MA-NUMARES
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/
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/
View source version on businesswire.com: https://www.businesswire.com/news/home/20210324005057/en/
About Business Wire
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
Avanzanite Bioscience Secures €32M Series A Investment from MVM Partners18.11.2025 07:00:00 CET | Press release
MVM Partners joins as Avanzanite’s first institutional investor. Funding will scale Avanzanite’s existing infrastructure in all 32 countries in Europe, propel current launches, and support further product alliances and acquisitions. In just 3 years, Avanzanite has entered 3 strategic alliances and actively launched 3 rare disease medicines. Avanzanite’s Q3 2025 revenue tripled year-on-year and climbed over 20% quarter-on-quarter. Avanzanite is a unique, fully integrated partner for biotech and pharma innovators seeking to market and distribute their rare disease medicines in Europe. A new pan-European standard is being set for orphan medicine launches and patient access, with no one left behind. Avanzanite Bioscience B.V. (Avanzanite), a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today announced a €32 million Series A growth investment from MVM Partners (MVM), a leading global life-science private equity firm. This press release
Over 30 Million Users Benefit From Ant International’s Bettr Credit Tech Solutions18.11.2025 04:35:00 CET | Press release
Powering the Next Wave of MSME Growth with Digital Platforms in Emerging MarketsThere was a threefold year-on-year increase in eligible customers reached through partners using Bettr's credit tech solutions by the end of October 2025.The solution features an AI-driven, alternative-data-powered credit engine that can help partner platforms to cut credit policy deployment from weeks to minutes.Partnership with Dock, a leading Brazilian payments and banking technology provider, will expand the deployment of Bettr’s credit tech solutions. Bettr, a leading provider of inclusive financial services and technology business under Ant International, today announced the launch of its proprietary tailored, one-stop credit tech solutions designed to help digital platforms build and scale their lending businesses to better serve micro, small and medium enterprises (MSMEs) in emerging markets. Bettr's credit tech solutions supported over 30 million customers to gain access to credit services through
Ant International Deepens Participation in Project Ensemble as New Architecture Community Member18.11.2025 04:00:00 CET | Press release
Ant International has been a participant in the Ensemble Sandbox since 2024 Ant International today announced it has joined Project Ensemble’s Architecture Community to support the design and advancement of Hong Kong’s tokenisation ecosystem. As a Community member, it will be more involved in defining industry standards and supporting the development of Hong Kong’s tokenisation market, together with the Hong Kong Monetary Authority (HKMA) and leading peers. A fintech representative on the Community, Ant International will also contribute its technological and innovation capabilities in tokenisation to support broader industry adoption. This comes at a time when Project Ensemble reaches a new milestone with EnsembleTX, which will see it move from sandbox experiments to live market use within a pilot environment. Through EnsembleTX, Ant International will continue to broaden its partnerships with banks and other committee members, contributing to real-world use cases of tokenisation in r
Celltrion Announces European Commission Approval of Additional Line Extension for Omlyclo™ 300mg18.11.2025 03:51:00 CET | Press release
Omlyclo™ (omalizumab) is the first and only omalizumab biosimilar approved in EuropeOmlyclo™ 300 mg/2ml prefilled syringe (PFS) presentation is now approved in EU offering a simpler dosing schedule and improved patient adherence The European Commission (EC) has granted a line extension in the European Union (EU) for Celltrion’s Omlyclo™ (omalizumab), Europe’s first and only omalizumab biosimilar, for the 300 mg/2ml prefilled syringe (PFS).The European Commission (EC) approved Omlyclo™ 75 mg/0.5ml and 150mg/1ml solution for injection in pre-filled syringe in May 2024. Omlyclo™ is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). “The additional strength of Omlyclo™ 300mg can significantly decrease the frequency of injections, and reduce injection burden and discomfort, without compromising efficacy and safety,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “These
2026 Mitsui Chemicals Catalysis Science Awards18.11.2025 03:00:00 CET | Press release
Online applications are open until December 25, 2025 Mitsui Chemicals, Inc. has announced that online applications for the 2026 Mitsui Chemicals Catalysis Science Award have been open since September 1, 2025. The application period will run from September 1 to December 25, 2025. Aiming to contribute to the sustainable development of chemistry and the chemical industry, Mitsui Chemicals established the Mitsui Chemicals Catalysis Science Awards in 2004. The awards consist of the Catalysis Science Award and the Catalysis Science Award for Creative Work, which recognize outstanding achievements in the field of catalysis science. To date, the awards have been conferred on 33 researchers within Japan and overseas. Past recipients include individuals who have gone on to be highly acclaimed worldwide, receiving honors such as the Nobel Prize in Chemistry and other prestigious Japanese and international awards. We welcome applications from a wide range of R&D fields, including solid catalysts,
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