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
Venture Global Announces Final Investment Decision and Financial Close for Phase 2 of CP2 LNG13.3.2026 16:23:00 EET | Press release
Today, Venture Global, Inc. (NYSE: VG) is announcing a final investment decision (FID) and successful closing of an $8.6 billion project financing for the second phase of the company’s third project, Venture Global CP2 LNG (CP2). When combined with the Phase One financing for CP2 announced July 2025, this milestone represents the largest standalone project financing in the U.S. bank market.The transaction garnered enormous interest from the world’s leading banks, resulting in over $19 billion of commitments for Phase Two in addition to the previous $34 billion of commitments for Phase One, and required no outside equity investment. “We are extremely proud to have taken FID on the second phase of CP2, our third greenfield project, bringing Venture Global’s executed capital markets transactions to more than $95 billion,” said Venture Global CEO Mike Sabel. “The tireless dedication of our team has enabled us to reach five final investment decisions in less than seven years, positioning us
NIQ Launches Beta of New AI-Powered Analytical Capabilities in Ask Arthur13.3.2026 13:00:00 EET | Press release
NIQ (NYSE: NIQ), a global leader in consumer intelligence, has launched new AI-powered analytical capabilities in beta within Ask Arthur on the NIQ Discover platform. The expanded experience guides users through end-to-end analysis—helping them identify what matters in the data, understand why trends are occurring, and turn insights into clear, shareable narratives with recommended next steps. As organizations navigate increasing data complexity, the ability to move quickly from insight to action has become essential. Ask Arthur helps shorten analytical processes that once took days or weeks into minutes by surfacing the key drivers behind performance changes and generating decision-ready insights directly within Discover. By connecting analysis, explanation, and storytelling in a single experience, users can move seamlessly from understanding what is happening in the data to determining what to do next. “These new analytical capabilities represent an important step forward in how we b
Reply at NVIDIA GTC: Digital Twins and Physical AI Driving the Next Stage of Industrial Value Creation13.3.2026 12:24:00 EET | Press release
Reply [EXM, STAR: REY] will be present at NVIDIA GTC from 16 to 19 March 2026 in San Jose, California, showcasing how companies can optimise production and logistics processes, scale robotics and sustainably increase industrial performance using digital twin technology and physical AI. The conference is regarded as the most important international meeting point for AI developers, researchers and decision makers. This year, more than 30,000 participants from over 190 countries are expected to attend. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260313000399/en/ By attending NVIDIA GTC, Reply is showcasing how digital simulation and physical automation are already being integrated in practice. Projects for the Otto Group and the industrial edge domain show how physical AI and precise digital twins work together to create new opportunities for industrial value generation. The focus will be on two concrete use cases that demon
Klarna Board Chair Michael Moritz Acquires 3.47 Million Shares for $50 Million13.3.2026 12:05:00 EET | Press release
Klarna Group plc (NYSE: KLAR) today discloses the following transactions by the Chair of its Board of Directors and Chief Product & Design Officer, filed with the U.S. Securities and Exchange Commission on Form 3. Share Purchases Michael Moritz, Chairman, through an associated entity, purchased 3,472,845 ordinary shares between March 3 and March 11, 2026, at an aggregate consideration of $49,913,138.73. David Fock, Chief Product & Design Officer, purchased 27,000 ordinary shares on March 9, 2026, for an aggregate consideration of $388,552.14. Share Sales David Sandström, Chief Marketing Officer, sold 32,703 shares on March 9, 2026, pursuant to a Rule 10b5-1 trading plan, established in 2025. David Sykes, Chief Commercial Officer, sold 23,799 shares on March 13, 2026, pursuant to a separately established Rule 10b5-1 trading plan, established in 2025. Form 3 filings for all transactions are available on the SEC's EDGAR database atwww.sec.gov. Forward-Looking Statements This press release
Intertek Launches Comprehensive Digital Product Passport Services13.3.2026 11:00:00 EET | Press release
Intertek, a leading Total Quality Assurance provider to industries worldwide, has announced the launch of its enhanced Digital Product Passport (DPP) suite of services. This includes a comprehensive advisory service designed to help manufacturers, brands and retailers navigate the fast-evolving regulatory and sustainability landscape associated with digital product passports and circular economy compliance. Mark Thomas, Executive Vice President, Global Sustainability, Assurance, Agri World and Food at Intertek, said: “With the introduction of regulatory frameworks for improving the sustainability performance of products, companies are facing mounting pressure to implement robust systems for transparency, traceability and sustainability reporting globally. This shift marks a significant regulatory milestone, requiring organisations to strengthen data governance, engage suppliers more effectively and demonstrate credible, verifiable sustainability performance across the full product life
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