NEW YORK (360Dx) – Numares confirmed on Wednesday that its test for diagnosing kidney rejection has received CE-IVD marking. The firm has launched it in Europe.
Called renalTX-Score, the test is the first to be available worldwide that evaluates a metabolic biomarker network, rather than single biomarkers or tissue biopsy for diagnosing acute rejection following a kidney transplant, Numares said.
From a urine sample, an NMR spectrum is created, and then evaluated using renalTX-Score. If it indicates a patient is experiencing acute renal rejection, the person would be referred for biopsy for confirmation testing, or for therapeutic intervention.
Numares noted that the current diagnostic standard for acute rejection is kidney biopsy, which can damage the transplant, as well as cause discomfort and stress for the patient. It is also expensive.
The test is available as part of Numares' Axinon IVD system. RenalTX-Score was developed in collaboration with Bernhard Banas, head of the transplant center at the Regensburg University Hospital in Germany.
Numares Chairman Volker Pfahlert said in a statement that renalTX-Score can be "seamlessly integrated into clinical routine, is easy to handle, and delivers fast results. It should therefore be part of the standard repertoire of follow-up checkups of every transplant center in Europe."Â