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
Diplomacy, Business, Innovation : SIAL Paris 2026 at the Heart of Global Food Challenges5.11.2026 11:00:00 EET | Press release
305,000 professionals, 8,000 exhibitors and 192 countries and regions represented: SIAL Paris reaffirms its role as a global platform for influence, business and food innovation. Held under the High Patronage of the President of the French Republic, SIAL Paris closed its doors on October 21 after five days that made Paris the centre of gravity for the global food industry. A meeting of G7 Agriculture Ministers, India as Country of Honour and food sovereignty were among the defining highlights of this edition. SIAL Paris, where nations come together Against a backdrop of geopolitical tensions and shifting international trade dynamics, SIAL Paris reinforced its role as a platform for international dialogue. On October 19, a high-level meeting dedicated to food security and sovereignty brought together Agriculture Ministers and G7 representatives, alongside European Commissioner Christophe Hansen. More than 100 diplomatic and international delegations attended the event. This internationa
Festo, Softcat, ANS Group and SCC Demonstrate the Business Impact of AI-Powered Observability5.11.2026 10:00:00 EET | Press release
LogicMonitor®, the AI-first platform for Autonomous IT, announced the 2026 Elevate Award winners today at its Elevate Community Conference in London. The annual awards recognize LogicMonitor customers and partners that are achieving measurable business and operational outcomes through AI-powered observability. From consolidating 90% of monitoring tools and reducing alert noise by 85% to cutting observability case volumes by 45%, this year's EMEA winners demonstrate how organizations are simplifying complex IT environments, improving resilience and putting AI-powered operations into practice. “This year's EMEA Elevate Award winners are proving that the path to Autonomous IT starts with real, measurable improvements in how organizations operate,” said John Grosshans, President of Field Operations, LogicMonitor. “They're reducing complexity, giving teams time back and using AI to make better decisions and take more effective action. We're proud to recognize their achievements and the impa
New AGCO Power CORE Engines to Power Two New Tractors at EIMA 20265.11.2026 08:00:00 EET | Press release
At EIMA International in Bologna, Italy, on November 10–14, 2026, visitors will be able to see how the AGCO Power CORE75 engine platform supports the different requirements of the Massey Ferguson new model MF 7S MARK 2 range and Valtra’s new sixth-generation Valtra T Series. A CORE75 engine will also be on display at the Valtra stand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104588496/en/ Massey Ferguson 7S MARK 2 The CORE engine family represents AGCO Power’s investment in a completely new engine platform at a time when few manufacturers are making comparable commitments to off-highway combustion engine development. The CORE engine family is designed to meet different power requirements, emissions regulations and machine integration needs. Its design combines fuel efficiency, strong low-speed torque and responsive performance for applications that demand dependable power over long working days. The family includes
SPIE Announces 2027 Prism Awards Finalists for Best Photonics Products4.11.2026 22:22:00 EET | Press release
SPIE, the international society for optics and photonics, has announced finalists in the seven categories for the 2027 Prism Awards, which recognize remarkable new photonics products on the market. Winners will be announced during the awards ceremony at SPIE Photonics West on 3 February 2027 in San Francisco, California. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104613876/en/ SPIE has announced the finalists for the 2027 SPIE Prism Awards, which recognize optics and photonics innovations. Recipients will be announced at the awards ceremony on 3 February 2027 at SPIE Photonics West. During the Prism Awards, SPIE will also announce the winner of the SPIE Catalyst Award, honoring a for-profit company with social or environmental programs that have made significant advances in workplace opportunity, community engagement, or environmental progress. Finalists for this year’s Catalyst Award, now in its fourth year, are Lume
Every Critical System Should Have a Backup: Elliptic Opens Up Fast Track Monitoring to the Crypto Industry4.11.2026 22:07:00 EET | Press release
Elliptic, the leader in on-chain risk management, is making Fast Track Monitoring available to firms with digital assets exposure as a back up screening option for firms that need business continuity, if their primary screening service is unavailable and they need a second option. Criminals are increasingly using AI to scale their attacks, so on-chain risk now moves at machine speed. Compliance teams need the broadest range of options to keep screening every wallet and transaction, and a second screening provider builds resilience into any on-chain risk management approach. Elliptic recommends every business has one in place. Organizations that rely on a single screening vendor can also still need a second option. Fast Track Monitoring gives compliance teams real-time wallet and transaction screening powered by Elliptic Lens, with a clear, explainable risk score on every wallet and transaction. When screening stops, a compliance lead faces two hard choices: hold customer withdrawals, o
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