Insight Molecular Diagnostics (iMDX) (NASDAQ: IMDX) has announced a positive strategic update and novel registry to gather real-world data on patient experiences and outcomes concerning its flagship kidney transplant rejection assay.
According to iMDX, 5,000 patients will be enrolled into the registry across 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 (1)(2).
In a statement, Josh Riggs, CEO of iMDX, commented, “Following several successful milestones achieved by the company so far in 2025, we are very pleased to announce another positive development—a designated registry that we believe will serve as a supportive data repository referencing 5,000 patients. We’re excited to work with the clinical community as they explore how to draw on the data and use the methodologies that we’ve advanced over the past year.”
Andrea James, CFO of iMDX, added, “We expect to roll out this registry alongside our planned accelerated commercial activity and revenue generation at our Nashville lab. Executing on our growth strategy while also exhibiting strong capital stewardship and financial discipline remain a top priority.”
