Insight Molecular Diagnostics announces results from test kit technology study

Insight Molecular Diagnostics (IMDX) announced results from a study evaluating its test kit technology in a head-to-head comparison with another commercially available test kit. The findings indicated equivalent measurements of donor-derived cell-free DNA, a molecular biomarker used to assess the risk of transplant rejection, between the two platforms studied. This data supports iMDx’s top priority of launching its first clinical molecular diagnostic test kit and capturing value in the estimated $1B transplant rejection testing market. In 2025 to date, iMDx is executing the key steps typically necessary to transition from product development to commercialization. The study was conducted by the University Hospital Heidelberg in Germany and represents the first direct comparison of two commercially available dd-cfDNA test kits based on single nucleotide polymorphisms. One test uses next generation sequencing, while the other – iMDx’s GraftAssure, now branded as GraftAssureIQ – uses digital polymerase chain reaction. Unlike sequencing-based approaches, digital PCR does not sequence DNA but instead precisely quantifies specific DNA targets in a sample.