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
CAIRDAC Announces the Appointment of Raymond W. Cohen as Chairman of its Board of Directors24.9.2026 10:49:00 EEST | Press release
CAIRDAC, SA, a pre-revenue stage medtech company developing a leadless, self-powered cardiac pacemaker (Autonomous Leadless Pacing System), today announced the appointment of Raymond W. Cohen as chairman of its board of directors. “We are thrilled to welcome Mr. Cohen to the CAIRDAC board of directors,” said Edouard Fonck, Chief Executive Officer of CAIRDAC, “Ray’s extensive track record in leading, scaling and exiting medical technology companies will, no doubt, be invaluable as we advance this exciting project.” Mr. Cohen, an accredited public company director and accomplished medical technology executive, has over four decades of medtech industry experience. He was the co-founder and CEO of Axonics, Inc. (Nasdaq: AXNX) a global leader in implantable neuromodulation devices that completed its initial public offering in 2018. Under his leadership, Axonics was recognized as the fastest-growing technology company in North America generating over $1.2 billion in revenue in the four years
Glass Lewis and Clarity AI Join Forces to Integrate Sustainability, Governance and Stewardship24.9.2026 10:30:00 EEST | Press release
Glass Lewis and Clarity AI today announced their combination, merging Clarity AI’s advanced technology, deep sustainability data, AI analytics, and strong European market presence with Glass Lewis’ global expertise across corporate governance, proxy voting and investment stewardship. The strategic combination significantly expands the firms’ ability to serve European institutional investors and companies through enhanced local market expertise, broader sustainability capabilities and faster product development that addresses Europe’s evolving regulatory and stewardship requirements. The integrated platform fills a solutions gap as institutional investors increasingly seek to bring together investment analysis, sustainability, governance, engagement and voting rather than manage them through separate systems, datasets and workflows. At the same time, companies are continuously seeking a better understanding of how their institutional shareholders view their governance and sustainability
Wolters Kluwer integrates Libra AI workflows into monKEY for Belgian tax professionals24.9.2026 10:00:00 EEST | Press release
Wolters Kluwer Legal & Regulatory today announced the integration of Libra AI workflows in monKEY, its research platform for tax professionals in Belgium. The add-in of Libra by Wolters Kluwer enables customers to directly access Libra’s AI capabilities from the trusted research environment in monKEY, combining generative AI with tax research based on long-trusted expert content. “By integrating Libra into monKEY, we are taking another important step towards connected, AI-powered workflows for our customers,” said Rimco Spanjer, Vice President & Managing Director, Wolters Kluwer Legal & Regulatory Benelux. “We are bringing together the power of AI and the trusted, up-to-date tax content professionals rely on every day. This helps them reach relevant insights faster while staying connected to the underlying domain expertise.” The integration also marks an important milestone in the expansion of Libra by Wolters Kluwer beyond legal workflows, bringing trusted AI capabilities to tax profe
SES Advances Satellite Manufacturing Facility in Luxembourg24.9.2026 09:50:00 EEST | Press release
SES, a space solutions company, has commenced construction of a new satellite manufacturing facility in Kockelscheuer, Luxembourg, marking a major milestone in the company’s vertical integration and business model evolution. The facility will enhance SES’ ability to design, develop and manufacture critical satellite technologies, accelerating the deployment of next-generation satellite networks and secure communications solutions. It will also help create a hub for innovation and enable SES partners and ecosystem with opportunities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260923560183/en/ SES Advances Satellite Manufacturing Facility in Luxembourg The new facility in Kockelscheuer is at the center of Luxembourg’s effort to build and scale a dedicated Space Campus to stimulate New Space companies and industrial collaboration, and serve as a center for engineering, testing, manufacturing and assembly, accelerating devel
NTT DOCOMO BUSINESS Launches “Pro”, a New docomo business SIGN ® Offering for Large-Scale Global Connected Products24.9.2026 05:00:00 EEST | Press release
NTT DOCOMO BUSINESS, Inc. (formerly NTT Communications Corporation) announced today the launch of "Pro," a new offering in the docomo business SIGN®1 lineup, an IoT-focused Network as a Service (NaaS) with built-in security features. Designed to support the large-scale and global deployment of connected products, “Pro” helps customers manage and operate tens of thousands of IoT connections. The service will be available from March 2027. This new offering addresses the challenges of achieving more advanced operational management through the centralized management of domestic and international IoT connectivity, operational automation, and system integration, while also enhancing security. It will reduce the operational burden on customers while supporting the continued delivery of value through connected products and services. 1. Background In recent years, against the backdrop of labor shortages resulting from Japan’s declining birthrate and aging population, various industries, such as
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