Insight Molecular Launches 5,000-Patient Registry To Advance Kidney Transplant Rejection Test

Insight Molecular Diagnostics, Inc. (NASDAQ:IMDX), ("iMDx"), today announced a positive strategic update and novel registry that will serve to gather real-world data on patient experiences and outcomes regarding its

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 (1)(2).

"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," said CEO Josh Riggs. "After sampling, we expect that most centers in the registry will want to convert to in-house testing, after regulatory clearance, when it makes sense for them."

"We expect to roll out this registry alongside our planned accelerated commercial activity and revenue generation at our Nashville lab," said iMDx CFO Andrea James. "Executing on our growth strategy while also exhibiting strong capital stewardship and financial discipline remain a top priority."

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 (PPV) for graft rejection, generating fewer false positive results, and reducing unnecessary invasive biopsies for patients.

"We have demonstrated two critical clinical innovations over the past year," said Chief Science Officer Dr. Ekke Schuetz. "The first is what we call the Berlin Protocol for testing frequency of certain high-risk patients, which are those with new donor-specific antibodies, and the second is our use of an algorithmic approach to both absolute and relative quantities of dd-cfDNA to improve biopsy yields."

The company seeks to deliver a best-in-class molecular diagnostic test kit, to expand and improve testing access for kidney transplant patients, which iMDx anticipates will deliver new value in the estimated $1 billion addressable market for transplant rejection testing.