for guiding biopsy decisions and managing immunosuppression.
Market Disruption: How IMDx's shift towards in-house testing at local transplant centers will impact the competitive landscape of transplant diagnostics.