End-stage renal (or kidney) disease (ESRD) occurs when the kidneys lose their ability to filter the blood to remove harmful substances through the production of urine. Loss of this function results in hemodynamic changes and accumulation of metabolic waste leading to a number of clinical symptoms, such as high blood pressure or uremia and kidney failure. When about 90% of function is lost, the patient requires artificial filtration and mechanical removal of waste via dialysis and in worst cases kidney transplantations.
In individuals with ESRD who undergo a kidney transplant, the transplant improves quality of life but is associated with a number of health risks. Transplant rejection of the donor kidney has the most serious consequences and intense efforts are made to preserve the health and function of the donor kidney. Currently, in the absence of clear rejection associated biomarkers, biopsy of the kidney is required with histological analysis to assess if there is an ongoing rejection process. In contrast, close monitoring of metabolic biomarkers for kidney rejection offers opportunities for early intervention and may decrease the number of biopsies required to assess the health of the donor graft.
1. January to September 2018, information based on OPTN data as of November 4, 2018
AXINON® renalTX-SCORE®-U100 is a CE-marked urine test using metabolomics and Magnetic Group Signaling (MGS®) technology to support clinical decision making in the context of kidney transplant rejection. This non-invasive test analyzes and evaluates a metabolite biomarker constellation previously identified and validated.
The AXINON® renalTX-SCORE®-U100 allows for close kidney allograft health surveillance. It is non-invasive, suitable for outpatient monitoring to improve patient compliance and decreases the need for invasive, painful and expensive biopsy. In the course of follow-up care and in conjunction with clinical context, AXINON® renalTX-SCORE®-U100 can clarify non-specific symptoms by distinguishing graft rejection reactions.
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The AXINON® renalTX-SCORE®-U100 test is performed on the AXINON® System which produces high-quality, standardized NMR spectra based on numares’ Magnetic Group Signaling (MGS®) technology.
The combination of MGS® with the AXINON® technology platform allows for test-specific spectral analysis with highly-reproducible results. The system is easy to use with one-step sample preparation and ready-to-use reagents. The test system is fast and efficient with automation capabilities allowing short hands-on-time and high walk-away capability with a throughput of more than 175 samples per day.
To date, more than 2 million tests have been performed worldwide based on numares’ technology.
Atul K. Sharma Tom D. Blydt-Hansen
To accompany Banas et al., Time for a Paradigm Shift
M. Banas, S. Neuman, P. Pagel, F. J. Putz, G. Boehmig, J. Eiglsperger, et al.
A urinary metabolite constellation to detect acute rejection in kidney allografts
M. Banas, S. Neumann, J. Eiglsperger, E. Schiffer, F. J. Putz, S. Reichelt-Wurm, et al.
Identification of a urine metabolite constellation characteristic for kidney allograft rejection
Metabolomics Off J Metabolomic Soc, 14 (9) (2018), p. 116