DCMT (London), Honorary Member of the European Society for Paediatric Nephrology
According to the KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease, the severity of CKD should be classified based on glomerular filtration rate (GFR), etiology and albuminuria. The gold standards to determine measured GFR are inulin and other exogenous substances [1, 2, 3]. These mGFR methods are expensive, invasive, time-consuming and very limited for routine use in out-patient settings. Therefore, GFR is mostly estimated by endogenous creatinine and/or cystatin C (eGFR) .
However, both substances have shown to be imprecise. Their results depend on chemical methods and on patient’s individual features like age and muscle mass. More than 50 eGFR equations were tested without great success to compensate for these inaccuracies, and recent recommendations proposed their parallel use with a new equation.
In conclusion, measuring eGFR is still regarded to be the weak link in the diagnostic chain of renal diseases . Based on these facts, we concluded that there is a need for a test system that combines precision of mGFR with robustness of a new method, thus, allowing to compare the results between different laboratories and varying groups of patients.
RENUM is a retrospective multi-center observational study
Biobanked serum samples of patients with broad spectrum of primary renal diseases and degrees of renal impairment
The scientific literature indicates that there is a connection between increasing/ decreasing concentrations of endogenous blood metabolites and the GFR. To establish a combination of endogenous metabolites with creatinine to a metabolite constellation reflecting GFR, numares uses its precise, fast and flexible analytical AXINON® System, which allows simultaneous detection of metabolites in a highly reproducible single analytical step.
The association of endogenous serum metabolites with GFR will be tested. Quantitative NMR signals of both, literature reported candidates and proprietary metabolic markers, will be correlated with mGFR reference data. Candidates significantly associated with GFR will be used to model renal clearance based mGFR.
The diagnostic performance (trueness and precision) of the obtained model(s) will be tested in a further, independent sample set (not used for discovery or modelling).
Our efforts resulted in a novel, simple blood test for estimating GFR that is available for clinical routine since 2019: AXINON® Clearance Check*.
AXINON® Clearance Check* allows a deeper insight into kidney pathophysiology. It provides a metabolite panel with serum concentrations of eight metabolites that are associated with kidney function and also allows conclusions to be drawn on renal and extra-renal co-morbidities.
1. Smith, H.W., The kidney: Structure and function in health and disease. Oxford University Press Inc, New York, 1951.
2. National Kidney, F., K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis, 2002. 39(2 Suppl 1): p. S1-266.
3. Stevens, L.A. and A.S. Levey, Measured GFR as a confirmatory test for estimated GFR. J Am Soc Nephrol, 2009. 20(11): p. 2305-13.
4. Kemperman, F.A., R.T. Krediet, and L. Arisz, Formula-derived prediction of the glomerular filtration rate from plasma creatinine concentration. Nephron, 2002. 91(4): p. 547-58.
5. Johnson, D. and I. Caring for Australians with Renal, The CARI guidelines. Evaluation of renal function. Nephrology (Carlton), 2005. 10 Suppl 4: p. S133-76.
*numares’ products are not yet available for sale within the United States; they have not yet been approved or cleared by the U.S. Food and Drug Administration.
5th - 10th November, 2019
Washington, DC, USA
numares presented two posters at the ASN Kidney Week about metabolomics based assessment of kidney function using a multi-parametric metabolite constellation to determine glomerular filtrations rate (GFR(NMR)).
Quantitative evaluation of the diagnostic accuracy (AUC value, sensitivity, and specificity) of AXINON® renalTX-SCORE-U100® for the detection of acute renal allograft rejections
“A non-invasive diagnostic test for close-monitoring of kidney transplant patients and minimizing the number of potential graft-harming biopsies for earliest therapy intervention to preserve the kidney“,
Eva-Maria Huber, Study Manager Clinical Development, numares AG
Kidney transplantation is the treatment method of choice for patients with terminal kidney failure . Transplant patients require frequent follow-up examinations to detect potential complications at an early stage. Therefore, biopsies are performed during aftercare. They are generally considered to be safe, but it remains an invasive procedure with a risk...
Development and Evaluation of a metabolite constellation for the diagnosis of bladder cancer in patients with persistent microhaematuria.
“A minimal invasive diagnostic test for a reliable detection of bladder cancer.“
Amauri G.S. Santamaría, Study Manager Clinical Development, numares AG
Urinary bladder cancer (BCa) is a malignant tumour that usually develops in the mucous membrane (urothelial carcinoma) of the bladder. The symptoms are relatively unspecific. One of the earliest cardinal symptoms of BCa is microscopically detectable haematuria, so-called microhaematuria, . However, microhaematuria commonly has benign causes, such as infection, benign prostate enlargement or...
Development and validation of a metabolite constellation in serum for early detection of hepatocellular cancer.
“A diagnostic screening test for early detection of hepatocellular cancer to supplement abdominal sonography in HCC surveillance.“
Dr. Sebastian Hoeckner, Study Manager Clinical Development, numares AG
Hepatocellular carcinoma (HCC) is an aggressive tumor of the liver with annual incidence of 1-6% in at risk patients with liver cirrhosis [1, 2]). Most patients have symptoms only in advanced stage HCC, impeding early detection of the tumor. The 5-year survival rate is <10% if HCC is diagnosed after symptoms...
Development and Validation of an NMR-based metabolite constellation that early indicates the transition of relapsing-remitting (RRMS) to secondary progressive multiple sclerosis (SPMS).
“A serum-based test for early diagnosis of the RRMS-to-SPMS transition to allow timely therapy adjustment”
Dr. Eric Schiffer, Head of Clinical Development, numares AG
Multiple sclerosis (MS) is considered to be an immune-mediated disease in which the body’s own defence cells attack the central nervous system. MS involves inflammatory and neurodegenerative processes that damage the insulating myelin sheaths of nerve fibers and the nerve cells themselves. While about 10-15% of patients begin the disease with primary progressive MS (PPMS) showing continuously worsening of symptoms from disease onset, the majority of patients are initially diagnosed...