Clinical Research. |Valued Cooperations. For Improved Diagnostics.

With over a decade of cutting-edge clinical research and development experience, both internally and with a diverse range of academic and commercial collaborators, Numares has gained a proprietary portfolio of several metabolite constellations and related expertise.

We endeavor to stay at the cutting edge of metabolomics solutions in the clinical diagnostics arena by continuously exploring and developing new and improved medically relevant products, approaches and techniques. Get to know Numares’ clinical research unit in this section.

Vision. |Precision Diagnostics.

Numares is an innovative diagnostics company, focusing on the discovery, development and the clinical integration of in-vitro diagnostic (IVD) tests that are based on metabolomics and our proprietary MGS® technology. Using these highly innovative approaches, we set out to establish IVD tests that meet current diagnostic challenges, improve patient care and easily fit into clinical routine.

Diagnostics relying on single biomarkers frequently fail to address medical needs that are still unmet today. Metabolomics offers the possibility to identify biomarker patterns in the metabolism, we call it metabolite constellations, whose dynamics and relation to each other allow non-invasive and reliable diagnostics, considering the complete individual features of the patient: just precision diagnostics.

Our clinical development unit focuses on the discovery and development of metabolite constellations for various clinical indications, including cancer diagnosis and staging, kidney transplant rejection and kidney function, multiple sclerosis and cardiovascular diseases.

With our AXINON® technology platform and associated diagnostic tests we offer the medical community a sophisticated feature for an improved risk prediction of diseases.

Mission. |Improve Patient Care.

We are committed to advance medical progress by diagnostic products in various indications, such as cardiovascular diseases, liver and bladder cancer, multiple sclerosis, kidney function and renal transplant rejection– all being rising health issues worldwide.

Our clinical development unit ensures, that the developed metabolite constellations are carefully evaluated in the clinical context. Our concepts of individual medical use cases derive from daily clinical practice where therapeutic decisions are based on various diagnostics along with additional patient information (anamnesis).

Therefore, we conduct our clinical studies to systematically record these relevant clinical data which serve as a basis for a scientifically sound developed IVD. By waiving external CROs, we retain control, avoid interface losses and thus remain flexible and adaptable in the choice of the respective study design. Furthermore the close collaboration throughout the course of the study allows a deeper understanding of the challenges in clinical routine and opens up the possibility of continuous improvement of our approach.

Competency. |Respectful collaborations.

The carefully designed studies on which our product developments are based are an essential and integral part of our research and development process. They would not be possible without the highly appreciated contributions of our valuable partners and collaborators.

It is our central concern to treat our collaborators with greatest respect not only to support their valuable work to the best of our knowledge, but also to make the implementation of clinical studies compatible with clinical routine shores. In order to succeed, we support our partners with concentrated strength and experience, providing:

  • Interdisciplinary team with a strong scientific and clinical background
  • Proven track of record in supporting IVD development with suitable clinical studies
  • Clinical expertise and compliance acc. to ISO 13485, GCP and IVD EU regulations
  • All-round support: study set-up, contracting and logistics
  • Management of regulatory affairs and ethical approval
  • Integrity, reliable and resilient commitments
  • Joint scientific dissemination

Our Success. |Innovative Diagnostic Products.

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

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...

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

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 [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

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 ManagerClinical 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

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...

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Project: MUSE – Multiple Sclerosis Biomarker Evaluation

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...

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