IMDX Submits GraftAssureDx for FDA Review and Reports Q4 2025 Results

NASHVILLE, Tenn., March 26, 2026(GLOBE NEWSWIRE)-- Insight Molecular Diagnostics Inc., iMDx, (Nasdaq: IMDX), today published the following letter to shareholders in conjunction with its fourth quarter results:

Fellow shareholders,

We are pleased to share that GraftAssureDx has become, to our knowledge, the first ever kitted dd-cfDNA assay to be submitted to the FDA for regulatory review. Our FDA submission this week represents the culmination of 12 years of clinical development and three years of highly focused technical product development.

We see many positive signals that the transplant community is ready for GraftAssureDx.

In the past three months, we have doubled the number of transplant centers interested in what we are building. We are now engaged with 37 centers in the U.S. and 11 internationally, through our research-use-only assay as well as through our registry study. The 37 centers that we are engaged with in the U.S. include 28 transplant centers that want to join our registry trial, which we discuss in more detail under “2026 goals.”

We are thrilled to be able to share such a significant improvement in market access since our last update. The 37 centers in the U.S. with which we are engaged representmore than 25% of all transplants performed annually in the United States. We look forward to engaging with more centers over the coming quarters as word continues to spread about the advantages of our technology.

We expect that our test kits will deliver new value in the roughly $2 billion addressable market for regulated transplant rejection testing. We believe we are delivering the right product to the right market, at the right time, and that we are in the first stages of a dramatic shift in patient management, positioning ourselves to lead.

It's clear to us that market demand for regulated and decentralized molecular testing is growing. At the same time, more head-to-head data has emerged showing the reliability of our GraftAssure technology in field, and new peer-reviewed publications are highlighting the benefits of our assay.

For the remainder of this letter, we will cover:

Looking forward, the FDA guides to a 150-day review process forde novosubmissions like ours, and therefore we continue to plan for an FDA-authorized product this year. To note, when the FDA has a question, it can stop the clock relative to its 150-day guidance. Consequently, our teams are working to anticipate and prepare for FDA reviewer questions so that we may respond quickly and remain on track in the review process.

We have made a review-ready submission with sufficient analytical data and clinical evidence to support that our assay is safe and effective for using the fractional measurement of dd-cfDNA to assess the likelihood of transplanted organ rejection.

As we’ve previously discussed, we will continue to collect clinical samples to add incremental claims associated with our assay including absolute measurements of dd-cfDNA (copies per milliliter) and our combination score (CM-score). Supplementary data collection is a standard practice in IVD submissions and does not affect the expected approval timeline of our initial submission.

We are grateful to our clinical trial partners for helping to advance the science of transplant patient management. We are also grateful for the support of Bio-Rad Laboratories, which not only invested in our equity for a fourth time in February, but also provided in-kind support and a team of scientists who worked tirelessly alongside us to support a timely FDA submission.

Finally, iMDx leadership is proud of its broader team’s ability to manage complexity and coordinate with multiple stakeholders, including our kit manufacturer, software vendor, the clinical trial sites, and our strategic partner, Bio-Rad.

We believe that 2026 represents our transition from a product development-stage company into a commercialization-stage company, and accordingly, we are making controlled investments in sales and marketing to support our kidney transplant assay. Our goals for 2026 include the following:

In February, at the Cutting Edge of Transplantation (CEoT) conference in Scottsdale, Ariz., a leading American transplant hospital presented its head-to-head study findings comparing our flagship organ transplant assay technology with a leading industry competitor providing centralized testing. In medical diagnostics, a head-to-head study is the highest level of comparison one can conduct, involving the same sample tested by two separate tests. The hospital’s independent conclusion was favorable for our assay, and the researcher presenting the data shared that his hospital seeks to implement in-house testing because of their assessment.

The above study represents thesecondhead-to-head comparison between GraftAssure and other technologies on the market. In June 2025, weannounced separate favorable head-to-head datathat was presented at the European Society of Organ Transplantation (ESOT) Congress in London as well as at the European Renal Association (ERA) meeting. Notably, the study showed high diagnostic concordance between the two assays for rejection.

We expect more head-to-head data to emerge as more researchers and institutions engage and begin to utilize our technology. The emergence of this data is a positive development ahead of commercial launch of the FDA-authorized product, as it builds confidence with clinicians before choosing to switch to in-house testing.

We believe that over the next three years, the organ transplant rejection testing market is likely to shift from one that is primarily dominated by tests used toavoid biopsies in for-cause patientsto tests thatactively manage patients post-transplant.Importantly, we believe this will enable a new era of surveillance, prophylaxis and therapy monitoring: Clinicians will be trying to catch organ rejection as early as possible so that kidneys express less damageandstay in patients longer.

Monitoring the health of a transplanted organ is important, because everyone – from patient to clinician to donors at the time that they selflessly opt into organ donation – wants the donated organ to support another person’s second shot at life. For this reason, transplanted organ rejection is a major and heartbreaking tragedy.

Our assay is designed to help clinicians monitor the health of the patient’s transplanted organ. It does this by measuring donor-derived cell-free DNA (dd-cfDNA), which is fragments of DNA from the transplanted organ that circulate in the patient’s bloodstream. When the organ is healthy, these fragments are present at low, stable levels. And when the organ is under stress or being rejected, more organ cells are injured and release higher amounts of this DNA into circulation. By measuring this signal through a simple blood draw, dd-cfDNA testing provides a non-invasive readout of organ health. This type of testing is already available on the market via a test-send-out model from centralized labs. We are seeking to enable transplant centers to perform this type of testing in-house.

