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
Visa Opens the Door to AI-Driven Shopping for Businesses Worldwide8.4.2026 19:00:00 EEST | Press release
Visa Inc. (NYSE: V) today unveiled Intelligent Commerce Connect, a new solution that makes it easier for businesses to connect to and participate in AI-powered commerce. Intelligent Commerce Connect acts as a network, protocol, and token vault-agnostic ‘on ramp’ to agentic commerce for agent builders, merchants, and enablers. As consumers increasingly rely on AI agents to make purchases, businesses – whether they are building agents, selling to them, or processing transactions – need a simple way to get started. Intelligent Commerce Connect, part of the Visa Intelligent Commerce portfolio, meets that need. Through a single integration via the Visa Acceptance Platform, Intelligent Commerce Connect enables secure payment initiation, tokenization, spend controls, and authentication. The solution integrates both Visa Intelligent Commerce APIs, which are used to process agent purchases using Visa cards, and other networks’ APIs, allowing agents to pay with both Visa and non-Visa cards*. Thi
Andersen Consulting Strengthens Digital Transformation Capabilities Through Kyanon Consulting Collaboration8.4.2026 16:30:00 EEST | Press release
Andersen Consulting enhances its platform through a Collaboration Agreement with Kyanon Consulting, a Vietnam-based technology consulting firm known for delivering large-scale digital transformation solutions. Founded in 2025, as an arm of Kyanon Digital, Kyanon Consulting provides end-to-end digital and technology services to retail, banking and finance, and manufacturing organizations seeking to modernize operations, improve customer engagement, and accelerate growth. The firm delivers solutions across digital strategy, enterprise and product development, system integration, workflow automation, advanced analytics, and AI-driven insights for customer experience. “At Kyanon Consulting, our mission is to create digital impact that truly matters,” said Tai Huynh, founder of Kyanon Consulting. “We equip clients with the tools, insights, and innovation needed to strengthen resilience and unlock new opportunities. Collaborating with Andersen Consulting allows us to bring our capabilities t
Sumitomo Corporation, SMBC Aviation Capital, Apollo and Brookfield Complete the Acquisition of Air Lease Corporation8.4.2026 16:13:00 EEST | Press release
Sumitomo Corporation, SMBC Aviation Capital, Apollo-managed funds (“Apollo”) and Brookfield today announced that they have completed the previously announced acquisition of Air Lease Corporation (“Air Lease”) and have renamed the business Sumisho Air Lease Corporation (“Sumisho Air Lease”). This transformational transaction improves the financial position of the business with long term support and aviation expertise from co-investors Sumitomo Corporation, SMBC Aviation Capital, Apollo and Brookfield. Sumisho Air Lease’s strong foundation as an established aircraft lessor, supported by SMBC Aviation Capital’s industry‑leading capabilities as servicer, creates a platform with the scale and financial strength needed to meet the fast‑changing and increasingly complex requirements of airline customers. Sumisho Air Lease will also benefit from the deep expertise and long-standing commitment that both Sumitomo Corporation and SMBC Aviation Capital bring to the global aviation leasing sector.
Sitetracker Launches Scout, an Agentic AI Platform Purpose-Built for Critical Infrastructure8.4.2026 16:00:00 EEST | Press release
Sitetracker, the leading Asset Lifecycle Management platform for critical infrastructure, today announced the launch of Scout, its new Agentic AI platform designed to help infrastructure owners, operators, and contractors gain deep insights and drive automation within their operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260408923336/en/ Scout, ready for real work As your AI analyst and agent, Scout is ready to work on day 1. Scout provides clarity when decisions are forming and momentum when action is required. It surfaces risk, synthesizes information, and helps accelerate execution by connecting data and driving action. Scout creates operational intelligence and turns it into action all in a secure environment that protects data sovereignty. “Our customers are looking to create compounding competitive advantages,” said Giuseppe Incitti, Chief Executive Officer of Sitetracker. “Scout delivers by providing easy t
Westinghouse Hosts Annual VVER Fuel Forum with Customers8.4.2026 16:00:00 EEST | Press release
Westinghouse and MVM Paks Nuclear Power Plant (NPP) recently co-hosted the VVER Fuel Forum in Budapest to share insights and plans for the continued deployment of VVER-1000 and VVER-440 fuel in operating reactors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260408646373/en/ Participants to the VVER Fuel Forum Péter János Horváth, CEO of MVM Paks, welcomed all the participants, highlighting that Hungary is ending two decades of single supplier fuel dependency thanks to the agreement recently signed with Westinghouse to supply the VVER-440 NOVA E-6 fuel design. Six customers presented the progress made and positive outcomes achieved in the past years with the introduction of Westinghouse fuel into mixed cores with resident fuel in their reactors: Energoatom has extensive experience with Westinghouse VVER-440 and VVER-1000 fuel, currently used in the nine reactors in operation. Ukraine will be the first country to operate en
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