Numares AG, Regensburg, Germany, has announced the global launch of Clearance Check, the latest test in the company’s Axinon family of modular, software-based clinical diagnostics. The new test employs a groundbreaking method for the accurate assessment of kidney glomerular filtration rate (GFR), and is the first simple serum test to achieve accuracy comparable to tracer-based plasma clearance methods.

The new test is based on a metabolite constellation analyzed by magnetic group signaling, which empowers nuclear magnetic resonance (NMR) spectroscopy. NMR spectroscopy is used to create a ‘numaric’ spectrum for the evaluation of metabolic constellations.

Volker Pfahlert

Volker Pfahlert, Numares.

“Our vision was to obtain a glomerular filtration rate value from a simple blood sample that is comparable to the much more involved plasma clearance method,” says Volker Pfahlert, PhD, CEO of Numares “With single biomarkers such as serum creatinine or cystatin C this remains especially challenging for patients with reduced kidney function. We overcame this hurdle by using a metabolic constellation of several biomarkers.”

In the United States, it is estimated that 30 million people suffer from impaired renal function. Ascertaining kidney function is important for managing patients with needs for a number of different medical issues, including late-stage complications in diabetes management, chronic congestive heart failure, and dosing of nephrotoxic drugs.

Jochen H.H. Ehrich

Jochen H.H. Ehrich, Dr. med. habil., Hannover Medical School.

“Estimating GFR with serum creatinine was considered to be the weak link in the diagnosis of renal dysfunction because of a lack of accuracy, mainly concerning stages 2 and 5 in chronic kidney disease,” explains Jochen H.H. Ehrich, Dr. med. habil., a professor emeritus and former head of the department of pediatric kidney, liver, and metabolic diseases at the children’s hospital of Hannover Medical School, and principal investigator for the Numares clinical study of renal function assessment by nuclear magnetic resonance-based metabolomics.

The new test was validated in a European multicenter clinical trial involving more than 200 patients at Hôpital Edouard Herriot, Sahlgrenska University Hospital, and University Medicine Charité. The time-consuming gold standard method of measuring GFR by tracer infusion was applied as a reference.

Intermediate results of the study were presented last year at the annual meeting of the American Society of Nephrology. The clinical data of the validation study will be published as a scientific paper.

Claus Botzler

Claus Botzler, Numares.

The metabolites used in the newly identified metabolic constellation reflect different aspects of underlying kidney pathology, such as metabolic acidosis or oxidative stress. By taking such markers into account, in addition to the GFR, physicians gain a much deeper insight into kidney function. Such molecular phenotyping will allow more precise and truly individualized treatments.

“The diagnosis of different stages of chronic kidney disease is often considered in isolation from the extent and prognostic significance of associated extra-renal metabolic comorbidities,” says Claus Botzler, COO at Numares. “Clearance Check is adding a new dimension to precision medicine, which until now was the domain of genetic testing.”

For further information, visit Numares.