IMDX Reports Q2 2025 Results and Momentum Toward GraftAssureDx Launch

NASHVILLE, Tenn., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., or iMDx, (Nasdaq: IMDX), today published the following letter to shareholders in conjunction with its second quarter results:

Fellow shareholders,

We are closer than we have ever been to delivering a regulated kitted transplant monitoring assay to the market – and we are pleased to report a series of recent and timely accomplishments that we believe amount to material progress. These recent developments, which we highlight below, as well as ongoing strategic discussions, have strengthened our confidence regarding our ability to capture share in the $1 billion total addressable transplant rejection testing market.

To recap what we mean by aregulated kitted assay:We are designing a complex molecular lab test so that it can fit into a box, or a kit, to enable localized diagnostic testing. In January 2023, when we first decided to commercialize our transplant rejection-related intellectual property (IP) by designing a kitted test, we essentially planted a flag that said that we would put our assay through the regulatory approval processes of the FDA and its EU equivalent. This decision was significant because in the U.S., we estimate that most complex molecular diagnostics tests have been runwithoutFDA authorization, which has limited their market penetration.

Moreover, these non-FDA-authorized North American lab tests, which are performed at centralized locations, are not easily accessible to hospitals in the rest of the world. Therefore, obtaining regulatory authorization is a key step toward achieving our mission to democratize access to these important tests. With FDA and EU-equivalent authorization, we anticipate selling test kits to hospital labs, thereby empowering hospitals to run the tests themselves to expediently deliver actionable results.

It is our belief that if we do the hard work of designing a lab test in a kitted form and achieve regulatory authorization, then we will not only democratize access to these tests – thereby bringing care closer to the patient and helping hospitals to operate more sustainably – but also create a rapidly growing, high-margin, recurring revenue business model.

We continue to carefully manage our FDA data submission project and remain on track to submit our kitted test, GraftAssureDx, for FDA review by the end of this year, which is a reiteration of the timeline that we communicated in our March and May shareholder letters. This means that we could begin marketing GraftAssureDx, the newest in our GraftAssure-branded family of products, upon FDA authorization as soon as mid-2026.

Since our May 12thshareholder letter, we have made consistent progress across three fronts:

Also in the second quarter, we renamed the company and moved our headquarters to Nashville:On June 17th, werenamed our companyfrom Oncocyte to Insight Molecular Diagnostics. In hisinaugural annual letterto shareholders, CEO Josh Riggs wrote,“While molecular diagnostic testing has advanced significantly in recent years, many times access remains limited -- constrained by geography, cost, and the need for centralized labs. Our mission is to democratize access to molecular diagnostic testing to improve patient outcomes. We aim to lead in molecular diagnostics by doing what sets technology companies apart: developing proprietary algorithms that drive scalable value.”We also moved our headquarters from Irvine, Calif., to Nashville, Tenn., which is the home of our accredited lab.

We are highly focused on concluding our clinical trial and submitting GraftAssureDx to the FDA to seek marketing authorization. We are aiming to submit to the FDA by the end of the year, representing no change from our prior communication, and we continue to tightly manage and monitor several interlocking work streams to support this timeline. It's important to note that we don’t expect there to be significant delays between the close of our clinical trial and our FDA data submission, because our FDA data submission will be templated, which means that as the clinical trial results come in, we can drop the data into our template, perform quality checks and execute the submission.

Beyond that, we are not stopping at kidney. From 2026 to 2028, we see at least six potential areas for clinical and regulatory expansion of our dd-cfDNA kitted assays alone. These include monitoring therapeutic response to drugs that reduce immune-system-driven organ rejection, recurrence monitoring for kidney transplant rejection, indications using urine, and expansions into heart, lung, and liver transplant rejection testing. Each of these programs builds on the same cfDNA platform we’re already using and provides a path to expand how the test can be used to help more transplant patients.

Finally, we wanted to raise the curtain slightly on what we believe is a developing powerful and differentiated scientific story for our kitted assay, particularly with the World Transplant Congress data that we presented and future clinical data that we hope to publish. While we have communicated with shareholders all along that our kitted strategy is most likely to be successful thanks to shorter testing turn-around times and revenue generation for transplant centers, we also are starting to build a scientific case for why digital PCR, which is natively quantitative, can enable use cases for dd-cfDNA testing beyond what’s currently on the market.

So, with the necessary caveated prudence of not over-selling this point, we believe that the data points regarding both absolute quantification as well as relative quantification are exciting. We believe our kitted assay will enable testing over the life of the kidney transplant patient, from early detection of antibody-mediated rejection (AMR-based organ rejection), therapeutic efficacy for treating AMR (that is, monitoring whether the drugs to treat rejection are working), to an MRD-like recurrence monitoring model for organ rejection. (MRD, or minimum residual disease, testing is a term that is already well-known in the oncology sector and we believe our assay may enable a similar model in transplant.)

We look forward to continuing to update you on our scientific and commercial progress.

- The iMDx Management Team

Those interested may access the live Zoom call by registering here:Insight Molecular Diagnostics Q2 2025 Earnings Webinar.

Once registered, a confirmation email will be sent with instructions.

A replay of the Zoom call will be available on the company’s website shortly after the call.

Insight Molecular Diagnostics (iMDx) will host a virtual key opinion leader (KOL) event on Friday, August 15, 2025, at 4:00 PM ET featuring Anthony Langone, MD (Associate Professor of Medicine, Division of Nephrology and Hypertension, Vanderbilt University).

To register,click here.

About Insight Molecular Diagnostics, Inc.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 visithttps://investors.Insight Molecular Diagnostics.com/for more information.

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

Forward-Looking StatementsAny 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, the Company’s continued development of a regulated kitted assay, regulatory progress, ongoing clinical trial, upcoming webinar(s), the expected impact of MolDx’s final LCD, the Company’s Land and Expand strategy, sales forecasts, product pipeline, 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.

Note: In addition to financial results determined in accordance with U.S. generally accepted accounting principles (“GAAP”), this press release also includes a non-GAAP financial measure (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 / or intangible items that may obscure the underlying trends in the business. These non-GAAP financial measures, when viewed in a reconciliation to respective GAAP 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 measure to the most directly comparable GAAP measure:

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