Abstract: SA-PO0079
Methylation-Based Cell-Free DNA Assay for Early Detection and Monitoring of AKI
Session Information
- AKI: Clinical Diagnostics and Biomarkers
November 08, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Acute Kidney Injury
- 102 AKI: Clinical, Outcomes, and Trials
Authors
- Ranjit, Shanon, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia
- Boulter, Nicky R., Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia
- Murray, David Hugh, The University of Newcastle, Newcastle, New South Wales, Australia
Group or Team Name
- Garvan Genomics Platform.
Background
Acute kidney injury (AKI) affects up to 1 in 5 hospitalised patients and leads to high morbidity, mortality, and costs. Current diagnosis using serum creatinine lacks sensitivity and can delay treatment by up to 48 hours, risking irreversible damage. We have developed a highly sensitive methylation-based PCR assay to detect kidney-specific cell-free DNA (ks-cfDNA) in blood and urine for real-time AKI diagnosis.
Methods
We assessed ks-cfDNA levels in 10 heart transplant patients and 71 healthy controls. cfDNA was isolated from the sample, bisulphite-converted, and quantified by multiplex dPCR, and compared against sCr levels.
Results
Our assay detected >20-fold rises in ks-cfDNA immediately post-surgery in 8/10 patients, while sCr increased only after 48 hours (Fig. 1), enabling earlier AKI detection. The other 2 patients showed no AKI by either method. In 4/8 AKI patients requiring dialysis based on clinical criteria, a second ks-cfDNA peak was observed, indicating dialysis-related injury, missed by sCr due to its clearance by dialysis. This shows our assay can detect ongoing or recurrent injury even when sCr fails. No clinical action was taken for Patient 1, despite elevated ks-cfDNA, and the patient later developed kidney failure, highlighting the need for prompt response to early ks-cfDNA signals. Patient 2 had elevated pre-op ks-cfDNA levels, above the cohort mean, suggesting subclinical kidney stress and later had a complicated recovery, supporting ks-cfDNA as a prognostic marker of renal vulnerability.
Conclusion
This first-in-class ks-cfDNA assay enables earlier, more specific AKI detection, allowing real-time post-surgical monitoring and timely intervention. With sensitivity to just 2 cfDNA copies/ml of blood or urine, our assay offers a major advancement over current methods and can improve outcomes for an estimated 400 million AKI cases globally each year.
Funding
- Private Foundation Support