iMDx Reports Strong Head-to-Head Data in Kidney Transplant Rejection Testing
iMDx (NASDAQ:IMDX) announced positive results from a head-to-head study comparing its GraftAssureIQ digital PCR-based test kit with NGS-based technology for kidney transplant rejection testing. The study, conducted at University Hospital Heidelberg, evaluated 96 kidney transplant recipients and demonstrated equivalent measurements between the two platforms in detecting donor-derived cell-free DNA (dd-cfDNA).
The company's digital PCR technology showed improved analytical sensitivity in detecting dd-cfDNA in low quantities. This data supports iMDx's preparation for commercial launch following expected regulatory approval in 2026, targeting the estimated $1 billion transplant rejection testing market. Extended study data will be presented at the upcoming European Society of Organ Transplantation Congress in London.
iMDx (NASDAQ:IMDX) ha annunciato risultati positivi da uno studio comparativo diretto tra il suo kit di test digitale basato su PCR GraftAssureIQ e la tecnologia basata su NGS per il rilevamento del rigetto nei trapianti renali. Lo studio, condotto presso l'Ospedale Universitario di Heidelberg, ha valutato 96 riceventi di trapianto renale e ha dimostrato misurazioni equivalenti tra le due piattaforme nel rilevamento del DNA libero derivato dal donatore (dd-cfDNA).
La tecnologia digitale PCR dell'azienda ha mostrato una maggiore sensibilità analitica nel rilevare dd-cfDNA in quantità ridotte. Questi dati supportano la preparazione di iMDx per il lancio commerciale previsto dopo l'approvazione regolatoria attesa nel 2026, mirando all'estimato mercato da 1 miliardo di dollari per i test di rigetto del trapianto. I dati estesi dello studio saranno presentati al prossimo Congresso della European Society of Organ Transplantation a Londra.
iMDx (NASDAQ:IMDX) anunció resultados positivos de un estudio comparativo directo entre su kit de prueba digital basado en PCR GraftAssureIQ y la tecnología basada en NGS para la detección del rechazo en trasplantes renales. El estudio, realizado en el Hospital Universitario de Heidelberg, evaluó a 96 receptores de trasplante renal y demostró mediciones equivalentes entre ambas plataformas para detectar ADN libre derivado del donante (dd-cfDNA).
La tecnología digital PCR de la compañía mostró una mayor sensibilidad analítica para detectar dd-cfDNA en cantidades bajas. Estos datos respaldan la preparación de iMDx para el lanzamiento comercial tras la aprobación regulatoria esperada en 2026, apuntando al estimado mercado de pruebas de rechazo de trasplante de 1 mil millones de dólares. Los datos ampliados del estudio se presentarán en el próximo Congreso de la Sociedad Europea de Trasplante de Órganos en Londres.
iMDx (NASDAQ:IMDX)는 신장 이식 거부 반응 검사에 사용되는 자사의 GraftAssureIQ 디지털 PCR 기반 테스트 키트와 NGS 기반 기술을 직접 비교한 연구에서 긍정적인 결과를 발표했습니다. 하이델베르크 대학병원에서 수행된 이 연구는 96명의 신장 이식 수혜자를 평가했으며, 두 플랫폼 간에 기증자 유래 세포 유리 DNA(dd-cfDNA) 검출에서 동등한 측정 결과를 보였습니다.
회사의 디지털 PCR 기술은 적은 양의 dd-cfDNA 검출에서 향상된 분석 민감도를 나타냈습니다. 이 데이터는 2026년 예상되는 규제 승인 후 상업 출시를 준비 중인 iMDx를 뒷받침하며, 약 10억 달러 규모의 이식 거부 반응 검사 시장을 목표로 하고 있습니다. 확장된 연구 데이터는 곧 런던에서 열리는 유럽 장기 이식 학회에서 발표될 예정입니다.
iMDx (NASDAQ:IMDX) a annoncé des résultats positifs issus d'une étude comparative directe entre son kit de test numérique basé sur la PCR GraftAssureIQ et la technologie basée sur le NGS pour le dépistage du rejet de greffe rénale. L'étude, menée à l'Hôpital Universitaire de Heidelberg, a évalué 96 receveurs de greffe rénale et a démontré des mesures équivalentes entre les deux plateformes dans la détection de l'ADN libre circulant dérivé du donneur (dd-cfDNA).
