Numares launched its urine test for kidney rejection, the first such test that uses a metabolic biomarker network instead of a single biomarker to diagnose organ rejection after a kidney transplant. The noninvasive test could reduce the need for invasive kidney biopsy following transplant.
The renalTX-SCORE test is CE-marked and runs on numares’ Axinon in-vitro diagnostics system. Unlike traditional diagnostics, the test uses a multi-metabolite biomarker network, rather than evaluating a handful of biomarkers, the company said in a statement.
The patient provides a urine sample, which then goes through nuclear magnetic resonance (NMR) spectroscopy. The test analyzes the NMR spectrum produced. If the result shows that the patient is experiencing acute rejection, a biopsy will be done to confirm the result.
The current standard for diagnosing acute rejection is an invasive kidney biopsy. The urine test could cut down on the number of biopsies for kidney transplant patients.
"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, of the Regensburg University Hospital in Germany, who collaborated with numares to develop the test. “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.”
The test could lead to more frequent monitoring of kidney transplant patients, as it is cheaper than biopsy in addition to being noninvasive, he said.
Meanwhile, Natera has partnered with the University of California, San Francisco to study DNA markers for kidney transplant rejection in the hopes of creating a noninvasive diagnostic. And in 2014, the FDA greenlighted Plexision’s blood test to predict the risk of liver or intestine rejection in pediatric patients.