IMDx Chief Science Officer Ekkehard Schuetz Publishes 200th Research Paper

Key member of management ranks at top 2% of researchers in the field of laboratory diagnostics and top 2.5% of all researchers worldwide, based on H-index of 58
Recent studies advanced science of molecular diagnostic testing for transplanted organ rejection, published in Clinical Chemistry, Transplant International, American Journal of Transplantation and Nephrology Dialysis Transplantation, among others

NASHVILLE, Tenn., June 29, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today announced that its Chief Science Officer, Prof. Dr. Ekkehard Schuetz. M.D., Ph.D., has published his 200th scientific article.

Dr. Schuetz and Dr. Julia Beck are credited as co-inventors of the dd-cfDNA testing technology that underpins iMDx’s entire GraftAssure family of assays. This technology was acquired by iMDx (formerly known as Oncocyte Corporation) in 2021 through the acquisition of Chronix Biomedical, Inc., of which Dr. Schuetz was CEO. Dr. Schuetz has been deeply rooted in the academic and scientific communities for 35 years.

With an H-index of 58, a metric that measures both the productivity and the citation impact of a researcher's publications, Dr. Schuetz is ranked in the top 2.5% of all listed 2.6 million researchers worldwide (according to the AD Scientific Index) and in the top 2% of researchers in the field of laboratory diagnostics, which encompasses the fields of medical biochemistry, medical biology, chemical pathology, and clinical chemistry. His work has been cited more than 11,000 times according to Google Scholar.

“It’s been an absolute pleasure watching Ekke work. His scientific integrity and curiosity shine throughout his publications. I join everyone at iMDx in congratulating Dr. Schuetz on this monumental achievement,” iMDx CEO Josh Riggs said. “Dr. Schuetz is a well-known scientific leader and key member of the management team at iMDx. He also is one of the original inventors of the underlying science in our flagship technology that is in GraftAssure. His presence as Chief Science Officer is meaningfully validating for the company — the scientist who built our core technology is still running it, and we benefit from this scientific continuity. The GraftAssure technology and the data support behind it are all credited to Dr. Schuetz’s life's work.”

Dr. Schuetz commented, “For over three decades I have been actively publishing in the field of laboratory medicine and molecular diagnostics; and during the past 15 years, generating the clinical evidence base rationalizing the preferred use of dd-cfDNA technology. Studies we conducted at iMDx and before with my academic partners, for example, helped to establish the correlation between microvascular and vascular inflammation and elevated dd-cfDNA in blood plasma.”

Dr. Schuetz co-authored the first randomized interventional study to validate any dd-cfDNA technology as a rule-in test for biopsy in a high-risk population, published in Nephrology Dialysis Transplantation.

Dr. Schuetz has also co-led key clinical studies for iMDx at University Hospital Heidelberg, such as the head-to-head comparison study that was published in Clinical Chemistry — the first direct comparison of two commercially available dd-cfDNA test kits based on single nucleotide polymorphisms, or SNPs — which confirmed that a digital PCR approach showed improved analytical sensitivity over NGS-based approaches.

His recent accomplishment also includes co-authoring groundbreaking studies on improving the clinical usability of dd-cfDNA by combining percentage and absolute concentrations (known as CM-Score) of the biomarker, conducted with investigators from Heidelberg University Hospital and Charité – Universitätsmedizin Berlin:

Under Dr. Schuetz’s leadership, iMDx’s de novo FDA submission for marketing authorization of its GraftAssureDx kit earlier this year represents a major milestone toward iMDx’s strategic goal to become the leading provider of dd-cfDNA testing technology, and decentralizing access to molecular diagnostic transplant rejection testing.

About iMDx’s GraftAssure technology

iMDx is at a pivotal stage in commercializing its GraftAssure technology, which iMDx expects to be an industry-transforming transplanted organ rejection monitoring test. The company aims to deliver proven, more affordable, faster tests that can be run in-house at local transplant center laboratories. iMDx has designed a molecular test that it can sell as a test kit to help enable transplant center laboratories to run tests locally and deliver critical test results far more quickly than the current send-out tests. The company is now seeking FDA marketing authorization to sell these kits to transplant centers in the U.S.

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 where donor-derived cell-free DNA (dd-cfDNA) testing is performed – migrating out of centralized reference laboratories and into hospital-based laboratories capable of delivering results locally. The company 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 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 to comprehensive decision support: The third is a transition from the current rule-out-biopsy testing paradigm toward a more comprehensive rule-out and rule-in approach, enabled by GraftAssure’s ability to measure both dd-cfDNA percentage and absolute, or 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™, 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, 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
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Investor Contact:
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LifeSci Advisors LLC
imdx@lifesciadvisors.com

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