La technologie PCR numérique de la société a montré une sensibilité analytique améliorée pour détecter le dd-cfDNA en faibles quantités. Ces données soutiennent la préparation d'iMDx pour un lancement commercial après l'approbation réglementaire prévue en 2026, visant le marché estimé à 1 milliard de dollars pour les tests de rejet de greffe. Les données étendues de l'étude seront présentées lors du prochain Congrès de la Société Européenne de Transplantation d'Organes à Londres.
iMDx (NASDAQ:IMDX) gab positive Ergebnisse einer direkten Vergleichsstudie zwischen dem digitalen PCR-basierten Testkit GraftAssureIQ und der NGS-basierten Technologie zur Erkennung von Nierentransplantatabstoßungen bekannt. Die Studie, durchgeführt am Universitätsklinikum Heidelberg, bewertete 96 Nierentransplantatempfänger und zeigte äquivalente Messergebnisse beider Plattformen bei der Detektion von donorabgeleiteter zellfreier DNA (dd-cfDNA).
Die digitale PCR-Technologie des Unternehmens zeigte eine verbesserte analytische Sensitivität bei der Erkennung von dd-cfDNA in niedrigen Mengen. Diese Daten unterstützen die Vorbereitung von iMDx auf den kommerziellen Start nach der erwarteten behördlichen Zulassung im Jahr 2026 und zielen auf den geschätzten 1-Milliarden-Dollar-Markt für Transplantatabstoßungstests ab. Erweiterte Studiendaten werden auf dem bevorstehenden Kongress der European Society of Organ Transplantation in London vorgestellt.
- Study demonstrates equivalent performance between iMDx's digital PCR test and current NGS-based options
- Digital PCR technology showed improved analytical sensitivity for low quantity detection
- Targeting estimated $1 billion transplant rejection testing market
- Regulatory approval expected next year
- Strong validation from University Hospital Heidelberg study with 96 patients
- GraftAssureIQ currently limited to research use only, cannot support clinical treatment decisions
- Commercial launch pending future regulatory authorization
Insights
iMDx's transplant rejection test shows equivalence to existing technologies, positioning it well for the $1B market opportunity.
iMDx's head-to-head study results represent a significant clinical validation milestone for the company's kidney transplant rejection testing technology. The study demonstrated that their digital PCR-based GraftAssureIQ test kit produced equivalent measurements of donor-derived cell-free DNA (dd-cfDNA) compared to commercially available next-generation sequencing (NGS) methods across 96 transplant patients.
What makes this particularly compelling is that digital PCR technology potentially offers improved analytical sensitivity for detecting low quantities of dd-cfDNA, while maintaining clinical equivalence with current market options. This technical advantage could become a key differentiator in the estimated
The company's strategic approach follows a well-established pathway to commercialization: demonstrating technical equivalence or superiority to existing methods, building clinical evidence through multiple institutional studies, engaging key opinion leaders, and presenting at major scientific conferences. The upcoming extended data presentation at ESOT and involvement of Dr. Anthony Langone from Vanderbilt as national principal investigator further strengthens their scientific credibility.
From a regulatory perspective, it's important to note the distinction between their research-use-only GraftAssureIQ (studied here) and the in-development GraftAssureDx intended for clinical use pending regulatory authorization. This dual-track approach allows iMDx to generate revenue and clinical evidence simultaneously while navigating the regulatory process.
The company's focus on transplant rejection testing addresses a critical unmet need in transplantation medicine, where early detection of rejection can significantly improve outcomes. If iMDx can secure regulatory approval as expected next year, they'll be well-positioned to capture market share in this specialized but lucrative diagnostic space.
