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.
AXINON® renalTX-SCORE®-U100* is a urine based test using metabolomics and Magnetic Group Signaling (MGS®) technology to support the diagnosis of a kidney transplant allograft rejection. This non-invasive test analyzes and evaluates a metabolite biomarker constellation previously identified and validated.
Thus, this test allows for close monitoring of the transplant allograft, is non-invasive for greater patient compliance and comfort and does not require potential graft damaging biopsy. In the course of follow-up care and in conjunction with clinical context, AXINON® renalTX-SCORE®-U100 can identify graft rejection reactions and clarify the cause of non-specific symptoms.
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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 1.5 million tests have been performed worldwide based on numares’ technology.