IMDX Reports Second Quarter 2026 Results and Timely Progress on FDA Review of GraftAssureDx
NASHVILLE, Tenn., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., iMDx, (Nasdaq: IMDX), today published the following letter to shareholders in conjunction with its first quarter results:
Fellow shareholders,
We continue to be encouraged by progress toward our most important priority, which is to attain regulatory authorization of GraftAssureDx.
In late July, the FDA completed the current phase of its substantive review of GraftAssureDx in a timely manner. The agency requested additional information from us, which is typical in a regulatory authorization process such as this. We view ourselves as being in the later stages of the review process, and after a thorough dialogue with the agency, we are encouraged to be working with a clear, well-defined set of remaining items. This welcome milestone comes after three years of rigorous kitted product development.
We also have been pleased regarding the agency’s swift engagement and its ability to deliver timely feedback throughout. We have had productive dialogue with the agency since submitting GraftAssureDx for regulatory review in late March, and we expect that to continue. We would characterize our dialogue with the FDA as routine and within the realm of our expectations.
Our submission was, to our knowledge, the first-ever kitted dd-cfDNA assay to be submitted for FDA authorization.
As a reminder, we are not building this product alone. Our GraftAssure assay runs on a digital PCR instrument made by Bio-Rad Laboratories (NYSE:BIO), which has invested in our company. Bio-Rad commented:
"Our collaboration with iMDx on GraftAssureDx reflects the kind of innovative thinking we look for in a partner. Droplet Digital™ PCR is well suited to the demands of transplant monitoring, where precise and reproducible measurement matters, and GraftAssureDx brings that capability into the clinical laboratory setting. We are proud to partner with iMDx on this program and remain confident in the path forward and positive impact to patient lives." –Jonathan Seaton, SVP Corporate Business Development, Bio-Rad Laboratories
We also have expanded dialogue with several additional players in the diagnostics industry. We now believe that most major U.S. reference labs are interested in adopting in-house dd-cfDNA testing, with their interest bolstered by reimbursement clarity from Medicare and the release of favorable head-to-head data regarding our assay, both of which are described in more detail below.
High-volume labs that are performing other routine transplant tests are considering the addition of a reimbursed dd-cfDNA test. We believe they may see our test as a natural product line extension for their other transplant test offerings, and as a great way to serve their existing transplant center and nephrology clinic customers nationwide. We believe that these labs value the ability to deliver all the testing needed for a patient in one patient visit for blood draws, and even potentially via one report for clinicians.
Contextual overview for investors:
iMDx aims to deliver proven, more affordable, faster tests that can be run in-house at local transplant center laboratories. We have designed the GraftAssureDx molecular test to be sold as a test kit so that transplant center laboratories can run tests locally. By running tests locally, laboratories can deliver critical test results to the physicians of transplant patients much more quickly than can be done with the currently available send-out tests. Our company is now seeking FDA marketing authorization to sell these kits in the U.S. If GraftAssure technology becomes available commercially as a test kit, it may be an industry-transforming event for transplanted organ rejection monitoring.
Over time, iMDx sees three potential paradigm shifts in transplanted organ health monitoring:
Other highlights since our May 2026 update:
Reimbursement and market access
Clinical evidence and peer-reviewed publications
Commercial and scientific community engagement
Upcoming KOL call on August 17 th to highlight heart transplant testing:
As we continue to plan for commercializing a kitted version of GraftAssure for kidney transplant testing, the next organ of focus for GraftAssure’s application is heart transplant testing. To that end, we will be hosting a virtual key opinion leader (KOL) event to discuss in-house heart transplanted organ rejection testing on Monday, August 17, 2026, at 10:00 a.m. ET. The event will feature Dr. Max Jacob Liebo, M.D., Associate Professor and Program Director, Advanced Heart Failure and Transplant Cardiology Fellowship at Loyola University Medical Center.
The call will also feature brief remarks from CEO Josh Riggs and iMDx Vice President of Medical Affairs Dr. Nick Ioannou, whose extensive experience includes previously serving as a medical science liaison for organ health and genetics at Natera.
We will be issuing a separate press release with further information.
Thank you for your interest in iMDx and we look forward to updating you as we transition into commercialization.
Sincerely,
iMDx Management
Second Quarter 2026 financial overview
Webcast and Conference Call Information
Live Zoom Call and Webcast on August 10, 2026, at 2:00 PM PT / 5:00 PM ET.
Those interested may access the live Zoom call by registering here: iMDx Q2 2026 Earnings Webinar
A replay of the Zoom call will be available on the Company's website shortly after the call.
iMDx Transplant Products and Product Candidates in Development
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:
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 visit https://investors.imdxinc.com/ for more information.
GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Insight Molecular Diagnostics Inc.
Forward-Looking Statements
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, the company’s efforts to commercialize its GraftAssure technology, discussions with the FDA and expected FDA marketing authorization to sell GraftAssureDx, the belief that most major U.S. reference labs are interested in adopting in-house dd-cfDNA testing, interest from industry participants and investors, the company’s plans to deliver proven, more affordable and faster tests that can be run in-house at local transplant center laboratories, anticipated paradigm shifts in transplanted organ health monitoring, the belief that clinicians tend to increasingly use dd-cfDNA testing to guide ongoing anti-rejection drug therapy, potential use cases for GraftAssure beyond rejection detection and biopsy rule-out testing, the company’s upcoming KOL call to highlight heart transplant testing, transplant and other product candidates in development, 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.
FDA
CAUTION: This press release concerns certain products that are under clinical investigation, and which have not yet been cleared or authorized for marketing by the U.S. Food and Drug Administration. These products are currently limited by federal law to investigational use, and no representation is made as to the safety or effectiveness of these products for the purposes for which they are being investigated.
Investor Contact:
Douglas Farrell
LifeSci Advisors LLC
imdx@lifesciadvisors.com
Financial Tables Follow
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: