The study shows consistent results for IMDX's digital PCR-based test kits using IMDX's flagship technology and commercially available DD-CFDNA test kits and NGS kits, as well as 96 implant patients. Major Opinion Leader Calls are planned
NASHVILLE, Tennessee, June 23, 2025 (Globe Newswire) – Insight Molecular Diagnostics, or IMDX (NASDAQ: IMDX) today announced positive results from a study evaluating flagship test kit technology with head-to-head comparisons with another commercially available test kit.
The findings showed comparable measurements of donor-derived cellular DNA (DD-CFDNA), a molecular biomarker used to assess the risk of transplant rejection between the two platforms studied.
This positive data supports IMDX's top priority of launching its first clinical molecular diagnostic test kit and capturing value in the estimated $1 billion transplant removal test market. Until 2025, IMDX is taking the key steps necessary to move from product development to commercialization.
“The initial comparison of this kind of this kind shows that digital PCR and NGS platforms bring comparable DD-CFDNA results to kidney transplant recipients. The tight correlation across pathological categories (Banff 2022) demonstrated in all biopsies confirms the clinical compatibility of both methods. “In addition, while both approaches are clinically aligned, digital PCR shows improved analytical sensitivity, suggesting the potential benefits of detecting DD-CFDNA at low doses.”
IMDX CEO Josh Riggs added: “As we prepare to launch commercially following regulatory approvals, which are expected next year, this direct data is extremely valuable. The findings give us confidence that our platform will work on par with the NGS-based options currently on the market.”
Research details
This study was conducted by German university hospital Heidelberg and represents the first direct comparison of two commercially available DD-CFDNA test kits based on single nucleotide polymorphisms (SNPs). One test uses Next Generation Sequence (NGS), while the other uses Digital Polymerase Chain Reaction (digital PCR) by IMDX, Grafassure (now branded as GrafassureiQ). (A single nucleotide polymorphism, or SNP, is a variation at a single position in a DNA fragment that can be used to distinguish donor and recipient DNA.)
Unlike a sequencing-based approach, digital PCR does not sequence DNA, but accurately quantifies specific DNA targets within a sample.
Grafatassureiq allows for absolute and relative quantification of DD-CFDNA using validated, patient-specific variants. This study evaluated 96 kidney transplant recipients who were undergoing biopsies during the biopsy period. The results showed comparable measurements between the two platforms, supporting their reliability and strengthened the role of DD-CFDNA testing in routine transplant care.
To avoid doubt, the researched Grafassureiq is a research-use-only assay for IMDX and is sold for research purposes. Importantly, and as previously communicated by IMDX, GraftassureiQ may not be used to support clinical treatment decisions. The company is also developing GraftasudedDX and intends to seek regulatory approval for clinical use.
ESOT in London: Data Presentation and Booth Exhibition Invitation
Extended data from this study will be featured in the upcoming European Organ Transplant Association (ESOT) Parliament Poster Abstract, which will be held in London from June 29th to July 2nd. This follows data published at the European Kidney Association in Vienna, Austria, from June 4th to June 7th, 2025.
The company will also be exhibited at ESOT during the meeting. Participants will be visiting the IMDX booth (D46) to learn more about GraftassureiQ and the various initiatives IMDX offers to support transplant centers engaged in cutting-edge R&D.
The company encourages research institutions to explore opportunities for collaboration, accelerate scientific discoveries in transplant medicine, and to stop by to promote ways in which Graftsalek improves the research goals of their respective centers.
Telephone Conferences between Key Opinion Leaders with National Chief Researchers
Separately, Insight Molecular Diagnostics (IMDX) will host an upcoming Key Opinion Leader (KOL) webinar featuring Dr. Anthony J. Langone of Vanderbilt University Medical Center, the National Chief Investigator (NPI) of IMDX's Continued Kidney Transplant Monitoring Trials.
Additional details, including registration information, will be provided as a few weeks leading up to the event and as part of the company's second quarter 2025 revenue release.
About Insight Molecular Diagnostics Inc.
Insight Molecular Diagnostics Inc. or IMDX, formerly Oncocyte Corp. (OCX), is a pioneering diagnostic technology company with a mission to democratize access to new molecular diagnostic tests 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, California to Nashville, Tennessee in June 2025. The company's new NASDAQ symbol came into effect on June 18th.
IMDX Ported Products and Product Candidates Under Development
The company's flagship implantation technology quantifies molecular biomarkers known as donor-derived cell-free DNA (DD-CFDNA). Over the past decade, scientists from the company in Germany and the US have played a key role in developing science that can help establish DD-CFDNA as a reliable biomarker for transplant rejection. IMDX is currently commercializing its technology using a disruptive market approach. Its port diagnosis based on the Graftassure™ brand includes:
GraftassureCore – The company's lab development test (LDT) is currently being refunded by CMS and is being conducted at the CLIA-certified Institute in Nashville. The company is in the process of rebranding its lab development test, Vitagraft Assay (also known as Vitagraft Kidney), named GraftassureCore. For the purposes of this press release, any reference to “Graftassurecore” shall be deemed to include previously sold tests as Vitagrafts.
graftassureiq – A research use (RUO) kit for non-clinical applications, so clearly labelled.
GraftasudeDX – An in vitro diagnostic (IVD) kit currently under development for use in clinical decision making.
Forward-looking statements
Statements that are not historical facts (including, but not limited to, statements containing words such as “will,” “believe,” “plan,” “expected,” “expected,” “estimate,” “May,” and similar formulas are forward-looking statements. These statements include, among other things, those relating to anticipated regulatory approval and commercial launches, and other statements regarding future expectations, beliefs, goals, plans, or prospects expressed by the controller. Forward-looking statements include risks, clinical trials, and the inherent risks, clinical trials and the like inherent in the development and/or commercialization of a diagnostic test or product. Forward-looking statements include risks and uncertainties, including the uncertainty of the outcome of regulatory approvals, the ability of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party third party third party third party supply blood sample analysis systems to maintain the capacity of IMDX's third party third party third party third party third party third Need to obtain a third party obligation, the need to obtain a third party reimbursement for the use of a patient's diagnostic IMDX or its subsidiaries, or the need to obtain a third party reimbursement to claim risks inherent in potential benefits such as potential benefits such as potential benefits that realize a potential barrier to applicable benefits. Also, the need to obtain a third party reimbursement to claim risks inherent in jurisdictions, accounting and quality control, estimated allocation of resources to develop and commercialize technology; is a potential failure in maintaining laboratory certification or certification. Actual results may differ materially from those expected in these forward-looking statements. Therefore, you should evaluate it along with many uncertainties affecting IMDX's business, particularly “risk factors” and other caution statements seen in IMDX's Securities and Exchange Commission (SEC), along with many uncertainties available from the SEC website. You should be careful not to overly rely on forward-looking statements. IMDX is not obligated to update such statements to reflect events or circumstances that occur, except as required by law.
Investor Contact Information:
Doug Farrell
Lifesci Advisors LLC
dfarrell@lifesciadvisors.com
