INDUSTRY WORKSHOP: Donor-derived cell-free DNA for personalized immunosuppression in transplantation
Tracks
Track 1
| Wednesday, September 24, 2025 |
| 12:30 PM - 1:25 PM |
| Grand Copthorne Waterfront Hotel - Grand Ballroom I |
| Sponsored By: |
Overview
Delivered by Oncocyte
Details
Donor-derived cell-free DNA (dd-cfDNA) is an effective diagnostic tool for serial surveillance of allograft health. Absolute quantification of dd-cfDNA is superior to fractional determination as it is not affected by changes of total cfDNA. Recently a new dd-cfDNA test kit for quick in-house determinations (GraftAssureTM) has been developed based on ddPCR with preselected SNPs, which enables measurements of fractional abundance (%) and absolute concentration (cp/ml). Significantly elevated absolute dd-cfDNA levels (cp/ml) were found in patients with acute or chronic antibody mediated rejection (ABMR), DSA negative patients with microvascular inflammation or BK-virus nephropathy. Low-grade T-cell-mediated rejection (TCMR) (IA) without vascular injury was not well detected in plasma in contrast to high-grade TCMR. The diagnostic performance of plasma dd-cfDNA for rejection detection is in general very good for kidney, heart, lung and liver transplant recipients (range of mean values: AUC-ROC 0.79 - 0.95, sensitivity 66 - 90 %, specificity 76 - 88 %, PPV 33 - 63 %, NPV 89 - 100 %). ABMR remains a major therapeutic challenge and causes about 20 - 30 % of allograft failures. Dd-cfDNA is useful for early ABMR detection, in particular in DSA+ patients. New treatment options using CD38-targeting monoclonal antibodies (CD38 mAB) are currently evaluated and dd-cfDNA has been used successfully as a companion biomarker in patients with chronic ABMR. In a recent randomized clinical trial longitudinal dd-cfDNA monitoring was performed for ABMR detection in kidney transplant recipients. The time from study inclusion to ABMR diagnosis was on average 2.8 months in the intervention group with dd-cfDNA guided biopsy and 14.5 months in the control group with clinician guided biopsy. In contrast to ABMR there was no significant elevation of dd-cfDNA in patients with IgA nephropathy (IgAN). Based on currently available evidence Medicare provides coverage for dd-cfDNA routine testing in the US. Dd-cfDNA facilitates personalized immunosuppression and cost-effective transplant recipient surveillance with the potential to reduce premature graft loss.
Speaker
Prof Michael Oellerich
Distinguished Research Professor of Clinical Chemistry
University Medical Centre Goettingen
Applications of dd-cfDNA and opportunities for decentralized testing
Abstract
Donor-derived cell-free DNA (dd-cfDNA) is an effective diagnostic tool for non-invasive surveillance of allograft health. Absolute quantification of dd-cfDNA offers advantages to fractional determination as it is not affected by changes of total cfDNA. Recently a new dd-cfDNA test kit for quick decentralized in-house determinations (GraftAssureTM) has been developed based on ddPCR with preselected SNPs, which enables measurements of fractional abundance (%) and absolute concentration (cp/ml). The decentralized assay showed a high correlation with the centralized % dd-cfDNA results (r = 0.96). Significantly elevated absolute dd-cfDNA levels (cp/ml) were found in patients with acute or chronic antibody mediated rejection (ABMR), DSA negative patients with microvascular inflammation or BK-virus nephropathy. Low-grade T-cell-mediated rejection (TCMR) (IA) without vascular injury was not well detected in plasma in contrast to high-grade TCMR. The diagnostic performance of plasma dd-cfDNA for rejection detection is in general very good for kidney, heart, lung and liver transplant recipients (range of mean values: AUC-ROC 0.79 - 0.95, sensitivity 66 - 90 %, specificity 76 - 88 %, PPV 33 - 63 %, NPV 89 - 100 %).
Biography
Michael Oellerich, MD, HonMD, FAACC, FAMM, FFPath (RCPI), FRCPath, is a chemical pathologist and currently a Distinguished Research Professor at the Department of Clinical Pharmacology, Medical Faculty (UMG) of the George-August University, Göttingen, Germany. From 2012 to 2017 he had an appointment as Lower Saxony Professor of Clinical Chemistry. He was Chairman of the Department of Clinical Chemistry/Central Laboratory at UMG (1991-2012), and Dean of the Faculty of Medicine. He served as
President of national and international professional organizations (IATDMCT, DGLM, DGKL, WASPaLM). He was Editor-in-Chief of Therapeutic Drug Monitoring (2003-2018) and currently is Associate Editor of this journal. His current research interests are in the field of therapeutic drug monitoring (e.g. cfDNA in cancer and donor-derived cell-free DNA in transplantation). He has authored more than 500 publications and has
received various awards (e.g. Ludolf-Krehl Award, IATDMCT Charles Pippenger Award, WASPaLM Medal of Honor, WASPaLM Gold-Headed Cane, Sign of Honor, Professor Jordan Todoroff (BSCL). F. McCreary Prize for Interprofessional Teamwork, Genome Canada Transplant Consortium, University of British Columbia, UBC Health, Vancouver (Canada) 2022, Claus Roxin Award for Outstanding Contributions to International Liberal Academic Exchange, Munich 2023).
