iMDx (Nasdaq: IMDX) announced positive results from a head-to-head study comparing its flagship digital PCR-based dd-cfDNA test kit, GraftAssureIQ, with a commercially available NGS-based kit. The study, conducted by University Hospital Heidelberg, demonstrated equivalent performance between the two platforms in measuring dd-cfDNA in 96 kidney transplant patients. This data supports iMDx’s goal of commercializing its technology in the transplant rejection testing market.
This news is particularly important because it validates iMDx’s digital PCR approach as a viable alternative to the established NGS technology in transplant rejection diagnostics. This validation could open doors for broader adoption of digital PCR in this market, potentially offering advantages in cost, accessibility, and turnaround time for crucial diagnostic information. The study’s findings build confidence in iMDx’s platform as it prepares for commercial launch, offering a potentially competitive alternative to existing options.
The study directly compared two commercially available dd-cfDNA kits based on single nucleotide polymorphisms (SNPs): iMDx’s digital PCR-based GraftAssureIQ and an NGS-based kit. Results showed equivalent dd-cfDNA measurements between the two platforms across various biopsy-proven pathology categories. While confirming clinical interchangeability, digital PCR also exhibited improved analytical sensitivity, suggesting potential benefits in detecting low levels of dd-cfDNA. It should be noted that GraftAssureIQ is currently a research-use-only product. iMDx is developing GraftAssureDx, a separate IVD kit intended for clinical use, and is seeking regulatory authorization. Further data will be presented at the European Society of Organ Transplantation (ESOT) Congress.
This positive study data strengthens iMDx’s position as it moves toward commercialization of its transplant diagnostic technology. The demonstrated equivalence with existing NGS technology builds credibility and offers a potential market alternative. Further development of the clinical version, GraftAssureDx, along with continued data presentation and research collaborations, positions iMDx for potential growth in the transplant diagnostics market. An upcoming key opinion leader webinar with the national principal investigator of iMDx’s ongoing kidney transplant monitoring trial will provide further insights into the technology and its potential clinical impact.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
