numares announces FDA 510(k) Submission of AXINON System®, a NMR platform for metabolomics-based, AI-driven Diagnostics
24.3.2021 14:00:00 EET | Business Wire | Press release
Leading NMR diagnostics company numares AG today announced that the company made a 510(k) submission to the U.S. Food and Drug Administration (FDA) for its AXINON® IVD System, a NMR-platform for AI-driven, metabolomics-based diagnostics. If cleared, AXINON® would become the first NMR-based clinical laboratory system using AI-evaluated metabolic data. Several multi-marker assays for AXINON® will cover numerous unmet medical needs, in order to prevent, diagnose and treat disease.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210324005057/en/
numares AXINON® IVD System: The AI-driven AXINON® Software, in combination with advanced NMR technology, refined by numares' proprietary Magnetic Group SignalingTM, allows metabolomics-based precision diagnostics by implementation of various numares' tests, e.g. to identify early kidney rejection in post-transplant surveillance, assess kidney function by improved determination of glomerular filtration rate (GFR) and risk for cardiovascular disease (CVD). (Photo: Business Wire)
The clearance of AXINON® would bring a novel diagnostic approach to clinical laboratories, the combination of several metabolic biomarkers, so-called metabolite constellations, analyzed by advanced nuclear magnetic resonance (NMR) technology and evaluated by numares’ proprietary, AI-driven AXINON® diagnostic software.
"This U.S. regulatory filing for its diagnostics platform is an important milestone for numares," said Winton Gibbons, President - US and co-Chief Executive Officer of numares. “After entering into collaborations on joint diagnostics development with analytical instrumentation and solution provider Bruker Corporation in January 2021, and with Mayo Clinic Laboratories in 2019, this FDA submission is the first step in our common endeavor to bring NMR diagnostics into routine clinical use, and make metabolomics-based diagnostics accessible to the patients.”
numares is currently developing multi-marker algorithms for several diagnostic tests on the AXINON® IVD System. These include AXINON® GFRNMR to reliably assess kidney function by improved determination of glomerular filtration rate (GFR). numares expects to submit this test to the FDA also in the first half 2021. The third assay AXINON® renalTX-SCORE® is intended to reliably identify early kidney rejection in post-transplant surveillance, and be submitted to the FDA in 2022. Further multi-marker tests are in development, e.g., for liver disease, cancer detection, and multiple sclerosis.
Dr. Maulik Shah, numares’ Medical Director comments: “AXINON® provides clinical laboratories with a powerful technology that leverages the information-rich metabolome with artificial intelligence to give healthcare professionals new insights into disease diagnosis and management for improved patient outcomes. At the same time, automation capabilities, excellent precision, easy operability will allow easy adaption of the FDA-cleared system by clinical laboratories and will make AXINON® an indispensable routine diagnostic tool in precision medicine.”
“The 510(k) submission of our AXINON® System is an important step and prerequisite to further strengthen commercialization of numares’ products in the United States”, concludes Dr. Volker Pfahlert, co-CEO of numares and chairman of the executive board. “Metabolic disorders are a rapidly increasing problem and major challenge to today’s healthcare systems. Patients will benefit from our approach to consider the patient's metabolome with sophisticated algorithms. Once cleared by the FDA, we believe AXINON® has the potential to meaningfully improve health outcomes and quality of life for millions of patients.”
The AXINON® System consists of AI-based AXINON® Software, ready-to-use AXINON® kits, and an advanced NMR technology, refined by numares’ proprietary Magnetic Group SignalingTM to ensure highly standardized and automated processing of serum or urine samples in high-throughput.
