Insight Molecular Diagnostics announces novel registry database

Insight Molecular Diagnostics (IMDX) announced a strategic update and novel registry that will serve to gather real-world data on patient experiences and outcomes regarding its flagship kidney transplant rejection assay. The company expects to enroll 5,000 patients into the registry across at least 25 centers, over three years. Data analyzed from the registry is intended to support the clinical utility of the company’s unique assay that utilizes a “combined score” algorithm, as well the effectiveness of an accelerated monitoring protocol for certain high-risk patients. Both data points are logical follow ups to recently published favorable data regarding iMDx’s signature assay. The registry announcement follows several key developments from both iMDx and the broader industry. In January 2025, iMDx announced that it had achieved claims expansion for dd-cfDNA testing in CLIA certified labs for certain high-risk patients, and in May 2025, the Centers for Medicare & Medicaid Services (CMS) increased its reimbursement rate for GraftAssureCore to $2,753 per result. In addition, late-breaking data presented at the World Transplant Congress in August 2025 show significantly improved positive predictive value for graft rejection, generating fewer false positive results, and reducing unnecessary invasive biopsies for patients.