What we are finding is that our assay may offer unique benefits beyond simply enabling in-house testing with shorter turnaround times. We believe that the unique design of our assay is also poised to expand the clinical usefulness of dd-cfDNA testing, for reasons we discuss below.

Our assay can measure both the absolute quantities of the donated organ’s DNA fragments as well as their relative quantities. One historical limitation of dd-cfDNA testing has been that it works well in finding antibody-mediated rejection (AMR), but not so well with finding t-cell mediated rejection (TCMR). Recent work done with our research partners, built on the recent publication by Vaulet et al., referenced below, shows how well our assay’s CM-score performed (p=0.0158) at finding TCMR-related activity. One explanation may be,per the paper,“that infiltrating recipient immune cells undergo cell death within the graft during TCMR, contributing substantially to circulating total cfDNA levels and thereby diluting the relative dd-cfDNA fraction when expressed as a percentage. … [O]ur findings for the first time provide a plausible mechanistic explanation for why low-grade TCMR is difficult to detect when dd-cfDNA is expressed as a percentage alone.”

In layman’s terms, it looks like TCMR may be self-masking. By putting more recipient DNA into the blood, TCMR throws off the fractional measurement of dd-cfDNA, making the signal harder to see. Because our assay was designed toalsoquantify the absolute amount of dd-cfDNA, which is unaffected by the increase in recipient DNA, these data suggest that our assay may allow for a more accurate measure of the likelihood of transplanted organ rejection.

Later this year, we expect to see more publications coming out that show how combining the relative and absolute measure (CM-score) improves the positive predictive value of dd-cfDNA testing. Meaning, using our assay has the potential benefit of fewer false positives, and therefore helping clinicians to potentially avoid unnecessary biopsies. We expect this will become more important as the market for dd-cfDNA shifts fromfor-causetesting to ongoing monitoring, or screening.

We believe that screening organs will only increase in importance as new and more effective ways to treat organ rejection emerge. In recent quarters, better pharmaceutical solutions to organ rejection are starting to gain a foothold – including in the form of anti-CD38 drugs, which are immunotherapies that were developed to treat cancer. We are starting to see signs that 2026 could be the year that anti-CD38 drugs such as felzartamab and daratumumab start to enter routine clinical practice in treating transplanted organ rejection.

Multiple studies are on-going and results that show effective management of AMR are likely to build on the excitement that was generated with the publication of the phase 2 study of felzartamab in the New England Journal of Medicine (NEJM). As a reminder, our assay was used in monitoring the transplanted organ health in the ground-breakingNEJM study published in 2024, which led to the FDA’s Breakthrough Therapy Designation of felzartamab in October 2024.

Finally, and even more favorably, GraftAssure’s ability to pick up on low levels of signal – known as sensitivity – may also play a role in expanding the clinical utility of dd-cfDNA testing. We have demonstrated analytical sensitivity for dd-cfDNA quantification at low levels and the lowest relative change value (RCV), defined as the difference between the two values to signify meaningful change, both critical for recurrence monitoring. GraftAssure can quantify lower levels of dd-cfDNA and pick up meaningful longitudinal trends well before the moment of pathogenesis and graft deterioration.

In sum, we believe that our assay’s positive predictive value and analytical performance both position GraftAssure well to be the technology of choice in this emerging clinical environment.

References:

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iMDx’s flagship transplant testing technology quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). The company’s scientists in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA as a trusted biomarker of transplant rejection. iMDx is commercializing this technology using a market-disruptive business strategy. Under the GraftAssure™ brand, iMDx’s transplant diagnostics include the following:

Insight Molecular Diagnostics is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. Investors may visit https://investors.imdxinc.com/ for more information.

GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight Molecular Diagnostics Inc.

Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, demand for iMDx’s products and what the company is building, the expectation that decentralized testing will deliver new value in the roughly $2 billion-plus addressable market for kitted transplant rejection testing, the company’s competitive advantage and path to supplying the world’s most widely used dd-cfDNA assay, iMDx’s expectations for FDA review and authorization and its 2026 goals (including but not limited to commercial, regulatory and R&D goals), management’s thoughts on where transplant patient management is headed and why the company is well-positioned, emerging clinical utility of dd-cfDNA testing, the belief that democratizing access to transplanted organ rejection testing creates a rapidly growing, high-margin, recurring business model, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Insight Molecular Diagnostics’ third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Insight Molecular Diagnostics or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Insight Molecular Diagnostics, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Insight Molecular Diagnostics’ Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Insight Molecular Diagnostics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

In addition to financial results determined in accordance with U.S. generally accepted accounting principles (“GAAP”), this press release also includes non-GAAP financial measures (as defined under SEC Regulation G). We believe that disclosing the adjusted amounts is helpful in assessing our ongoing performance, providing insight into the Company’s core operating performance by excluding certain non-cash and other non-operating items that may obscure the underlying trends in the business. These non-GAAP financial measures, when viewed in a reconciliation to respective GAAP financial measures, provide an additional way of viewing the Company’s results of operations and factors and trends affecting the Company’s business. These non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the respective financial results presented in accordance with GAAP.

The following is a reconciliation of the non-GAAP financial measures to the most directly comparable GAAP measure:

(1) The 2024 reconciliation line-items have been presented to conform to the 2025 presentation. The newly titled total “Adjusted EBITDA loss, a non-GAAP financial measure” reported for 2024 is unchanged from the 2024 “Consolidated non-GAAP loss from operations, as adjusted” as previously reported.