- Study indicates iMDx flagship technology’s equivalence with commercially available dd-cfDNA test kits
- Head-to-head comparison of iMDx’s digital PCR-based test kits with NGS kits shows consistent results in 96 transplant patients
- Data was presented at the European Renal Association (ERA) 2025
- Extended data to be presented at the European Society of Organ Transplantation (ESOT) Congress in London, June 29 – July 2
- Upcoming National Principal Investigator and Key Opinion Leader call planned
NASHVILLE, Tenn., June 23, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics, or iMDx, (Nasdaq: IMDX), today announced positive results from a study evaluating its flagship test kit technology in a head-to-head comparison with another commercially available test kit.
The findings indicated equivalent measurements of donor-derived cell-free 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
“This first of its kind, head-to-head comparison demonstrates that digital PCR and NGS platforms deliver equivalent dd-cfDNA results in kidney transplant recipients. We believe the tight correlation across all biopsy-proven pathology categories (BANFF 2022) confirms the clinical interchangeability of both methods,” said iMDx Chief Science Officer Dr. Ekkehard Schuetz. “Furthermore, while both approaches aligned clinically, digital PCR showed improved analytical sensitivity, suggesting potential advantages in detecting dd-cfDNA in low quantities.”
Added iMDx CEO Josh Riggs, “Head-to-head data like this is highly valuable as we prepare for commercial launch following expected regulatory approval next year. The study results give us confidence that our platform performs on par with NGS-based options currently on the market.”
More Details About the Study
The study was conducted by the University Hospital Heidelberg in Germany 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 sequencing (NGS), while the other – iMDx’s GraftAssure, now branded as GraftAssureIQ – uses digital polymerase chain reaction (digital PCR). (A single nucleotide polymorphism, or SNP, is a variation at a single position in a DNA fragment that can be used to distinguish between donor and recipient DNA.)
Unlike sequencing-based approaches, digital PCR does not sequence DNA but instead precisely quantifies specific DNA targets in a sample.
GraftAssureIQ enables both absolute and relative quantification of dd-cfDNA using validated patient-specific variants. The study evaluated 96 kidney transplant recipients undergoing for-cause biopsies. Results showed equivalent measurements between the two platforms, supporting their reliability and reinforcing the role of dd-cfDNA testing in routine transplant care.
For the avoidance of doubt, GraftAssureIQ, which was studied, is iMDx’s research-use-only kitted assay and is available for sale for research purposes. Importantly, and as previously communicated by iMDx, GraftAssureIQ may not be used to support clinical treatment decisions. The company is concurrently developing GraftAssureDx and intends to seek regulatory authorization for its clinical use.
ESOT in London: Data Presentation and Booth Exhibition Invitation
Extended data from the study will be presented in a poster abstract at the upcoming European Society of Organ Transplantation (ESOT) Congress, being held in London from June 29th through July 2nd. This follows the data that was presented at the European Renal Association 2025 in Vienna, Austria, from June 4th to June 7th 2025.
The company will also be exhibiting at ESOT throughout the duration of the conference. Attendees are invited to visit the iMDx booth (D46) to learn more about GraftAssureIQ, and the different initiatives that iMDx is offering to support transplant centers engaged in cutting-edge R&D.
The company encourages research institutions to stop by to explore collaboration opportunities, accelerating scientific discovery in transplant medicine, and how GraftAssureIQ could help advance their respective center’s research goals.
Key Opinion Leader Conference Call with National Principal Investigator
Separately, Insight Molecular Diagnostics (iMDx) plans to host an upcoming Key Opinion Leader (KOL) webinar featuring Dr. Anthony J. Langone of Vanderbilt University Medical Center, who also serves as the national principal investigator (NPI) for iMDx’s ongoing kidney transplant monitoring trial.
Additional details, including registration information, will be provided in the weeks leading up to the event and as part of the company’s Q2 2025 earnings announcement.
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.
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.
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
FAQ
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