|Project outline

MUSE – Multiple Sclerosis Biomarker Evaluation

Objective:
Development and Validation of an NMR-based metabolic 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 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 [3].  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 [1]. A diagnostic test that reliably identifies patients at early transition from RRMS to SPMS would improve management and long-term outcome of MS patients.

Study design:
Two-center, prospective, observational study

Material:
Serum samples from patients with RRMS or SPMS

Reference standard: 
Brain MRI in combination with retrospective evaluation of disease course and disability in neurological exams

Approach: 
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 metabolic biomarkers for discriminating RRMS from SPMS patients using nuclear magnetic resonance (NMR)-based analysis of blood samples [4]. Oxford University and numares are currently conducting a prospective observational study to validate the identified biomarkers and combine them to a metabolic 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.

Success:
In 2017, Oxford University and numares initiated a prospective observational study for validation of previous work. 

References:
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

 

 

Our Success. |Innovative Diagnostic Products.

Project: RENUM – Renal Function Assessment by Nuclear Magnetic Resonance based Metabolomics

Objective:
Development and validation of an NMR based metabolic constellation determining glomerular filtration rate for a more accurate picture of the underlying kidney function.

“A diagnostic test as precise as mGFR, as simple as eGFR, and fit for clinical routine“,
Dr. Eric Schiffer, Head of Clinical Development, numares AG

The glomerular filtration rate (GFR) is the most important parameter in assessing kidney function. The gold standard to determine GFR is inulin clearance [1, 2], but other substances have been explored for measuring GFR (mGFR) as well [3]. Although very precise, mGFR methods are expensive, time-consuming and therefore impractical in routine. Therefore, GFR is mostly estimated by a simple serum creatinine analysis (eGFR) [4]. However, serum creatinine levels strongly depend on patient’s individual features...

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Project: PARASOL – Detection of Renal Allograft Rejection by NMR-based Urine Metabolomics

Objective:
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“,
Dr. Eric Schiffer, Head of Clinical Development, numares AG

Kidney transplantation is the treatment method of choice for patients with terminal kidney failure [1]. 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...

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Project: BLADE – Bladder Cancer Detection using Metabolomic Evaluation of Urine and Blood

Objective:
Development and Evaluation of a metabolic constellation for the diagnosis of bladder cancer in patients with persistent microhaematuria.

“A minimal invasive diagnostic test for a reliable detection of bladder cancer.“
Dr. Eric Schiffer, Head of 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, [1]. However, microhaematuria commonly has benign causes, such as infection, benign prostate enlargement or...

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Project: HERMES – Hepatocellular Carcinoma Recognition by Metabolomics Analysis of Serum

Objective: 
Development and validation of a metabolic 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. Eric Schiffer, Head of 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...

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