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 with relapsing-remitting MS (RRMS) [1,2]. In RRMS, patients experience attacks of neurological symptoms (relapses) followed by periods of complete or partial remission. Most RRMS patients will eventually transition to a secondary progressive course (SPMS) with continuous worsening of symptoms and accumulation of disability. The RRMS-to-SPMS transition requires a change in therapy as most MS medications are not effective in SPMS . Currently, there is no diagnostic test for SPMS and clinical diagnosis of SPMS transition is difficult and time-consuming, as it requires retrospective evaluation of neurological exams and results from magnetic resonance imaging (MRI) of the brain of the last 12 months . A diagnostic test that reliably identifies patients at early transition from RRMS to SPMS would improve management and long-term outcome of MS patients.
Two-center, prospective, observational study
Serum samples from patients with RRMS or SPMS
Brain MRI in combination with retrospective evaluation of disease course and disability in neurological exams
University of Oxford and numares started a joint development program to develop metabolomics-based diagnostics tests in multiple sclerosis. In previous work, University of Oxford has discovered biomarkers for discriminating RRMS from SPMS patients using nuclear magnetic resonance (NMR)-based analysis of blood samples . Oxford University and numares are currently conducting a prospective observational study to validate the identified biomarkers and combine them to a metabolite constellation that reliably indicates early transition from RRMS to SPMS. numares provides its Magnetic Group Signaling (MGS®) technology and NMR-based AXINON® IVD system to translate the biomarker constellation into an in vitro-diagnostic (IVD) test.
In 2017, Oxford University and numares initiated a prospective observational study for validation of previous work.
1. Lublin, F.D., et al., Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology, 2014. 83(3): p. 278-86.
2. Multiple Sclerosis Society. Types of MS. www.mssociety.org.uk/what-is-ms/types-of-ms
3. Shirani A, Okuda DT, Stuve O. Therapeutic advances and future prospects in progressive forms of multiple sclerosis. Neurotherapeutics 2016; 13: 58–69.
4. Dickens, AM, et al. A type 2 biomarker separates relapsing-remitting from secondary progressive multiple sclerosis. Neurology 2014. 83:1492-9
Development and validation of an NMR based metabolite constellation determining glomerular filtration rate for a more accurate picture of the underlying kidney function.
“The numares‘ metabolomics approach bears the innovative und non-invasive potential to determine severity and complexity of CKD without using eGFR equations based on creatinine and cystatin C. Furthermore, the metabolite panel offers chances for studying CKD induced co-morbidities.“,
Professor Emeritus Jochen Ehrich, MD, 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...
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...