Prof Klemens Budde
Chief Of Kidney Transplant Medicine
Charité Universitätsmedizin Berlin
Clinical utility of dd-cfDNA testing
Abstract
ABMR remains a major therapeutic challenge and causes about 20 - 30 % of allograft failures. Dd-cfDNA has demonstrated clear clinical utility for early ABMR detection, in particular in DSA+ patients. A recent randomized clinical trial showed that longitudinal dd-cfDNA monitoring in DSA positive kidney transplant recipients significantly shortened the time to diagnosis (2.8 months in the intervention group with dd-cfDNA guided biopsy vs. 14.5 months in the control group with clinician guided biopsy) with excellent test characteristics. In contrast no significant elevation of dd-cfDNA was seen in patients with recurrent IgA nephropathy (IgAN), or calcineurin inhibitor nephrotoxicity. New treatment options using CD38-targeting monoclonal antibodies (CD38 mAB) are currently evaluated and dd-cfDNA has been successfully used as a companion biomarker in patients with chronic ABMR treated with a CD38 mAB. Based on currently available evidence Medicare provides coverage for dd-cfDNA routine testing in the US. In summary, dd-cfDNA facilitates a personalized immunosuppression, enables early detection of ABMR together with monitoring treatment success of a CD38 mAb and provides another tool for cost-effective transplant recipient surveillance with the potential to reduce premature graft loss.
Biography
Klemens Budde MD is Deputy Medical Director of the Department of Nephrology and Medical Intensive Care at Charité Universitätsmedizin Berlin, Germany, where he holds an endowed professorship for pharmacodynamics on immunosuppression after kidney transplantation since 2006. After receiving his medical degree from Tübingen University, Germany, Dr. Budde completed training in Nephrology at Friedrich-Alexander University, Erlangen-Nürnberg and subsequently at the Charité, Humboldt University. Dr. Budde also completed a postdoctoral fellowship in Nephrology at Yale University, New Haven, Connecticut, USA. He possesses a board certification in Internal Medicine, in Nephrology and a Certification for Hypertensiology. He is a board member in several commissions of national and international societies.
Professor Budde had received the Hans-U.-Zollinger Research Prize of the German Association for Nephrology in 2004 for outstanding achievement in his field. In 2018 he became working group chair for Medicine and Care of the platform “Lernende Systeme”, Germany´s platform for artificial intelligence.
Prof. Budde’s main research interests include kidney transplantation, eHealth and genetic diseases of the kidney. He is the author or co-author of more than 450 journal articles, and has lectured nationally and internationally on numerous topics in transplantation.
Geoffrey Bien
Director, Product Market Development
Oncocyte
Novel decentralized dd-cfDNA Testing
Abstract
Donor-derived cell-free DNA (dd-cfDNA) has demonstrated strong diagnostic and clinical utility in transplant rejection monitoring. As applications continue to expand into longitudinal surveillance and therapeutic response monitoring, the need for rapid, decentralized access to results is increasing. Technologies like digital PCR (dPCR) empower researchers to develop assays with lower detection limits, direct quantitation, and results within a single day turnaround, all features which are crucial for decentralizing access to dd-cfDNA testing.
In this session, we introduce GraftAssure™, a ddPCR-based test kit designed for local laboratory implementation, delivering same-day turnaround time and dual quantification of dd-cfDNA (absolute and fractional). Developed on the Bio-Rad QX600 dPCR system and leveraging preselected SNPs of high global minor allele frequency, GraftAssure enables more timely clinical insights and expands access to this critical biomarker beyond centralized reference labs—supporting a future where precision transplant care is both accessible and actionable at the point of need.
In this session, we introduce GraftAssure™, a ddPCR-based test kit designed for local laboratory implementation, delivering same-day turnaround time and dual quantification of dd-cfDNA (absolute and fractional). Developed on the Bio-Rad QX600 dPCR system and leveraging preselected SNPs of high global minor allele frequency, GraftAssure enables more timely clinical insights and expands access to this critical biomarker beyond centralized reference labs—supporting a future where precision transplant care is both accessible and actionable at the point of need.
Biography
Geoffrey Bien leads Product Market Development at Oncocyte, where he specializes in bringing innovative molecular diagnostics to market with a focus on transplant and oncology applications. With a background in genetics and a passion for decentralizing access to high-impact biomarkers, Geoffrey plays a key role in translating complex assay technologies into accessible, clinically actionable tools. At IATDMCT 2025, he will present GraftAssure™, a novel ddPCR-based dd-cfDNA testing solution designed for local lab implementation—advancing the vision of same-day, decentralized transplant surveillance worldwide.
