By Diagnostics World Staff
April 4, 2017 | numares today announced the commercial launch of its new non-invasive test renalTX-SCORE for the diagnosis of kidney rejection. It is the first test available worldwide evaluating a metabolic biomarker network rather than single biomarkers or tissue biopsy for the diagnosis of an acute rejection reaction following a kidney transplant. renalTX-SCORE will be marketed in Europe as a CE-marked in-vitro diagnostic test (IVD).
numares’ approach utilizes the effects of a disease on the dynamics of human metabolism. Those effects can be recognized as specific changes in a biomarker network, generated by changes in the metabolic machinery caused by the disease. The renalTX-SCORE test, which is available as part of numares’ AXINON IVD system, evaluates the status of a multi-metabolite biomarker network rather than quantifying just one or a few biomarkers as with more traditional diagnostics. A urine sample is obtained from the patient, an NMR spectrum is created, then evaluated by the test. If the result indicates that a patient may be experiencing an acute rejection reaction then the patient would be referred for biopsy to confirm the result or even for therapeutic intervention.
"This non-invasive diagnostic to identify organ rejection in kidney transplant patients, which we have successfully developed together with numares, can be used in outpatient follow-up care even before needle biopsy is performed,” said Bernhard Banas, Head of the Transplant Center at the Regensburg University Hospital in Germany, in a written statement. “renalTX-SCORE has the potential to reduce the number of biopsies, a procedure which reduces both patient discomfort and potential damage to the transplanted kidney. It can be performed more often due to being non-invasive and cost-effective.”