Insight Molecular Diagnostics launches 5,000-patient registry study

Insight Molecular Diagnostics Inc. (NASDAQ: IMDX) announced the launch of a multi-center registry to collect real-world data on kidney transplant rejection testing across 5,000 patients over three years.

The Nashville-based company said the registry will span at least 25 medical centers and is expected to collect approximately 50,000 samples to support its donor-derived cell-free DNA assay for detecting organ rejection. The study aims to assess the clinical utility of the company's combined score algorithm that measures both percent and total donor-derived cell-free DNA.

The registry will also evaluate what the company calls "the Berlin protocol," an accelerated testing approach for high-risk patients, particularly those with new donor-specific antibodies.

"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," said CEO Josh Riggs.

The announcement follows several developments for the company in 2025. In January, iMDx achieved claims expansion for dd-cfDNA testing in CLIA certified labs for certain high-risk patients. In May, the Centers for Medicare & Medicaid Services increased its reimbursement rate for the company's GraftAssureCore test to $2,753 per result.

Data presented at the World Transplant Congress in August showed improved positive predictive value for graft rejection using the company's assay, according to the press release.

The company currently offers GraftAssureCore as a laboratory-developed test performed at its Nashville facility, while developing GraftAssureDx as an in vitro diagnostic kit that it intends to submit for FDA authorization in 2025.

CFO Andrea James said the company expects to execute the registry alongside planned commercial activity at its Nashville laboratory while maintaining financial discipline.

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