About numares
numares AG, based in Regensburg, Germany, is a fast-growing innovative diagnostics company that applies machine learning to metabolomics data to develop advanced analytical tests for high-throughput use in clinical diagnostics. The AXINON® System employs advanced nuclear magnetic resonance (NMR) spectroscopy to evaluate metabolic constellations. Magnetic Group Signaling (MGS® ) is a proprietary technology that enables NMR for highly standardized and rapid throughput testing. Metabolic tests stand as an important pillar in precision medicine to address unmet needs in cardiovascular, kidney, liver, and neurological diseases. You will find more information at https://www.numares.com/
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210324005057/en/
Contact information
numares
Christiane Proll
Tel.: +49 941 280 949-14
E-Mail:
christiane.proll@numares.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
SLB Launches ExaCT Electrical Downhole CT Control System24.8.2026 14:02:00 EEST | Press release
SLB (NYSE: SLB) today launched the ExaCT™ electrical downhole coiled tubing (CT) control system, an advanced intervention platform that introduces real-time electrical control to coiled tubing operations. By replacing pressure-dependent hydraulic actuation with electrical communication, power delivery and telemetry, the ExaCT system gives operators greater visibility, precision and control, helping improve intervention execution and reservoir access. The ExaCT system combines electrical power, telemetry and downhole measurements to enable communication with, actuation of and verification of downhole tools throughout an intervention. Continuous communication across the toolstring enables on-demand tool actuation across a wide range of intervention applications, including extended-reach and multilateral wells. The increased precision and control provided by the system help operators optimize reservoir access, improve production performance and maximize recovery. "Operators are asking int
Wolters Kluwer Transforms Trusted Legal Content Into Structured, AI-Ready Intelligence That Powers the Next Wave of Legal AI24.8.2026 14:01:00 EEST | Press release
Wolters KluwerLegal & Regulatory today announced the next evolution of Libra by Wolters Kluwer, its all-in-one Legal AI Workspace. By transforming authoritative legal sources, expert commentaries, and practical guidance into structured legal intelligence, Wolters Kluwer is making the relationships across the full breadth of its expert legal sources more explicit. This will enable deeper contextual research, more comprehensible answers, and workflow-ready results across legal work. Following the integration of Wolters Kluwer content into the Libra AI workspace in the first half of 2026, laws, rulings, expert commentaries, and practical guidance will now be linked to one another and to the matter at hand, creating a connected knowledge graph of expert-curated and authoredlegal knowledge that AI can reason over. For customers, this means research that surfaces the right authority faster, answers with even clearer reasoning and sources, drafting guided by matter-specific context, and great
Daiichi Sankyo Appoints Markus Kosch to Lead Europe Business as Part of New Commercialization Organization24.8.2026 11:00:00 EEST | Press release
Daiichi Sankyo (TSE: 4568) today announced the appointment of Markus Kosch, MD, as Head of Europe Business, effective April 1, 2027. In this role, he will lead the company's European business within the new globally integrated Commercialization Unit and serve as General Manager of Daiichi Sankyo Europe GmbH, with legal responsibility for the company in Europe. The appointment reflects the next phase of growth of Daiichi Sankyo under its Five-Year Business Plan and the establishment of a new Commercialization Unit. Within this new structure, Markus Kosch will bring together the Oncology and Specialty businesses in Europe under one integrated leadership model to help bring innovative medicines to more patients across the region. For the past five years, Markus Kosch has led the Daiichi Sankyo Oncology Business Division in Europe and Canada, overseeing a period of significant growth and preparing the organization for an increasingly expanding oncology portfolio. Prior to joining Daiichi S
European Commission Approves DAYBU ® (trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms of Rett Syndrome in the European Union24.8.2026 10:01:00 EEST | Press release
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the European Commission (EC) has granted marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older, making it the first and only treatment approved for Rett syndrome in the European Union (EU). “The approval of DAYBU marks a significant milestone for the Rett syndrome community in the EU and advances our mission to bring this innovative treatment to patients and families who have long faced a profound unmet medical need,” said Catherine Owen Adams, Acadia’s Chief Executive Officer. “For people living with Rett syndrome, a devastating rare neurodevelopmental disorder, there have been no approved treatment options in the EU. We are proud to make DAYBU available and look forward to supporting patients, caregivers, and healthcare providers gain access to treatment." The DAYBU marketing authorization in the EU is prim
ORZEYFUL (oveporexton) Approved in Japan as the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 124.8.2026 09:36:00 EEST | Press release
Takeda (TOKYO:4502/NYSE:TAK) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the use of ORZEYFUL (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. ORZEYFUL is a first-in-class oral orexin receptor 2 (OX2R) agonist and the only medicine indicated in Japan to treat the disease holistically rather than individual symptoms. The discovery of this new class of medicine originated in Takeda's laboratories in Japan. Takeda is proceeding with launch preparations and expects to make ORZEYFUL available as quickly as possible. “Our discovery of the first orexin agonist is a successful representation of Japan-originated science that will directly impact people around the world living with narcolepsy type 1,” said Julie Kim, president and chief executive officer of Takeda. “With the potential to redefine narcolepsy type 1 care, ORZEYFUL is the first validation of our broader orexin strategy, demonstrating how scientifi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom