End-stage renal disease (ESRD) occurs when the kidneys lose their ability to filter the blood and remove harmful substances through the production of urine.
Loss of this function results in hemodynamic changes and accumulation of metabolic waste, leading to high blood pressure, uremia and kidney failure.
When a patient loses about 90% of kidney function, dialysis is the next step. If dialysis stops working effectively, kidney transplantation is needed.
Kidney transplantation improves quality of life, but also includes a number of health risks, including rejection of the donor kidney. Rejection is very serious, and clinicians work very hard to preserve the transplanted kidney.
Currently, lacking clear rejection-associated biomarkers, a biopsy is required with histological analysis to assess whether the kidney is in the process of being rejected.
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 new kidney function.
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. During transplantation follow-up care, AXINON® renalTX-SCORE®-U100 can provide information on non-specific symptoms by distinguishing graft rejection reactions.
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Nuclear magnetic resonance (NMR) spectroscopy is a proven and highly accurate test technology that assesses a variety of compounds at a molecular level.
Our FDA-cleared AXINON® System is the core technology platform we use to develop diagnostic tests for illnesses stemming from metabolic dysfunction, including chronic heart, kidney and liver diseases.
This system incorporates diagnostic testing algorithms into nuclear magnetic resonance (NMR) spectroscopy for precise results.
To date, more than 3 million tests have been performed worldwide using 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