NASHVILLE, Tenn., Aug. 11, 2026 (GLOBE NEWSWIRE) — Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today announced that it will host a virtual key opinion leader (KOL) event on Monday, August 17, 2026 at 11AM ET featuring Max Jacob Liebo, MD (Loyola University Medical Center), who will join Nick Ioannou, MD, MHA (iMDx VP Medical Affairs) and Josh Riggs (iMDx CEO), to discuss the Company’s GraftAssure platform, which leverages digital PCR technology to deliver reliable dd-cfDNA results for transplanted organ health monitoring. To register, click here.

The event will provide an overview of GraftAssure, currently under review by the FDA to be commercialized in kitted form for labs to test patients for kidney transplant rejection. Dr. Liebo will discuss how a kitted GraftAssure test (GraftAssureDx) can be used for in-house heart transplant rejection monitoring, as well as implications for the industry and patients.

A live question and answer session will follow.

About Max Jacob Liebo, MD
Max Jacob Liebo, MD specializes in cardiovascular disease and internal medicine, focusing on comprehensive heart and vascular care. Dr. Liebo treats patients with a wide range of cardiovascular conditions while also providing general internal medicine services. Dr. Liebo practices at Ronald McDonald Children’s Hospital of Loyola University Medical Center, an affiliation that demonstrates his commitment to specialized patient care. Dr. Liebo completed extensive training including fellowships at Cleveland Clinic Hospital in 2013 and Scripps Green Hospital in 2012. He also completed his internship at Scripps Green Hospital in 2007 and residency there in 2009.

About Nick Ioannou, MD, MHA
Nick Ioannou, MD, MHA is the Vice President, Medical Affairs at iMDx, and a physician-scientist with more than three decades of highly relevant experience spanning clinical practice, diagnostics, regulatory affairs, medical education, and medical affairs. His background includes over fifteen years of field-based collaboration with key opinion leaders across multiple therapeutic areas, particularly in organ transplantation (nephrology, cardiology, pulmonology) and oncology. Dr. Ioannou has served in several senior medical affairs roles at Guardant Health, Natera, LA ORT Institute, L-Nutra, CSL Behring, Fresenius, and Baxter. Dr. Ioannou’s experience as a medical director and partner in private clinics for nearly 10 years has given him a keen ability to connect with patients and their families, as well as with physicians, nurses, and other healthcare partners, thus building strong and long-lasting professional relationships.

About Josh Riggs
Josh Riggs joined iMDx Corporation in August 2020 and was appointed Interim Chief Executive Officer in December 2022, after serving as Senior Director Business Development and General Manager, Transplant. Josh is an experienced business leader and was previously the founder and principal of Intelliger Consulting, an organization devoted to consumer driven healthcare, and a principal at Bethesda Group, LLC, a boutique consulting group focused on helping small and mid-stage diagnostic companies and investment groups move emerging diagnostic content and platforms to market.

About iMDx’s GraftAssure technology

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:

  • Bringing testing closer to the patient: The first is a shift in the location of where donor-derived cell-free DNA (dd-cfDNA) testing is performed – migrating out of a send-out service model and into hospital-based laboratories that can deliver results locally. iMDx seeks to demonstrate that in-house testing is better for patients and physicians. (As a reminder, dd-cfDNA is an established biomarker for assessing the health of a transplanted organ through a simple blood draw.)
  • Expanding the clinical role of dd-cfDNA: The second shift is the growing potential for dd-cfDNA testing, powered by digital PCR technology, to support earlier detection of allograft injury, longitudinal monitoring of transplant health, and assessment of response to emerging anti-rejection therapies.
  • Advancing from rule-out testing to comprehensive decision support: The third shift is the expansion of dd-cfDNA testing from mainly being used to rule out patients’ need for confirmatory biopsy testing, to also being used proactively to predict whether a patient may be progressing toward organ rejection. This important shift is enabled by GraftAssure’s ability to measure both dd-cfDNA percentage and absolute, true concentrations as copies per milliliter of plasma.

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:

  • GraftAssureCore – The company’s laboratory-developed test (LDT), currently reimbursed by CMS and performed at iMDx’s CLIA-certified laboratory in Franklin, Tennessee.
  • GraftAssureIQ – A research-use-only (RUO) kit intended and labeled for non-clinical applications.
  • GraftAssureDx – The in vitro diagnostic (IVD) kit currently under FDA review for use in clinical decision-making.

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™, VitaGraft™, 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, and the market expansion opportunity for, its GraftAssure technology, expected FDA marketing authorization to sell GraftAssureDx, anticipated paradigm shifts in transplanted organ health monitoring, 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


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Insight Molecular Diagnostics Inc.