iMDx Study Shows GraftAssure 99.2% Concordance with NGS and 0.04% Sensitivity
IMDX•iMDx’s GraftAssure digital-PCR test achieved 99.2% concordance with an NGS-based dd-cfDNA assay at the 0.5% rejection threshold and detected dd-cfDNA down to 0.04% versus 0.12–0.23% for NGS. The study found a reference change value of 41% at a median dd-cfDNA of 0.17%, enabling precise longitudinal graft monitoring and earlier intervention.
1. Head-to-Head Study Results
Insight Molecular Diagnostics published the first direct comparison between GraftAssure and an NGS-based dd-cfDNA assay, reporting 99.2% diagnostic agreement at the 0.5% clinical threshold and enhanced analytical sensitivity down to 0.04% versus 0.12–0.23% for NGS.
2. Analytical Precision and Reference Change Value
The study demonstrated a reference change value of 41% at a median dd-cfDNA level of 0.17% in stable graft patients, validating GraftAssure’s lower limit of quantification and enabling more precise longitudinal monitoring of transplant health.
3. Clinical and Regulatory Implications
These findings support clinical interchangeability of digital PCR and NGS platforms, advocate for in-house dd-cfDNA testing at transplant centers, and bolster iMDx’s upcoming EU regulatory submission for GraftAssure test kits.
4. Commercialization and Future Directions
iMDx plans to leverage GraftAssure’s analytical advantages to expand its market presence, showcase data at the American Transplant Congress, and pursue FDA authorization to enable faster, localized transplant rejection monitoring in the U.S.
