iMDx to Host Virtual KOL Event to Discuss its In-House dd-cfDNA Testing for Kidney Transplant Patients on August 15, 2025

NASHVILLE, Tenn., July 28, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics, or iMDx, (Nasdaq: IMDX), today announced that it 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.

Dr. Langone, who serves as the national principal investigator (NPI) for iMDx’s ongoing kidney transplant monitoring trial, will discuss the expanding role of donor-derived cell-free DNA (dd-cfDNA) in transplant care, patient management, and the benefits of enabling in-house testing.

In addition, the Company's management team will provide an overview of their kitted strategy, and the uniqueness of their GraftAssure™-branded in-house testing option. The GraftAssure™ family of assays, already available in lab-developed test form and as research-use-only kits, leverages advanced digital PCR (dPCR) technology to deliver highly quantitative, reliable dd-cfDNA results for transplant monitoring. The Company is developing a diagnostics test kit for clinical use, to enable hospitals to run their own tests, in-house.

A live question and answer session will follow the formal presentations. Those who are registered but unable to attend the virtual event live may send questions in advance of the event to questions@lifesciadvisors.com. Please send your questions at least 12 hours in advance of the event.

About Anthony Langone, MD

Anthony Langone, MD is an Associate Professor of Medicine in the Division of Nephrology and Hypertension within the Department of Medicine at Vanderbilt University Medical Center. He received his undergraduate degree from Cornell University where he graduated with honors. He completed his medical degree at the State University of New York at Buffalo School of Medicine and completed his residency at Baylor College of Medicine where he graduated AOA and with the McIntosh award, top resident honors. He completed general and renal transplantation fellowships at Vanderbilt, and was elected chief fellow in 2001. Dr. Langone’s clinical focus is on kidney and pancreas transplantation, amyloidosis and multiple myeloma. His research interests include ameliorating drug side effects and new drug and biomarker discovery. His professional activities include being an active member of the DCE Committee, the Nephrology Fellowship Clinical Competency Committee, a renal representative and founding member of the Vanderbilt Amyloidosis Multidisciplinary Program (VAMP), and the Medical Director of Medical Specialties Clinic. Dr. Langone is a Fellow of the American Society of Transplantation (FAST) and a member of the American Society of Nephrology (ASN). He is an active participant in multiple American Society of Transplantation Community of Practices (COPs).

About iMDx Transplant Products and Product Candidates in Development

The company’s flagship transplant 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, and iMDx is now commercializing that technology using a market disruptive approach. Its transplant diagnostics under the GraftAssure™ brand include the following:

GraftAssureCore – The company’s lab-developed test (LDT), currently reimbursed by CMS and performed at its CLIA-certified laboratory in Nashville. The company is in the process of rebranding its VitaGraft assay (also known as VitaGraft Kidney), which is a lab developed test, under the name GraftAssureCore. For purposes of this press release, references to “GraftAssureCore” shall be deemed to include the test previously marketed as VitaGraft.

GraftAssureIQ – A research-use-only (RUO) kit intended for non-clinical applications and clearly labeled as such.

GraftAssureDx – The in vitro diagnostic (IVD) kit currently in development for use in clinical decision-making, which the company intends to submit for FDA authorization.

About Insight Molecular Diagnostics Inc.

Insight Molecular Diagnostics Inc., or iMDx, formerly Oncocyte Corp. (OCX), is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes.

iMDx™, GraftAssureCore™, GraftAssureIQ™, GraftAssureDx™, and VitaGraft™ are trademarks of Insight Molecular Diagnostics Inc.

Insight Molecular Diagnostics (Nasdaq: IMDX) moved its headquarters from Irvine, Calif., to Nashville, Tenn., in June 2025. The company’s new NASDAQ symbol became effective June 18. Investors may visit https://investors.imdxinc.com/ for more information.

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, expected regulatory approval(s) and commercial launch, 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 iMDx’s 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 iMDx 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 iMDx, particularly those mentioned in the “Risk Factors” and other cautionary statements found in iMDx’s 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. iMDx 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.

Investor Contact:

Doug Farrell
LifeSci Advisors LLC
dfarrell@lifesciadvisors.com

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