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NASHVILLE - Insight Molecular Diagnostics, Inc. (NASDAQ:IMDX), a $71 million market cap diagnostics company, announced Monday the creation of a multi-center registry that will collect data from 5,000 kidney transplant patients to evaluate its organ rejection diagnostic test. According to InvestingPro analysis, the company maintains a strong liquidity position with assets exceeding short-term obligations, though its overall financial health score indicates challenges ahead.
The registry, which will span at least 25 centers over three years, aims to gather approximately 50,000 samples to assess iMDx’s assay that measures donor-derived cell-free DNA (dd-cfDNA), a biomarker for transplanted organ rejection. While the company’s revenue grew over 300% in the last twelve months, InvestingPro data shows it’s currently burning through cash with an EBITDA of -$22.8 million.
The study will evaluate the company’s combined score algorithm that incorporates both percentage and total dd-cfDNA measurements. It will also assess the utility of the "Berlin protocol," which involves accelerated testing for patients considered at high risk for organ rejection.
"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 in the press release.
The registry announcement follows several developments for iMDx in 2025, including claims expansion for dd-cfDNA testing in January and an increased Medicare reimbursement rate of $2,753 per test in May.
According to the company, data presented at the World Transplant Congress in August showed improved positive predictive value for graft rejection with fewer false positives, potentially reducing unnecessary biopsies.
iMDx is developing a diagnostic test kit for the kidney transplant market, which it estimates at $1 billion. The company currently offers GraftAssureCore, a laboratory-developed test performed at its Nashville facility, and is working on GraftAssureDx, an in vitro diagnostic kit it plans to submit for FDA authorization this year.
The company relocated its headquarters from Irvine, California, to Nashville, Tennessee, in June 2025.
In other recent news, Insight Molecular Diagnostics has been in the spotlight with several noteworthy developments. The company announced that its flagship transplant rejection test kit has shown equivalent performance to a commercially available alternative. This was determined through a study conducted by University Hospital Heidelberg in Germany, which evaluated 96 kidney transplant recipients. The study found that Insight Molecular Diagnostics’ digital PCR-based test produced results consistent with next-generation sequencing kits across all biopsy-proven pathology categories.
Additionally, Needham has reiterated a Buy rating on Insight Molecular Diagnostics, maintaining a price target of $4.25. The research firm highlighted positive momentum in the company’s product launches and clinical development. Specifically, Needham noted the progress of the GraftAssureIQ research use only test, as the company continues to sign on transplant centers. Insight Molecular Diagnostics is planning a mid-2026 launch of its GraftAssureDx Kidney kitted test, pending FDA clearance.
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