Olaris is pleased to announce the publication of clinical data in iScience demonstrating the utility of its non-invasive myOLARIS®-KTdx urine test in kidney transplant patients. The study shows that metabolite signatures can accurately detect and differentiate types of kidney graft injury, offering clinicians a powerful tool to complement biopsies, reduce unnecessary procedures, and guide individualized immunosuppression management.
FRAMINGHAM, Mass., Sept. 8, 2025 /PRNewswire-PRWeb/ -- Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning for the discovery and development of its myOLARISTM diagnostics products, which aim to optimize treatments and outcomes for individual patients—today announced findings published in iScience1 that demonstrate the clinical validation and utility of their non-invasive myOLARIS-KTdx urine metabolite test to detect and differentiate kidney graft injury in kidney transplant patients.
Preventing kidney allograft loss remains a significant challenge. One in five patients will experience graft loss within five years and over half will lose their graft by 10 years2. To maintain stable renal allograft function and patient health physicians must balance immunosuppression to a level that prevents the patient's immune system from damaging the graft while also minimizing graft damage due to infection. Histology can give a definitive measurement of graft status, but biopsies are invasive, and histology may not always distinguish between types of graft injuries that require opposite adjustments in immunosuppression medication. In this study, Olaris shows that a urine metabolite signature serves as a non-invasive biomarker for the state of immunosuppression which could complement other clinical tools to help personalize clinical management decisions.
"There is a great need for non-invasive biomarkers to guide clinical management decisions, both in a surveillance setting and in cases of allograft dysfunction or indication biopsies that give inconclusive results. This study provides encouraging data that myOLARIS-KTdx can potentially reduce unnecessary biopsies and help clinicians fine-tune the dynamic course of immunosuppression", said Dr. Dirk Kuypers, senior author on the publication and Professor of Medicine and Chair of the Laboratory of Nephrology at the University of Leuven, Belgium.
As part of the study, retrospective urine samples from 102 patients were used to further validate NMR-based metabolite signatures to detect and differentiate a stable graft from graft injury including borderline rejection and active rejection due to underimmunosuppression and PVAN due to overimmunosuppression (0.867 AUC, 0.843 26 accuracy, 0.843 sensitivity, and 0.843 specificity). The signature has been validated in an independent retrospective validation cohort of 43 patients (0.878 AUC, 0.864 accuracy, 0.957 sensitivity, and 0.762 specificity). All training and validation samples had matched surveillance and/or indication biopsies.
The study demonstrates the role of myOLARIS-KTdx in the surveillance setting to help avoid unnecessary biopsies and detect graft injury missed by routine tests. In clinical application the assay could mitigate the chance of incorrect treatment, facilitate individualization of maintenance immunosuppressive therapy by using this urine test and add insight to inconclusive biopsies.
"These promising results highlight the potential application of urine metabolomic signatures as a powerful barometer of immunosuppression. Building on this momentum, we have already completed additional validation studies in expanded patient cohorts, with results to be published soon, further reinforcing the role of myOLARIS-KTdx in guiding patient care." said Dr. Elizabeth O'Day, CEO/CSO of Olaris.
To read the publication, go here. https://doi.org/10.1016/j.isci.2025.113331
References:
- Dong, C. et al. Urinary Metabolite Signatures to Detect and Differentiate Graft Injury in Kidney Transplant Patients. iScience 113331 (2025) doi:10.1016/j.isci.2025.113331.
- Davis, S. & Mohan, S. Managing Patients with Failing Kidney Allograft Many Questions Remain. Clinical Journal of the American Society of Nephrology 17, 444–451 (2022).
Media Contact
Ruthy Salde, Olaris, Inc, 1 6179814784, [email protected], www.myolaris.com
SOURCE Olaris, Inc
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