iMDx’s GraftAssure Shows High Concordance with NGS in Kidney Transplant Monitoring
Event summary
- iMDx’s GraftAssure demonstrated 99.2% agreement with a leading NGS-based dd-cfDNA assay in kidney transplant rejection risk assessment.
- GraftAssure’s reference change value (RCV) was 41% at a median of 0.17% dd-cfDNA, enabling more precise longitudinal assessments.
- The study was published in Clinical Chemistry on June 16, 2026, and will be presented at the American Transplant Congress from June 20 to June 24, 2026.
- iMDx aims to seek FDA marketing authorization for its GraftAssureDx kit to enable local transplant center laboratories to run tests.
- GraftAssure leverages Bio-Rad’s QX600 droplet digital PCR (ddPCR) system, offering higher analytical sensitivity than NGS technologies.
The big picture
iMDx’s GraftAssure is positioned to disrupt the transplant monitoring market by offering a more precise, localized testing solution. The high concordance with NGS assays, combined with superior analytical sensitivity, could drive broader adoption of dd-cfDNA testing in routine clinical practice. The company’s strategy of enabling in-house testing at transplant centers aligns with industry trends toward decentralized diagnostics and faster result delivery.
What we're watching
- Regulatory Progress
- Whether iMDx can secure FDA marketing authorization for GraftAssureDx and expand its regulatory approvals in the EU.
- Market Adoption
- The pace at which transplant centers adopt GraftAssure for local testing, potentially disrupting the centralized lab model.
- Technological Edge
- How iMDx’s digital PCR technology will compete against established NGS-based assays in terms of sensitivity and cost-effectiveness.
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