- iMDx's (IMDX, Financial) digital PCR test shows equivalence with current NGS-based kidney transplant rejection tests, reinforcing market competitiveness.
- The company aims for a market opportunity of $1 billion for transplant rejection testing, with a commercial launch targeted for 2026.
- Study validated across 96 patients, further data to be presented at the ESOT Congress in London.
Insight Molecular Diagnostics, known as iMDx (Nasdaq: IMDX), has reported promising results from a comparative study involving its digital PCR-based GraftAssureIQ test for kidney transplant rejection. Conducted at University Hospital Heidelberg, the study included 96 kidney transplant patients and demonstrated that the digital PCR approach delivers results equivalent to those of the current next-generation sequencing (NGS) platforms.
The findings underscore the digital PCR technology's enhanced analytical sensitivity in detecting donor-derived cell-free DNA (dd-cfDNA) even in low concentrations. This critical development potentially positions iMDx to make significant strides in the kidney transplant rejection testing market, estimated at $1 billion. The company plans for a commercial rollout in 2026 following anticipated regulatory approval.
iMDx will present extended results from the study at the European Society of Organ Transplantation (ESOT) Congress in London from June 29 through July 2. As part of its strategic approach, the company is engaging key opinion leaders and showcasing its innovations to further substantiate its market readiness and capability in transplant rejection diagnostics.
